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1. Synergistic T cell signaling by 41BB and CD28 is optimally achieved by membrane proximal positioning within parallel chimeric antigen receptors

Author

Muliaditan, Tamara, Halim, Leena, Whilding, Lynsey M., Draper, Benjamin, Achkova, Daniela Y., Kausar, Fahima, Glover, Maya, Bechman, Natasha, Arulappu, Appitha, Sanchez, Jenifer, Flaherty, Katie R., Obajdin, Jana, Grigoriadis, Kristiana, Antoine, Pierre, Larcombe-Young, Daniel, Hull, Caroline M., Buus, Richard, Gordon, Peter, Grigoriadis, Anita, Davies, David M., Schurich, Anna, and Maher, John

Published
2021
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3. Tolerability, safety and intermediary pharmacological effects of cilostazol and isosorbide mononitrate, alone and combined, in patients with lacunar ischaemic stroke: The LACunar Intervention-1 (LACI-1) trial, a randomised clinical trial

Author

Blair, Gordon W., Appleton, Jason P., Flaherty, Katie, Doubal, Fergus, Sprigg, Nikola, Dooley, Richard, Richardson, Carla, Hamilton, Iona, Law, Zhe Kang, Shi, Yulu, Stringer, Michael S., Thrippleton, Michael J., Boyd, Julia, Shuler, Kirsten, Bath, Philip M., and Wardlaw, Joanna M.

Published
2019
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5. Effects of Cilostazol and Isosorbide Mononitrate on Cerebral Hemodynamics in the LACI-1 Randomized Controlled Trial

Author

Blair, Gordon W., primary, Janssen, Esther, additional, Stringer, Michael S., additional, Thrippleton, Michael J., additional, Chappell, Francesca, additional, Shi, Yulu, additional, Hamilton, Iona, additional, Flaherty, Katie, additional, Appleton, Jason P., additional, Doubal, Fergus N., additional, Bath, Philip M., additional, and Wardlaw, Joanna M., additional

Published
2022
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6. Synergistic T cell signaling by 41BB and CD28 is optimally achieved by membrane proximal positioning within parallel chimeric antigen receptors

Author

Afd Pharmacology, Pharmacology, Muliaditan, Tamara, Halim, Leena, Whilding, Lynsey M, Draper, Benjamin, Achkova, Daniela Y, Kausar, Fahima, Glover, Maya, Bechman, Natasha, Arulappu, Appitha, Sanchez, Jenifer, Flaherty, Katie R, Obajdin, Jana, Grigoriadis, Kristiana, Antoine, Pierre, Larcombe-Young, Daniel, Hull, Caroline M, Buus, Richard, Gordon, Peter, Grigoriadis, Anita, Davies, David M, Schurich, Anna, Maher, John, Afd Pharmacology, Pharmacology, Muliaditan, Tamara, Halim, Leena, Whilding, Lynsey M, Draper, Benjamin, Achkova, Daniela Y, Kausar, Fahima, Glover, Maya, Bechman, Natasha, Arulappu, Appitha, Sanchez, Jenifer, Flaherty, Katie R, Obajdin, Jana, Grigoriadis, Kristiana, Antoine, Pierre, Larcombe-Young, Daniel, Hull, Caroline M, Buus, Richard, Gordon, Peter, Grigoriadis, Anita, Davies, David M, Schurich, Anna, and Maher, John

Published
2021

7. Tranexamic Acid for Prevention of Hematoma Expansion in Intracerebral Hemorrhage Patients with or without Spot Sign

Author

Ovesen, Christian, Jakobsen, Janus Christian, Gluud, Christian, Steiner, Thorsten, Law, Zhe, Flaherty, Katie, Dineen, Rob A., Christensen, Louisa M., Overgaard, Karsten, Rasmussen, Rune S., Bath, Philip M., Sprigg, Nikola, Christensen, Hanne, Ovesen, Christian, Jakobsen, Janus Christian, Gluud, Christian, Steiner, Thorsten, Law, Zhe, Flaherty, Katie, Dineen, Rob A., Christensen, Louisa M., Overgaard, Karsten, Rasmussen, Rune S., Bath, Philip M., Sprigg, Nikola, and Christensen, Hanne

Abstract

Background and Purpose: The computed tomography angiography or contrast-enhanced computed tomography based spot sign has been proposed as a biomarker for identifying on-going hematoma expansion in patients with acute intracerebral hemorrhage. We investigated, if spot-sign positive participants benefit more from tranexamic acid versus placebo as compared to spot-sign negative participants. Methods: TICH-2 trial (Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage) was a randomized, placebo-controlled clinical trial recruiting acutely hospitalized participants with intracerebral hemorrhage within 8 hours after symptom onset. Local investigators randomized participants to 2 grams of intravenous tranexamic acid or matching placebo (1:1). All participants underwent computed tomography scan on admission and on day 2 (24±12 hours) after randomization. In this sub group analysis, we included all participants from the main trial population with imaging allowing adjudication of spot sign status. Results: Of the 2325 TICH-2 participants, 254 (10.9%) had imaging allowing for spot-sign adjudication. Of these participants, 64 (25.2%) were spot-sign positive. Median (interquartile range) time from symptom onset to administration of the intervention was 225.0 (169.0 to 310.0) minutes. The adjusted percent difference in absolute day-2 hematoma volume between participants allocated to tranexamic versus placebo was 3.7% (95% CI,-12.8% to 23.4%) for spot-sign positive and 1.7% (95% CI,-8.4% to 12.8%) for spot-sign negative participants (Pheterogenity=0.85). No difference was observed in significant hematoma progression (dichotomous composite outcome) between participants allocated to tranexamic versus placebo among spot-sign positive (odds ratio, 0.85 [95% CI, 0.29 to 2.46]) and negative (odds ratio, 0.77 [95% CI, 0.41 to 1.45]) participants (Pheterogenity=0.88). Conclusions: Data from the TICH-2 trial do not support that admission spot sign status

Published
2021

9. Tranexamic acid to improve functional status in adults with spontaneous intracerebral haemorrhage: the TICH-2 RCT

Author

Sprigg, Nikola, Flaherty, Katie, Appleton, Jason P, Al-Shahi Salman, Rustam, Bereczki, Daniel, Beridze, Maia, Ciccone, Alfonso, Collins, Ronan, Dineen, Robert A, Duley, Lelia, England, Timothy J, Karlinski, Michal, Krishnan, Kailash, Laska, Ann Charlotte, Law, Zhe Kang, Ovesen, Christian, Ozturk, Serefnur, Pocock, Stuart J, Roberts, Ian, Robinson, Thompson G, Roffe, Christine, Peters, Nils, Scutt, Polly, Thanabalan, Jegan, Werring, David, Whynes, David, Woodhouse, Lisa, and Bath, Philip M

Subjects
Health Policy
Abstract

BACKGROUND: Tranexamic acid reduces death due to bleeding after trauma and postpartum haemorrhage. OBJECTIVE: The aim of the study was to assess if tranexamic acid is safe, reduces haematoma expansion and improves outcomes in adults with spontaneous intracerebral haemorrhage (ICH). DESIGN: The TICH-2 (Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage) study was a pragmatic, Phase III, prospective, double-blind, randomised placebo-controlled trial. SETTING: Acute stroke services at 124 hospitals in 12 countries (Denmark, Georgia, Hungary, Ireland, Italy, Malaysia, Poland, Spain, Sweden, Switzerland, Turkey and the UK). PARTICIPANTS: Adult patients (aged ??18 years) with ICH within 8 hours of onset. EXCLUSION CRITERIA: Exclusion criteria were ICH secondary to anticoagulation, thrombolysis, trauma or a known underlying structural abnormality; patients for whom tranexamic acid was thought to be contraindicated; prestroke dependence (i.e. patients with a modified Rankin Scale [mRS] score >?4); life expectancy

Published
2019

10. Characteristics and outcomes of patients with or without a bleeding event: results from the triple antiplatelets for reducing dependency in ischaemic stroke (TARDIS) trial

Author

Woodhouse, Lisa J., Flaherty, Katie, Appleton, Jason P., Sprigg, Nikola, Bath, Philip M.W., and The TARDIS Investigators

Abstract

Background: Several studies showed that hyperglycaemia is associated with poorer prognosis in intracerebral haemorrhage. We explored the characteristics and outcomes of patients with hyperglycaemia in the Tranexamic acid in IntraCerebral Haemorrhage-2 (TICH-2) trial.\ud Methods: Of the 2325 patients recruited, 2028 with available baseline glucose levels were included for analysis. Baseline characteristics, radiological and clinical outcomes were compared between patients with admission glucose levels of

Published
2018

11. MOESM2 of Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial

Author

Ovesen, Christian, Jakobsen, Janus, Gluud, Christian, Steiner, Thorsten, Law, Zhe, Flaherty, Katie, Dineen, Rob, Bath, Philip, Sprigg, Nikola, and Christensen, Hanne

Abstract

Additional file 2. Power calculationsâ power calculations of primary and secondary outcomes.

