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6. Effects of blood pressure and tranexamic acid in spontaneous intracerebral haemorrhage: a secondary analysis of a large randomised controlled trial

Author

Appleton, Jason Philip, primary, Law, Zhe Kang, additional, Woodhouse, Lisa Jane, additional, Al-Shahi Salman, Rustam, additional, Beridze, Maia, additional, Christensen, Hanne, additional, Dineen, Robert A, additional, Guerrero, Juan José Egea, additional, England, Timothy J, additional, Karlinski, Michal, additional, Krishnan, Kailash, additional, Laska, Ann Charlotte, additional, Lyrer, Philippe, additional, Ozturk, Serefnur, additional, Roffe, Christine, additional, Roberts, Ian, additional, Robinson, Thompson G, additional, Scutt, Polly, additional, Werring, David J, additional, Bath, Philip M, additional, and Sprigg, Nikola, additional

Published
2023
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8. The effects of blood pressure and tranexamic acid in spontaneous intracerebral haemorrhage: a secondary analysis of a large randomised controlled trial

Author

Appleton, Jason P, Law, Zhe Kang, Woodhouse, Lisa J, Al-Shahi Salman, Rustam, Beridze, Maia, Christensen, Hanne, Dineen, Robert A., Egea-Guerrero, Juan Jose, England, Timothy J., Karlinski, Michal, Krishnan, Kailash, Laska, Ann Charlotte, Lyrer, Philippe A., Ozturk, Serefnur, Roffe, Christine, Roberts, Ian S, Robinson, Thompson G, Scutt, Polly, Werring , David J, Bath, Philip M, and Sprigg, Nikola

Published
2023

11. Effects of blood pressure and tranexamic acid in spontaneous intracerebral haemorrhage: a secondary analysis of a large randomised controlled trial

Author

National Institutes of Health (US), Swiss Heart Foundation, Appleton, Jason Philip, Law, Zhe Kang, Woodhouse, Lisa Jane, Al-Shahi Salman, Rustam, Beridze, Maia, Christensen, Hanne, Dineen, Robert A., Egea-Guerrero, Juan José, England, Timothy J., Karlinski, Michal, Krishnan, Kailash, Laska, Ann Charlotte, Lyrer, Philippe, Ozturk, Serefnur, Roffe, Christine, Roberts, Ian, Robinson, Thompson G., Scutt, Polly, Werring, David J., Bath, Philip M., Sprigg, Nikola, National Institutes of Health (US), Swiss Heart Foundation, Appleton, Jason Philip, Law, Zhe Kang, Woodhouse, Lisa Jane, Al-Shahi Salman, Rustam, Beridze, Maia, Christensen, Hanne, Dineen, Robert A., Egea-Guerrero, Juan José, England, Timothy J., Karlinski, Michal, Krishnan, Kailash, Laska, Ann Charlotte, Lyrer, Philippe, Ozturk, Serefnur, Roffe, Christine, Roberts, Ian, Robinson, Thompson G., Scutt, Polly, Werring, David J., Bath, Philip M., and Sprigg, Nikola

Abstract

[Background] Tranexamic acid reduced haematoma expansion and early death, but did not improve functional outcome in the tranexamic acid for hyperacute spontaneous intracerebral haemorrhage-2 (TICH-2) trial. In a predefined subgroup, there was a statistically significant interaction between prerandomisation baseline systolic blood pressure (SBP) and the effect of tranexamic acid on functional outcome (p=0.019)., [Methods] TICH-2 was an international prospective double-blind placebo-controlled randomised trial evaluating intravenous tranexamic acid in patients with acute spontaneous intracerebral haemorrhage (ICH). Prerandomisation baseline SBP was split into predefined ≤170 and >170 mm Hg groups. The primary outcome at day 90 was the modified Rankin Scale (mRS), a measure of dependency, analysed using ordinal logistic regression. Haematoma expansion was defined as an increase in haematoma volume of >33% or >6 mL from baseline to 24 hours. Data are OR or common OR (cOR) with 95% CIs, with significance at p<0.05., [Results] Of 2325 