Published
2018
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12. Effects of Isosorbide Mononitrate and/or Cilostazol on Hematological Markers, Platelet Function, and Hemodynamics in Patients With Lacunar Ischaemic Stroke: Safety Data From the Lacunar Intervention-1 (LACI-1) Trial

Author

Appleton, Jason P., primary, Blair, Gordon W., additional, Flaherty, Katie, additional, Law, Zhe Kang, additional, May, Jane, additional, Woodhouse, Lisa J., additional, Doubal, Fergus, additional, Sprigg, Nikola, additional, Bath, Philip M., additional, and Wardlaw, Joanna M., additional

Published
2019
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14. Antiplatelet therapy with aspirin, clopidogrel, and dipyridamole versus clopidogrel alone or aspirin and dipyridamole in patients with acute cerebral ischaemia (TARDIS):a randomised, open-label, phase 3 superiority trial

Author

Bath, Philip M, Woodhouse, Lisa J, Appleton, Jason P, Beridze, Maia, Christensen, Hanne, Dineen, Robert A, Duley, Lelia, England, Timothy J, Flaherty, Katie, Havard, Diane, Heptinstall, Stan, James, Marilyn, Krishnan, Kailash, Markus, Hugh S, Montgomery, Alan A, Pocock, Stuart J, Randall, Marc, Ranta, Annemarei, Robinson, Thompson G, Scutt, Polly, Venables, Graham S, Sprigg, Nikola, Bath, Philip M, Woodhouse, Lisa J, Appleton, Jason P, Beridze, Maia, Christensen, Hanne, Dineen, Robert A, Duley, Lelia, England, Timothy J, Flaherty, Katie, Havard, Diane, Heptinstall, Stan, James, Marilyn, Krishnan, Kailash, Markus, Hugh S, Montgomery, Alan A, Pocock, Stuart J, Randall, Marc, Ranta, Annemarei, Robinson, Thompson G, Scutt, Polly, Venables, Graham S, and Sprigg, Nikola

Abstract

BACKGROUND: Intensive antiplatelet therapy with three agents might be more effective than guideline treatment for preventing recurrent events in patients with acute cerebral ischaemia. We aimed to compare the safety and efficacy of intensive antiplatelet therapy (combined aspirin, clopidogrel, and dipyridamole) with that of guideline-based antiplatelet therapy.METHODS: We did an international, prospective, randomised, open-label, blinded-endpoint trial in adult participants with ischaemic stroke or transient ischaemic attack (TIA) within 48 h of onset. Participants were assigned in a 1:1 ratio using computer randomisation to receive loading doses and then 30 days of intensive antiplatelet therapy (combined aspirin 75 mg, clopidogrel 75 mg, and dipyridamole 200 mg twice daily) or guideline-based therapy (comprising either clopidogrel alone or combined aspirin and dipyridamole). Randomisation was stratified by country and index event, and minimised with prognostic baseline factors, medication use, time to randomisation, stroke-related factors, and thrombolysis. The ordinal primary outcome was the combined incidence and severity of any recurrent stroke (ischaemic or haemorrhagic; assessed using the modified Rankin Scale) or TIA within 90 days, as assessed by central telephone follow-up with masking to treatment assignment, and analysed by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN47823388.FINDINGS: 3096 participants (1556 in the intensive antiplatelet therapy group, 1540 in the guideline antiplatelet therapy group) were recruited from 106 hospitals in four countries between April 7, 2009, and March 18, 2016. The trial was stopped early on the recommendation of the data monitoring committee. The incidence and severity of recurrent stroke or TIA did not differ between intensive and guideline therapy (93 [6%] participants vs 105 [7%]; adjusted common odds ratio [cOR] 0·90, 95% CI 0·67-1·20, p=0·47). By contrast, i

Published
2018

15. Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan:a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial

Author

Ovesen, Christian, Jakobsen, Janus Christian, Gluud, Christian, Steiner, Thorsten, Law, Zhe, Flaherty, Katie, Dineen, Rob A, Bath, Philip M, Sprigg, Nikola, Christensen, Hanne, Ovesen, Christian, Jakobsen, Janus Christian, Gluud, Christian, Steiner, Thorsten, Law, Zhe, Flaherty, Katie, Dineen, Rob A, Bath, Philip M, Sprigg, Nikola, and Christensen, Hanne

Abstract

OBJECTIVE: We present the statistical analysis plan of a prespecified Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 sub-study aiming to investigate, if tranexamic acid has a different effect in intracerebral haemorrhage patients with the spot sign on admission compared to spot sign negative patients. The TICH-2 trial recruited above 2000 participants with intracerebral haemorrhage arriving in hospital within 8 h after symptom onset. They were included irrespective of radiological signs of on-going haematoma expansion. Participants were randomised to tranexamic acid versus matching placebo. In this subgroup analysis, we will include all participants in TICH-2 with a computed tomography angiography on admission allowing adjudication of the participants' spot sign status.RESULTS: Primary outcome will be the ability of tranexamic acid to limit absolute haematoma volume on computed tomography at 24 h (± 12 h) after randomisation among spot sign positive and spot sign negative participants, respectively. Within all outcome measures, the effect of tranexamic acid in spot sign positive/negative participants will be compared using tests of interaction. This sub-study will investigate the important clinical hypothesis that spot sign positive patients might benefit more from administration of tranexamic acid compared to spot sign negative patients. Trial registration ISRCTN93732214 ( http://www.isrctn.com ).

Published
2018

16. Triple versus guideline antiplatelet therapy to prevent recurrence after acute ischaemic stroke or transient ischaemic attack:The TARDIS RCT

Author

Bath, Philip M., Woodhouse, Lisa J., Appleton, Jason P., Beridze, Maia, Christensen, Hanne, Dineen, Robert A., Flaherty, Katie, Duley, Lelia, England, Timothy J., Havard, Diane, Heptinstall, Stan, James, Marilyn, Kasonde, Chibeka, Krishnan, Kailash, Markus, Hugh S., Montgomery, Alan A., Pocock, Stuart, Randall, Marc, Ranta, Annamarei, Robinson, Thompson G., Scutt, Polly, Venables, Graham S., Sprigg, Nikola, Bath, Philip M., Woodhouse, Lisa J., Appleton, Jason P., Beridze, Maia, Christensen, Hanne, Dineen, Robert A., Flaherty, Katie, Duley, Lelia, England, Timothy J., Havard, Diane, Heptinstall, Stan, James, Marilyn, Kasonde, Chibeka, Krishnan, Kailash, Markus, Hugh S., Montgomery, Alan A., Pocock, Stuart, Randall, Marc, Ranta, Annamarei, Robinson, Thompson G., Scutt, Polly, Venables, Graham S., and Sprigg, Nikola

Abstract

Background: Two antiplatelet agents are better than one for preventing recurrent stroke after acute ischaemic stroke or transient ischaemic attack (TIA). Therefore, intensive treatment with three agents might be better still, providing it does not cause undue bleeding. Objective: To compare the safety and efficacy of intensive therapy with guideline antiplatelet therapy for acute ischaemic stroke and TIA. Design: International prospective randomised open-label blinded end-point parallel-group superiority clinical trial. Setting: Acute hospitals at 106 sites in four countries. Participants: Patients > 50 years of age with acute non-cardioembolic ischaemic stroke or TIA within 48 hours of ictus (stroke). Interventions: Participants were allocated at random by computer to 1 month of intensive (combined aspirin, clopidogrel and dipyridamole) or guideline (combined aspirin and dipyridamole, or clopidogrel alone) antiplatelet agents, and followed for 90 days. Main outcome measures: The primary outcome was the incidence and severity of any recurrent stroke (ischaemic, haemorrhagic; assessed using the modified Rankin Scale) or TIA within 90 days by blinded telephone follow-up. Analysis using ordinal logistic regression was by intention to treat. Other outcomes included bleeding and its severity, death, myocardial infarction (MI), disability, mood, cognition and quality of life. Results: The trial was stopped early on the recommendation of the Data Monitoring Committee after recruitment of 3096 participants (intensive, n = 1556; guideline, n = 1540) from 106 hospitals in four countries between April 2009 and March 2016. The incidence and severity of recurrent stroke or TIA did not differ between intensive and guideline therapy in 3070 (99.2%) participants with data [93 vs. 105 stroke/TIA events; adjusted common odds ratio 0.90, 95% confidence interval (CI) 0.67 to 1.20; p = 0.47]. Major (encompassing fatal) bleeding was increased with intensive as compared with guideli

Published
2018

17. Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2):an international randomised, placebo-controlled, phase 3 superiority trial

Author

Sprigg, Nikola, Flaherty, Katie, Appleton, Jason P, Al-Shahi Salman, Rustam, Bereczki, Daniel, Beridze, Maia, Christensen, Hanne, Ciccone, Alfonso, Collins, Ronan, Czlonkowska, Anna, Dineen, Robert A, Duley, Lelia, Egea-Guerrero, Juan Jose, England, Timothy J, Krishnan, Kailash, Laska, Ann Charlotte, Law, Zhe Kang, Ozturk, Serefnur, Pocock, Stuart J, Roberts, Ian, Robinson, Thompson G, Roffe, Christine, Seiffge, David, Scutt, Polly, Thanabalan, Jegan, Werring, David, Whynes, David, Bath, Philip M, Sprigg, Nikola, Flaherty, Katie, Appleton, Jason P, Al-Shahi Salman, Rustam, Bereczki, Daniel, Beridze, Maia, Christensen, Hanne, Ciccone, Alfonso, Collins, Ronan, Czlonkowska, Anna, Dineen, Robert A, Duley, Lelia, Egea-Guerrero, Juan Jose, England, Timothy J, Krishnan, Kailash, Laska, Ann Charlotte, Law, Zhe Kang, Ozturk, Serefnur, Pocock, Stuart J, Roberts, Ian, Robinson, Thompson G, Roffe, Christine, Seiffge, David, Scutt, Polly, Thanabalan, Jegan, Werring, David, Whynes, David, and Bath, Philip M

Abstract

BACKGROUND: Tranexamic acid can prevent death due to bleeding after trauma and post-partum haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke due to intracerebral haemorrhage.METHODS: We did an international, randomised placebo-controlled trial in adults with intracerebral haemorrhage from acute stroke units at 124 hospital sites in 12 countries. Participants were randomly assigned (1:1) to receive 1 g intravenous tranexamic acid bolus followed by an 8 h infusion of 1 g tranexamic acid or a matching placebo, within 8 h of symptom onset. Randomisation was done centrally in real time via a secure website, with stratification by country and minimisation on key prognostic factors. Treatment allocation was concealed from patients, outcome assessors, and all other health-care workers involved in the trial. The primary outcome was functional status at day 90, measured by shift in the modified Rankin Scale, using ordinal logistic regression with adjustment for stratification and minimisation criteria. All analyses were done on an intention-to-treat basis. This trial is registered with the ISRCTN registry, number ISRCTN93732214.FINDINGS: We recruited 2325 participants between March 1, 2013, and Sept 30, 2017. 1161 patients received tranexamic acid and 1164 received placebo; the treatment groups were well balanced at baseline. The primary outcome was assessed for 2307 (99%) participants. The primary outcome, functional status at day 90, did not differ significantly between the groups (adjusted odds ratio [aOR] 0·88, 95% CI 0·76-1·03, p=0·11). Although there were fewer deaths by day 7 in the tranexamic acid group (101 [9%] deaths in the tranexamic acid group vs 123 [11%] deaths in the placebo group; aOR 0·73, 0·53-0·99, p=0·0406), there was no difference in case fatality at 90 days (250 [22%] vs 249 [21%]; adjusted hazard ratio 0·92, 95% CI 0·77-1·10, p=0·37). Fewer patients had seriou

Published
2018

18. Triple versus guideline antiplatelet therapy to prevent recurrence after acute ischaemic stroke or transient ischaemic attack: the TARDIS RCT

Author

Bath, Philip M, primary, Woodhouse, Lisa J, additional, Appleton, Jason P, additional, Beridze, Maia, additional, Christensen, Hanne, additional, Dineen, Robert A, additional, Flaherty, Katie, additional, Duley, Lelia, additional, England, Timothy J, additional, Havard, Diane, additional, Heptinstall, Stan, additional, James, Marilyn, additional, Kasonde, Chibeka, additional, Krishnan, Kailash, additional, Markus, Hugh S, additional, Montgomery, Alan A, additional, Pocock, Stuart, additional, Randall, Marc, additional, Ranta, Annamarei, additional, Robinson, Thompson G, additional, Scutt, Polly, additional, Venables, Graham S, additional, and Sprigg, Nikola, additional

Published
2018
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19. Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trial

Author

Sprigg, Nikola, primary, Flaherty, Katie, additional, Appleton, Jason P, additional, Salman, Rustam Al-Shahi, additional, Bereczki, Daniel, additional, Beridze, Maia, additional, Christensen, Hanne, additional, Ciccone, Alfonso, additional, Collins, Ronan, additional, Czlonkowska, Anna, additional, Dineen, Robert A, additional, Duley, Lelia, additional, Egea-Guerrero, Juan Jose, additional, England, Timothy J, additional, Krishnan, Kailash, additional, Laska, Ann Charlotte, additional, Law, Zhe Kang, additional, Ozturk, Serefnur, additional, Pocock, Stuart J, additional, Roberts, Ian, additional, Robinson, Thompson G, additional, Roffe, Christine, additional, Seiffge, David, additional, Scutt, Polly, additional, Thanabalan, Jegan, additional, Werring, David, additional, Whynes, David, additional, and Bath, Philip M, additional

Published
2018
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20. Antiplatelet therapy with aspirin, clopidogrel, and dipyridamole versus clopidogrel alone or aspirin and dipyridamole in patients with acute cerebral ischaemia (TARDIS): a randomised, open-label, phase 3 superiority trial

Author

Bath, Philip M, primary, Woodhouse, Lisa J, additional, Appleton, Jason P, additional, Beridze, Maia, additional, Christensen, Hanne, additional, Dineen, Robert A, additional, Duley, Lelia, additional, England, Timothy J, additional, Flaherty, Katie, additional, Havard, Diane, additional, Heptinstall, Stan, additional, James, Marilyn, additional, Krishnan, Kailash, additional, Markus, Hugh S, additional, Montgomery, Alan A, additional, Pocock, Stuart J, additional, Randall, Marc, additional, Ranta, Annemarei, additional, Robinson, Thompson G, additional, Scutt, Polly, additional, Venables, Graham S, additional, Sprigg, Nikola, additional, Christensen, L M, additional, Bentsen, L, additional, Krarup Hansen, C, additional, Thomsen, T T, additional, Kruuse, C, additional, Jensen, H H, additional, Hansen, S S, additional, Petrovic, V, additional, Beridze, N, additional, Kakabadze, N, additional, Kherkheulidze, T, additional, Kakabadze, D, additional, Toidze, I, additional, Lobjanidze, N, additional, Akiashvili, N, additional, Tevdoradze, A, additional, Khizanishvili, N, additional, Tsanava, T, additional, Taylor, R, additional, Iniesta, I, additional, Kok, J, additional, Duignan, J, additional, Funnell, M, additional, Cariga, P, additional, Rodriguez, M, additional, Watson, I J, additional, Tennant, S, additional, Macleod, M, additional, Furnace, J, additional, Gow, H, additional, Irvine, J, additional, Joyson, A, additional, Nelson, S, additional, Taylor, V, additional, Smith, M, additional, Bellfield, R, additional, Hairsine, B, additional, Davies, R, additional, Dodd, A, additional, Corrigan, J, additional, Doherty, M, additional, Ahmed, A, additional, Denniss, C, additional, Johnson-Holland, S, additional, Kay, K A, additional, Palau, R Icart, additional, Auld, G, additional, Daboo, P, additional, Erande, R, additional, Grimwood, G, additional, Hove, D, additional, Howaniec, L, additional, Redjep, O, additional, Rangasamay, R, additional, Butt, G, additional, Sandler, D, additional, Reddan, J, additional, Stafford, S, additional, McIlmoyle, J, additional, Maguire, S, additional, Murphy, P, additional, Chambers, J, additional, Guthrie, L, additional, Osborn, M, additional, Steele, A, additional, Burn, M, additional, Benford, A, additional, Misra, A, additional, Hilton, D, additional, O'Brien, E, additional, Amis, E, additional, Finlay, S, additional, Mitchell, J, additional, Geraghty, O, additional, Harvey, K, additional, Hazel, B, additional, Mashate, S, additional, Wilding, P, additional, Sajid, M, additional, Ball, M, additional, Gascoyne, R, additional, Sivakumar, R, additional, Wright, A, additional, Chatterjee, K, additional, Booth, S, additional, Eccleson, H, additional, Kelly, C, additional, Leason, S, additional, Perkins, C, additional, Bruce, D, additional, Brown, E, additional, Clayton, S, additional, Garside, M, additional, Rogers, G, additional, Lawrence, E, additional, Mahmood, S, additional, Watchurst, C, additional, Chadha, D, additional, Glover, L, additional, Holford, L, additional, Smith, K, additional, Walstow, D, additional, Williams, R, additional, O'Shea, L, additional, Goodsell, J, additional, Athulathmudali, C, additional, Barbon, E, additional, Namushi, R, additional, Jacob, P, additional, Johnson, L, additional, Morse, D, additional, McGhee, C, additional, Speirs, O, additional, Atkinson, S, additional, Peacocke, A, additional, Langhorne, P, additional, Graham, R, additional, Wright, F, additional, McAlpine, C, additional, Ravindrane, A, additional, Bajoriene, M, additional, Matter, L, additional, Windebank, S, additional, Giallombardo, E, additional, Dellafera, D, additional, Eglinton, C, additional, Wilson, J, additional, Broughton, D, additional, Chapman, K, additional, Dixon, L, additional, Zaidi, M, additional, Ayes, K, additional, Kessell, J, additional, Manawadu, D, additional, Adegbaju, O, additional, Aeron-Thomas, J, additional, Anderson, K, additional, Brigden, A, additional, Cattermole, E, additional, Good, J, additional, Hassan, S, additional, Khoromana, E, additional, Lee-Carbon, L, additional, Marks, K, additional, Mckenzie, E, additional, Sikondari, N, additional, Cooper, M, additional, Whysall, K, additional, Wynter, I, additional, Bamford, J, additional, Hassan, A, additional, Wanklyn, P, additional, Kambafwile, M, additional, Makawa, L, additional, Waugh, D, additional, Veraque, E, additional, Soliman, MGG, additional, Arif, S, additional, Brown, R, additional, Butler, S, additional, Hewitt, C, additional, Hindle, J, additional, Pusalkar, A, additional, Beadle, H, additional, Chan, K, additional, Siddiqui, M, additional, Dangri, P, additional, Buddha, S, additional, Asokanathan, A, additional, Mistri, A, additional, Eveson, D, additional, Musarrat, K, additional, Manning, L, additional, Anand, S, additional, Christian, P, additional, Khan, S, additional, Patel, C, additional, Sein, M, additional, Banns, J, additional, Gibson, E, additional, Gordon, T, additional, Gruenbeck, Y, additional, Wong, S, additional, Datta, P, additional, Bateman, G, additional, Jackson, L, additional, Needle, A, additional, Duodu, Y, additional, Oliver, R, additional, Padilla-Harris, C, additional, Barber, M, additional, Esson, D, additional, Brodie, F, additional, McInnes, C, additional, Fotherby, K, additional, Butler, D, additional, Morgan, D, additional, Preece, K, additional, Willberry, A, additional, Dent, M, additional, Hammonds, F, additional, Hunt, J, additional, Vernon, C, additional, O'Kane, D, additional, Faola, F, additional, Lai, P, additional, O'Callaghan, J, additional, Smith, C, additional, Price, C, additional, Lakey, R, additional, Riddell, V, additional, Smith, A, additional, Storey, G, additional, Munshi, S, additional, Buck, A, additional, Clarke, J, additional, Gilzeane, N, additional, Godfrey, M, additional, Keshvara, R, additional, Richardson, C, additional, Roffe, J, additional, Ryan, L, additional, Shelton, F, additional, Sunman, W, additional, Tittle, A, additional, Tomlinson, J, additional, Whittamore, K, additional, Wilkes, G, additional, Owusu-Agyei, P, additional, Temple, N, additional, Mangion, D, additional, Hardwick, A, additional, Netherton, K, additional, Nor, A Mohd, additional, Hyams, B, additional, Norman, S, additional, Persad, N, additional, Ragab, S, additional, Dickson, C, additional, Dube, J, additional, Jinks, E, additional, Knops, K, additional, Wadams, B, additional, Ali, K, additional, Gaylard, J, additional, Spurling, G, additional, Sztriha, L, additional, Ajao, T, additional, Alao, M, additional, Chan, F K, additional, Webster, P, additional, Howard, P, additional, Dobson, T J, additional, Hyatt, L, additional, Sims, D, additional, Cunningham, J, additional, Esisi, B, additional, Cassidy, T, additional, Bokhari, M, additional, McClelland, B, additional, Mokoena, B, additional, Gunathilagan, G, additional, Jones, S, additional, Reader, M, additional, Thomas, G, additional, Tilby, S, additional, Findlay, P, additional, Barrett, F, additional, Leslie, F, additional, Ross, S, additional, Shread, I, additional, Okwera, J, additional, Howe, J, additional, Harrington, F, additional, Courtauld, G, additional, Schofield, C, additional, Donnelly, R, additional, Maddula, M, additional, Scott, J, additional, Beavan, J, additional, Muhidden, K, additional, Memon, I, additional, Clarke, M, additional, Hedstrom, A, additional, Mills, L, additional, Hemsley, A, additional, Bowring, A, additional, Boxall, L, additional, Kingwell, H, additional, Keenan, S, additional, Roughan, C, additional, Manoj, A, additional, Cox, P, additional, Fletcher, G, additional, Lopez, P, additional, Emsley, H, additional, Gregary, B, additional, McLoughlin, A, additional, Raj, S, additional, Roffe, C, additional, Abano, N, additional, Barry, A, additional, Butler, A, additional, Carpio, R, additional, Castro, K, additional, Finney, K, additional, Gomm, S, additional, Hiden, J, additional, Grocott, J, additional, Lyjko, S, additional, Maguire, H, additional, Remegoso, A, additional, Sanyal, R, additional, Stevens, S, additional, Natarajan, I, additional, Chembala, J, additional, Muddegowda, G, additional, Warusevitane, A, additional, Blight, A, additional, Balazikova, O, additional, Lawlor, C, additional, Shaw, L, additional, Button, D, additional, Howcroft, D, additional, Lucas, S, additional, Madigan, B, additional, McCann, S, additional, Dixit, A, additional, Barkat, A, additional, Davis, J, additional, Fawcett, M, additional, Finlay, L, additional, Guy, H, additional, Hays, C, additional, Hogg, V, additional, Horsley, E, additional, Hubbuck, C, additional, Pringle, C, additional, Stevenson, C, additional, Storey, K, additional, Thompson, T, additional, Woodward, S, additional, Banerjee, A, additional, Allcock, C, additional, Merotra, S, additional, Douglass, C, additional, Campbell, E, additional, Jarapa, R, additional, Johnes, M, additional, Keaveney, C, additional, Marsden, T, additional, Naing, Z, additional, Perez, J, additional, Shaw, K, additional, Black, T, additional, Anthony, A, additional, Clarke, C, additional, Paterson, J, additional, Deighton, K, additional, Temlett, E, additional, Blank, C, additional, Doyle, C, additional, Duty, S, additional, Gill, K, additional, Harkness, K, additional, Kamara, C, additional, Richards, E, additional, Elfandi, K, additional, Guyler, P, additional, Harman, P, additional, Khuoge, C, additional, Kunhunny, S, additional, Tysoe, S, additional, Moynihan, B, additional, Adedoyin, T, additional, Chopra, N, additional, Dayal, N, additional, Ghatala, R, additional, Jeyaraj, N, additional, Jones, I, additional, Kennedy, F, additional, Kerin, L, additional, Khanom, N, additional, Lewis, S, additional, Maheswaran, S, additional, Montague, L, additional, Niemierko, M, additional, O'Reilly, J, additional, Trippier, S, additional, Watson, F, additional, Wilkinson, P, additional, Young, E, additional, Dizayee, K, additional, Cochrane, H, additional, O'Connell, J, additional, Mokoena, L, additional, Osborne, E, additional, Nair, A, additional, Greig, J, additional, Jenkins, C, additional, Powell, J, additional, Price, F, additional, Chowdhury, M, additional, Brixey, S, additional, Hunt, L, additional, Rands, N, additional, Rose, G, additional, Stoddart, S, additional, Srinivasan, M, additional, Motherwell, N, additional, Shekhar, R, additional, Fuller, T, additional, Lankester, A, additional, Lingwood, P, additional, Rankin, C, additional, Webb, H, additional, Jupp, B, additional, Bell, J, additional, Hann, G, additional, Longland, B, additional, Ovington, C, additional, Bhaskaran, B, additional, Ayres, G, additional, Bailey, C, additional, Bearne, H, additional, Buxton, J, additional, Fitzell, P, additional, Hilaire, C, additional, Kelly, D, additional, Szabo, S, additional, Tomlin, D, additional, Gamble, E, additional, Charles, B, additional, Kumar, R, additional, Fluskey, T, additional, Mellor, Z, additional, Peters, J, additional, Sutton, V, additional, Kenton, A, additional, Martin, I, additional, Nyabadza, S, additional, Ghosh, S, additional, Henry, M, additional, Kumar, B, additional, Ambulo, C, additional, Crawford, S, additional, Nozedar, T, additional, Platton, M, additional, Cvoro, V, additional, Couser, M, additional, McCormick, K, additional, Wilkinson, D, additional, Javaid, K, additional, Hurdowar, S, additional, Attygalle, T, additional, Sundayi, S, additional, Orugun, O, additional, Crowther, H, additional, Jolly, R, additional, Poultney, U, additional, Azim, A, additional, Krasinska-Chavez, M, additional, White, J, additional, Sengupta, N, additional, Margalef, J, additional, Metiu, M G, additional, Meenakshisundaram, S, additional, Dealing, S, additional, Hargroves, D, additional, Beranova, E, additional, Cowie, L, additional, Rudenko, H, additional, Thomson, A, additional, Verrion, A, additional, Rashed, K, additional, Board, S, additional, Buckley, C, additional, Hayward, D, additional, Jenkins, K, additional, Keeling, E, additional, Rowland-Axe, R, additional, Vickers, C, additional, Wood, D, additional, Lehman, A, additional, Patel, M, additional, Russell, H, additional, Rehman, H, additional, Forrest, D, additional, and Farren, P, additional

Published
2018
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22. Does tranexamic acid lead to changes in MRI measures of brain tissue health in patients with spontaneous intracerebral haemorrhage? Protocol for a MRI substudy nested within the double-blind randomised controlled TICH-2 trial

Author

Dineen, Rob A, primary, Pszczolkowski, Stefan, additional, Flaherty, Katie, additional, Law, Zhe K, additional, Morgan, Paul S, additional, Roberts, Ian, additional, Werring, David J, additional, Salman, Rustam Al-Shahi, additional, England, Tim, additional, Bath, Philip M, additional, and Sprigg, Nikola, additional

Published
2018
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26. Tolerability, Safety and Intermediary Pharmacological Effects of Cilostazol and Isosorbide Mononitrate, Alone and Combined, in Patients with Lacunar Ischaemic Stroke: The LACunar Intervention-1 (LACI-1) Trial

Author

Blair, Gordon W., primary, Appleton, Jason P, additional, Flaherty, Katie, additional, Doubal, Fergus, additional, Sprigg, Nikola, additional, Dooley, Richard, additional, Richardson, Carla, additional, Hamilton, Iona, additional, Law, Zhe Kang, additional, Shi, Yulu, additional, Stringer, Michael S., additional, Thrippleton, Michael J., additional, Boyd, Julia, additional, Shuler, Kirsten, additional, Bath, Philip M., additional, and Wardlaw, Joanna, additional

Published
2018
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28. Baseline characteristics of the 3096 patients recruited into the 'Triple Antiplatelets for Reducing Dependency after Ischemic Stroke' trial

Author

Bath, Philip Mw, Appleton, Jason P, Beridze, Maia, Christensen, Hanne, Dineen, Robert A, Duley, Lelia, England, Timothy J, Heptinstall, Stan, James, Marilyn, Krishnan, Kailash, Markus, Hugh S, Pocock, Stuart, Ranta, Annemarei, Robinson, Thompson G, Flaherty, Katie, Scutt, Polly, Venables, Graham S, Woodhouse, Lisa J, Sprigg, Nikola, Bath, Philip Mw, Appleton, Jason P, Beridze, Maia, Christensen, Hanne, Dineen, Robert A, Duley, Lelia, England, Timothy J, Heptinstall, Stan, James, Marilyn, Krishnan, Kailash, Markus, Hugh S, Pocock, Stuart, Ranta, Annemarei, Robinson, Thompson G, Flaherty, Katie, Scutt, Polly, Venables, Graham S, Woodhouse, Lisa J, and Sprigg, Nikola

Abstract

Background The risk of recurrence following ischemic stroke or transient ischemic attack is highest immediately after the event. Antiplatelet agents are effective in reducing the risk of recurrence and two agents are superior to one in the early phase after ictus. Design The triple antiplatelets for reducing dependency after ischemic stroke trial was an international multicenter prospective randomized open-label blinded-endpoint trial that assessed the safety and efficacy of short-term intensive antiplatelet therapy with three agents (combined aspirin, clopidogrel and dipyridamole) as compared with guideline treatment in acute ischemic stroke or transient ischemic attack. The primary outcome was stroke recurrence and its severity, measured using the modified Rankin Scale at 90 days. Secondary outcomes included recurrent vascular events, functional measures (cognition, disability, mood, quality of life), and safety (bleeding, death, serious adverse events). Data are number (%) or mean (standard deviation, SD). Results Recruitment ran from April 2009 to March 2016; 3096 patients were recruited from 106 sites in four countries (Denmark 1.6%, Georgia 2.7%, New Zealand 0.2%, UK 95.4%). Randomization characteristics included: age 69.0 (10.1) years; male 1945 (62.8%); time onset to randomization 29.4 (11.9) h; stroke severity (National Institutes for Health Stroke Scale) 2.8 (3.6); blood pressure 143.5 (18.2)/79.5 (11.4) mmHg; IS 2143 (69.2%), transient ischemic attack 953 (30.8%). Conclusion Triple antiplatelets for reducing dependency after ischemic stroke was a large trial of intensive/triple antiplatelet therapy in acute ischemic stroke and transient ischemic attack, and included participants from four predominantly Caucasian countries who were representative of patients in many western stroke services.

Published
2017

29. Preventing cognitive decline and dementia from cerebral small vessel disease: The LACI-1 Trial. Protocol and statistical analysis plan of a phase IIa dose escalation trial testing tolerability, safety and effect on intermediary endpoints of isosorbide mononitrate and cilostazol, separately and in combination

Author

Blair, Gordon W, primary, Appleton, Jason P, additional, Law, Zhe Kang, additional, Doubal, Fergus, additional, Flaherty, Katie, additional, Dooley, Richard, additional, Shuler, Kirsten, additional, Richardson, Carla, additional, Hamilton, Iona, additional, Shi, Yulu, additional, Stringer, Michael, additional, Boyd, Julia, additional, Thrippleton, Michael J, additional, Sprigg, Nikola, additional, Bath, Philip M, additional, and Wardlaw, Joanna M, additional

Published
2017
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31. Abstract WP76: Baseline Characteristics of the 3,096 Patients Recruited Into the ‘Triple Antiplatelets for Reducing Dependency After Ischaemic Stroke’ (TARDIS) Trial

Author

Bath, Philip M, primary, Appleton, Jason P, additional, Beridze, Maia, additional, Christensen, Hanne, additional, Dineen, Robert A, additional, Duley, Lelia, additional, England, Timothy J, additional, Heptinstall, Stan, additional, James, Marilyn, additional, Krishnan, Kailash, additional, Markus, Hugh S, additional, Pocock, Stuart, additional, Ranta, Annemarei, additional, Robinson, Thompson, additional, Flaherty, Katie, additional, Scutt, Polly, additional, Venables, Graham S, additional, Woodhouse, Lisa, additional, and Sprigg, Nikola, additional

Published
2017
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32. Remote Assessment of Platelet Function in Patients with Acute Stroke or Transient Ischaemic Attack

Author

Bath, Philip M., primary, May, Jane, additional, Flaherty, Katie, additional, Woodhouse, Lisa J., additional, Dovlatova, Natalia, additional, Fox, Sue C., additional, England, Timothy J., additional, Krishnan, Kailash, additional, Robinson, Thompson G., additional, Sprigg, Nikola, additional, Heptinstall, Stan, additional, and Investigators, TARDIS, additional

Published
2017
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33. Baseline characteristics of the 3096 patients recruited into the ‘Triple Antiplatelets for Reducing Dependency after Ischemic Stroke’ trial

Author

Bath, Philip MW, primary, Appleton, Jason P, additional, Beridze, Maia, additional, Christensen, Hanne, additional, Dineen, Robert A, additional, Duley, Lelia, additional, England, Timothy J, additional, Heptinstall, Stan, additional, James, Marilyn, additional, Krishnan, Kailash, additional, Markus, Hugh S, additional, Pocock, Stuart, additional, Ranta, Annemarei, additional, Robinson, Thompson G, additional, Flaherty, Katie, additional, Scutt, Polly, additional, Venables, Graham S, additional, Woodhouse, Lisa J, additional, and Sprigg, Nikola, additional

Published
2016
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34. Preventing cognitive decline and dementia from cerebral small vessel disease: The LACI-1 Trial. Protocol and statistical analysis plan of a phase IIa dose escalation trial testing tolerability, safety and effect on intermediary endpoints of isosorbide mononitrate and cilostazol, separately and in combination

Author

Blair, Gordon W., Appleton, Jason P., Law, Zhe Kang, Doubal, Fergus, Flaherty, Katie, Dooley, Richard, Shuler, Kirsten, Richardson, Carla, Hamilton, Iona, Shi, Yulu, Stringer, Michael, Boyd, Julia, Thrippleton, Michael J., Sprigg, Nikola, Bath, Philip M., and Wardlaw, Joanna M.

Subjects
LACUNAR stroke, PATHOLOGICAL physiology, DEMENTIA, ENDOTHELIUM, ARTERIAL physiology, STROKE
Abstract

Rationale The pathophysiology of most lacunar stroke, a form of small vessel disease, is thought to differ from large artery atherothrombo- or cardio-embolic stroke. Licensed drugs, isosorbide mononitrate and cilostazol, have promising mechanisms of action to support their testing to prevent stroke recurrence, cognitive impairment, or radiological progression after lacunar stroke. Aim LACI-1 will assess the tolerability, safety, and efficacy, by dose, of isosorbide mononitrate and cilostazol, alone and in combination, in patients with ischemic lacunar stroke. Sample size A sample of 60 provides 80+% power (significance 0.05) to detect a difference of 35% (90% versus 55%) between those reaching target dose on one versus both drugs. Methods and design LACI-1 is a phase IIa partial factorial, dose-escalation, prospective, randomized, open label, blinded endpoint trial. Participants are randomized to isosorbide mononitrate and/or cilostazol for 11 weeks with dose escalation to target as tolerated in two centers (Edinburgh, Nottingham). At three visits, tolerability, safety, blood pressure, pulse wave velocity, and platelet function are assessed, plus magnetic resonance imaging to assess cerebrovascular reactivity in a subgroup. Study outcomes Primary: proportion of patients completing study achieving target maximum dose. Secondary symptoms whilst taking medications; safety (hemorrhage, recurrent vascular events, falls); blood pressure, platelet function, arterial stiffness, and cerebrovascular reactivity. Discussion This study will inform the design of a larger phase III trial of isosorbide mononitrate and cilostazol in lacunar stroke, whilst providing data on the drugs’ effects on vascular and platelet function. Trial registration ISRCTN (ISRCTN12580546) and EudraCT (2015-001953-33). [ABSTRACT FROM AUTHOR]

Published
2018
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35. Baseline characteristics of the 3096 patients recruited into the 'Triple Antiplatelets for Reducing Dependency after Ischemic Stroke' trial.

Author

Bath, Philip M. W., Appleton, Jason P., Beridze, Maia, Christensen, Hanne, Dineen, Robert A., Duley, Lelia, England, Timothy J., Heptinstall, Stan, James, Marilyn, Krishnan, Kailash, Markus, Hugh S., Pocock, Stuart, Ranta, Annemarei, Robinson, Thompson G., Flaherty, Katie, Scutt, Polly, Venables, Graham S., Woodhouse, Lisa J., and Sprigg, Nikola

Subjects
MEDICAL care, BLOOD pressure, CARDIOVASCULAR system, HYPERPERFUSION, STANDARD deviations
Abstract

Background: The risk of recurrence following ischemic stroke or transient ischemic attack is highest immediately after the event. Antiplatelet agents are effective in reducing the risk of recurrence and two agents are superior to one in the early phase after ictus. Design: The triple antiplatelets for reducing dependency after ischemic stroke trial was an international multicenter prospective randomized open-label blinded-endpoint trial that assessed the safety and efficacy of short-term intensive antiplatelet therapy with three agents (combined aspirin, clopidogrel and dipyridamole) as compared with guideline treatment in acute ischemic stroke or transient ischemic attack. The primary outcome was stroke recurrence and its severity, measured using the modified Rankin Scale at 90 days. Secondary outcomes included recurrent vascular events, functional measures (cognition, disability, mood, quality of life), and safety (bleeding, death, serious adverse events). Data are number (%) or mean (standard deviation, SD). Results: Recruitment ran from April 2009 to March 2016; 3096 patients were recruited from 106 sites in four countries (Denmark 1.6%, Georgia 2.7%, New Zealand 0.2%, UK 95.4%). Randomization characteristics included: age 69.0 (10.1) years; male 1945 (62.8%); time onset to randomization 29.4 (11.9) h; stroke severity (National Institutes for Health Stroke Scale) 2.8 (3.6); blood pressure 143.5 (18.2)/79.5 (11.4) mmHg; IS 2143 (69.2%), transient ischemic attack 953 (30.8%). Conclusion: Triple antiplatelets for reducing dependency after ischemic stroke was a large trial of intensive/triple antiplatelet therapy in acute ischemic stroke and transient ischemic attack, and included participants from four predominantly Caucasian countries who were representative of patients in many western stroke services. [ABSTRACT FROM AUTHOR]

Published
2017
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36. Statistical analysis plan for the 'Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage' (TICH-2) trial.

Author

Flaherty, Katie, Bath, Philip M., Dineen, Robert, Law, Zhe, Scutt, Polly, Pocock, Stuart, Sprigg, Nikola, and TICH-2 investigators

Subjects
*ASPIRIN, *PRIMARY care, *SYNCOPE, *STATISTICAL models, *TRANEXAMIC acid
Abstract

Rationale: Aside from blood pressure lowering, treatment options for intracerebral haemorrhage remain limited and a proportion of patients will undergo early haematoma expansion with resultant significant morbidity and mortality. Tranexamic acid (TXA), an anti-fibrinolytic drug, has been shown to significantly reduce mortality in patients, who are bleeding following trauma, when given rapidly. TICH-2 is testing whether TXA is effective at improving outcome in spontaneous intracerebral haemorrhage (SICH).Methods and Design: TICH-2 is a pragmatic, phase III, prospective, double-blind, randomised placebo-controlled trial. Two thousand adult (aged ≥ 18 years) patients with an acute SICH, within 8 h of stroke onset, will be randomised to receive TXA or the placebo control. The primary outcome is ordinal shift of modified Rankin Scale score at day 90. Analyses will be performed using intention-to-treat.Results: This paper and its attached appendices describe the statistical analysis plan (SAP) for the trial and were developed and published prior to database lock and unblinding to treatment allocation. The SAP includes details of analyses to be undertaken and unpopulated tables which will be reported in the primary and key secondary publications. The database will be locked in early 2018, ready for publication of the results later in the same year.Discussion: The SAP details the analyses that will be done to avoid bias arising from prior knowledge of the study findings. The trial will determine whether TXA can improve outcome after SICH, which currently has no definitive therapy.Trial Registration: ISRCTN registry, ID: ISRCTN93732214 . Registered on 17 January 2013. [ABSTRACT FROM AUTHOR]

Published
2017
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37. We're not just turkeys

Author

Flaherty, Katie Marshall

Subjects
Poultry industry, Philosophy and religion
Abstract

An Experience of Spirit: Spirituality and Storytelling, by John Shea, (Missouri: Ligouri Publications, 2004), 239 pages. Let all who have ears to hear, hear this story. There once was a [...]

Published
2006

38. Rosalie Bertell: Scientist, Eco-Feminist, Visionary

Author

Flaherty, Katie Marshall

Subjects
Rosalie Bertell: Scientist, Eco-Feminist, Visionary (Book) -- Engels, Mary-Louise, Books -- Book reviews, Philosophy and religion
Abstract

Rosalie Bertell: Scientist, Eco-Feminist, Visionary is a bright green book in the Women Who Rock series, a catchy name for a collection of tributes to outstanding women. The opening image [...]

Published
2005

39. Millions

Author

Flaherty, Katie Marshall

Subjects
Philosophy and religion
Abstract

MILLIONS This is how I see them Like air-borne eyelashes Milkweed fluff to the air-, These are fair impulses-- Flickers of forgiveness, Fragments of praise, Flint sparks, Lost in the [...]

Published
2005

40. Dream Catchers: How Mainstream America Discovered Native Spirituality

Author

Flaherty, Katie

Subjects
Dream Catchers: How Mainstream America Discovered Native Spirituality (Book) -- Flaherty, Katie, Dream Catchers: How Mainstream America Discovered Native Spirituality (Nonfiction work) -- Book reviews, Books -- Book reviews, Philosophy and religion
Abstract

Dream Catchers: How Mainstream America Discovered Native Spirituality by Philip Jenkins, New York, Oxford University Press, 2005, 249 pp. MohawkSaint:Catherine Tekakwitha and the Jesuits by Alan Greer, New York, Oxford [...]

Published
2005

41. Hurtig challenges Canadian government

Author

Flaherty, Katie Marshall

Subjects
Rushing to Armageddon: the Shocking Truth About Canada, Missile Defence, and Star Wars (Book) -- Hurtig, Mel, Books -- Book reviews, Philosophy and religion
Abstract

Rushing to Armageddon: The Shocking Truth about Canada, Missile Defence, and Star Wars, has sat by my bedside these past few weeks. This is no cozy bedtime read. When my [...]

Published
2004

42. 8th Day

Author

Flaherty, Katie Marshall

Subjects
Philosophy and religion
Abstract

8th Day Imagine people over profit, persons over products, the juggernaut stopping to not crush an ant, holding a wrinkled hand, a stump, ramping a wheelchair on your lunch hour. [...]

Published
2004

43. Human right to peace

Author

Flaherty, Katie Marshall

Subjects
The Human Right to Peace (Book) -- Roche, Douglas, Books -- Book reviews, Philosophy and religion
Abstract

The Human Right to Peace by Douglas Roche, Ottawa, Novalis, 2003. One busy day, I was racing around trying to get too much done, and I exclaimed to my three [...]

Published
2004

44. Just being in the world

Author

Flaherty, Katie Marshall

Subjects
Teaching Places -- Whitson, Audrey, Books -- Book reviews, Philosophy and religion
Abstract

Teaching Places by Audrey Whitson, Wilfrid Laurier University Press, Waterloo, 2003, 192 pp. It seems serendipitous to me that I was given the book, Teaching Places, by Audrey Whitson to [...]

Published
2004

45. Sexuality as love energy

Author

Flaherty, Katie Marshall

Subjects
Philosophy and religion
Abstract

Tender Fire: The Spiritual Promise of Sexuality by Fran Ferder and John Heagle. New York: Crossroad, 2002. 224 pp. As you read this review, old flames are sipping wine together, [...]

Published
2003

46. Does tranexamic acid lead to changes in MRI-measures of brain tissue health in patients with spontaneous intracerebral haemorrhage? An MRI sub-study nested within the double-blind randomised controlled TICH-2 trial

Author

Dineen, Robert A., Pszczolkowski, Stefan, Flaherty, Katie, Law, Zhe Kang, Morgan, Paul S., Roberts, Ian, Werring, David, Al-Shahi Salman, Rustam, England, Timothy J., Bath, Philip M.W., and Sprigg, Nikola

Subjects
diffusion weighted imaging, magnetic resonance imaging, hyperacute primary intracerebral haemorrhage, tranexamic acid, perihaematomal oedema
Abstract

Objectives: To test whether administration of the antifibrinolytic drug tranexamic acid (TXA) in patients with spontaneous intracerebral haemorrhage (SICH) leads to increased prevalence of diffusion-weighted MRI defined hyperintense ischaemic lesions (primary hypothesis) or reduced perihaematomal oedema volume, perihaematomal diffusion restriction and residual MRI-defined SICH-related tissue damage (secondary hypotheses).Design: MRI sub-study nested within the double-blind randomised controlled TICH-2 trial (ISRCTN93732214).Setting: International multi-centre hospital-based study.Participants: Eligible adults consented and randomised in the TICH-2 trial who were also able to undergo MRI scanning. To address the primary hypothesis a sample size of n=280 will allow detection of a 10% relative increase in prevalence of diffusion weighted imaging hyperintense lesions in the TXA group with 5% significance, 80% power and 5% imaging data rejection.Interventions: TICH-2 MRI sub-study participants will undergo MRI scanning using a standardised protocol at day ~5 and day ~90 after randomisation. Clinical assessments, randomisation to TXA or placebo and participant follow-up will be performed as per the TICH-2 trial protocol.Conclusion: The TICH-2 MRI sub-study will test whether TXA increases the incidence of new DWI-defined ischemic lesions or reduces perihaematomal oedema or final ICH lesion volume in the context of SICH.

47. Statistical analysis plan for the ‘Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage’ (TICH-2) trial

Author

Flaherty, Katie, Bath, Philip M.W., Dineen, Robert, Law, Zhe, Scutt, Polly, Pocock, Stuart, and Sprigg, Nikola

Subjects
Hyperacute, Spontaneous intracerebral haemorrhage, Tranexamic acidRandomised trial, Placebo-controlled
Abstract

RationaleAside from blood pressure lowering, treatment options for intracerebral haemorrhage remain limited and a proportion of patients will undergo early haematoma expansion with resultant significant morbidity and mortality. Tranexamic acid (TXA), an anti-fibrinolytic drug, has been shown to significantly reduce mortality in patients, who are bleeding following trauma, when given rapidly. TICH-2 is testing whether TXA is effective at improving outcome in spontaneous intracerebral haemorrhage (SICH).Methods and designTICH-2 is a pragmatic, phase III, prospective, double-blind, randomised placebo-controlled trial. Two thousand adult (aged???18 years) patients with an acute SICH, within 8 h of stroke onset, will be randomised to receive TXA or the placebo control. The primary outcome is ordinal shift of modified Rankin Scale score at day 90. Analyses will be performed using intention-to-treat.ResultsThis paper and its attached appendices describe the statistical analysis plan (SAP) for the trial and were developed and published prior to database lock and unblinding to treatment allocation. The SAP includes details of analyses to be undertaken and unpopulated tables which will be reported in the primary and key secondary publications. The database will be locked in early 2018, ready for publication of the results later in the same year.DiscussionThe SAP details the analyses that will be done to avoid bias arising from prior knowledge of the study findings. The trial will determine whether TXA can improve outcome after SICH, which currently has no definitive therapy.Trial registrationISRCTN registry, ID: ISRCTN93732214. Registered on 17 January 2013.

48. Antiplatelet therapy with aspirin, clopidogrel, and dipyridamole versus clopidogrel alone or aspirin and dipyridamole in patients with acute cerebral ischaemia (TARDIS): a randomised, open-label, phase 3 superiority trial

Author

Bath, Philip M.W., Woodhouse, Lisa J., Appleton, Jason P., Beridze, M., Christensen, Hanne, Dineen, Robert A., Duley, Lelia, England, Timothy J., Flaherty, Katie, Havard, Diane, Heptinstall, Stan, James, Marilyn, Krishnan, Kailash, Markus, H.S., Montgomery, Alan A., Pocock, Stuart J., Randall, Marc, Ranta, A., Robinson, Thompson G., Scutt, Polly, Venables, Graham S., Sprigg, Nikola, Bath, Philip M.W., Woodhouse, Lisa J., Appleton, Jason P., Beridze, M., Christensen, Hanne, Dineen, Robert A., Duley, Lelia, England, Timothy J., Flaherty, Katie, Havard, Diane, Heptinstall, Stan, James, Marilyn, Krishnan, Kailash, Markus, H.S., Montgomery, Alan A., Pocock, Stuart J., Randall, Marc, Ranta, A., Robinson, Thompson G., Scutt, Polly, Venables, Graham S., and Sprigg, Nikola

Abstract

Background: Intensive antiplatelet therapy with three agents might be more effective than guideline treatment for preventing recurrent events in patients with acute cerebral ischaemia. We aimed to compare the safety and efficacy of intensive antiplatelet therapy (combined aspirin, clopidogrel, and dipyridamole) with that of guideline-based antiplatelet therapy. Methods: We did an international, prospective, randomised, open-label, blinded-endpoint trial in adult participants with ischaemic stroke or transient ischaemic attack (TIA) within 48 h of onset. Participants were assigned in a 1:1 ratio using computer randomisation to receive loading doses and then 30 days of intensive antiplatelet therapy (combined aspirin 75 mg, clopidogrel 75 mg, and dipyridamole 200 mg twice daily) or guideline-based therapy (comprising either clopidogrel alone or combined aspirin and dipyridamole). Randomisation was stratified by country and index event, and minimised with prognostic baseline factors, medication use, time to randomisation, stroke-related factors, and thrombolysis. The ordinal primary outcome was the combined incidence and severity of any recurrent stroke (ischaemic or haemorrhagic; assessed using the modified Rankin Scale) or TIA within 90 days, as assessed by central telephone follow-up with masking to treatment assignment, and analysed by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN47823388. Findings: 3096 participants (1556 in the intensive antiplatelet therapy group, 1540 in the guideline antiplatelet therapy group) were recruited from 106 hospitals in four countries between April 7, 2009, and March 18, 2016. The trial was stopped early on the recommendation of the data monitoring committee. The incidence and severity of recurrent stroke or TIA did not differ between intensive and guideline therapy (93 [6%] participants vs 105 [7%]; adjusted common odds ratio [cOR] 0·90, 95% CI 0·67–1·20, p=0·47). By contrast, intensive antipl

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49. Baseline characteristics of the 3,096 patients recruited into the 'Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke' (TARDIS) trial

Author

Bath, Philip M.W., Appleton, Jason P., Beridze, M., Christensen, Hanne, Dineen, Robert A., Duley, Lelia, England, Timothy J., Heptinstall, Stan, James, Marilyn, Krishnan, Kailash, Markus, H.S., Pocock, Stuart J., Ranta, A., Robinson, Thompson G., Flaherty, Katie, Scutt, Polly, Venables, G., Woodhouse, Lisa J., Sprigg, Nikola, Bath, Philip M.W., Appleton, Jason P., Beridze, M., Christensen, Hanne, Dineen, Robert A., Duley, Lelia, England, Timothy J., Heptinstall, Stan, James, Marilyn, Krishnan, Kailash, Markus, H.S., Pocock, Stuart J., Ranta, A., Robinson, Thompson G., Flaherty, Katie, Scutt, Polly, Venables, G., Woodhouse, Lisa J., and Sprigg, Nikola

Abstract

Background: The risk of recurrence following ischaemic stroke (IS) or transient ischaemic attack (TIA) is highest immediately after the event. Antiplatelet agents are effective in reducing the risk of recurrence and two agents are superior to one in the early phase after ictus. Design: The Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (TARDIS) trial was an international multicentre prospective randomised open-label blinded-endpoint trial that assessed the safety and efficacy of short-term intensive antiplatelet therapy with three agents (combined aspirin, clopidogrel and dipyridamole) as compared with guideline treatment in acute IS or TIA. The primary outcome was stroke recurrence and its severity, measured using the modified Rankin Scale at 90 days. Secondary outcomes included recurrent vascular events, functional measures (cognition, disability, mood, quality of life) and safety (bleeding, death, serious adverse events). Data are number (%) or mean (standard deviation, SD). Results: Recruitment ran from April 2009 to March 2016. 3,096 patients were recruited from 106 sites in 4 countries (Denmark 1.6%, Georgia 2.7%, New Zealand 0.2%, UK 95.4%). Randomisation characteristics included: age 69.0 (10.1) years; male 1945 (62.8%); time onset to randomisation 29.4 (11.9) hours; stroke severity (National Institutes for Health Stroke Scale) 2.8 (3.6); blood pressure 143.5 (18.2)/79.5 (11.4) mmHg; IS 2143 (69.2%), TIA 953 (30.8%). Conclusion: TARDIS was a large trial of intensive/triple antiplatelet therapy in acute IS and TIA, and included participants from four predominantly Caucasian countries who were representative of patients in many western stroke services.

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50. Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial

Author

Ovesen, Christian, Jakobsen, Janus Christian, Gluud, Christian, Steiner, Thorsten, Law, Zhe, Flaherty, Katie, Dineen, Robert, Bath, Philip M.W., Sprigg, Nikola, Christensen, Hanne, Ovesen, Christian, Jakobsen, Janus Christian, Gluud, Christian, Steiner, Thorsten, Law, Zhe, Flaherty, Katie, Dineen, Robert, Bath, Philip M.W., Sprigg, Nikola, and Christensen, Hanne

Abstract

Objective We present the statistical analysis plan of a prespecified Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 sub-study aiming to investigate, if tranexamic acid has a different effect in intracerebral haemorrhage patients with the spot sign on admission compared to spot sign negative patients. The TICH-2 trial recruited above 2000 participants with intracerebral haemorrhage arriving in hospital within 8 h after symptom onset. They were included irrespective of radiological signs of on-going haematoma expansion. Participants were randomised to tranexamic acid versus matching placebo. In this subgroup analysis, we will include all participants in TICH-2 with a computed tomography angiography on admission allowing adjudication of the participants’ spot sign status. Results Primary outcome will be the ability of tranexamic acid to limit absolute haematoma volume on computed tomography at 24 h (± 12 h) after randomisation among spot sign positive and spot sign negative participants, respectively. Within all outcome measures, the effect of tranexamic acid in spot sign positive/negative participants will be compared using tests of interaction. This sub-study will investigate the important clinical hypothesis that spot sign positive patients might benefit more from administration of tranexamic acid compared to spot sign negative patients.

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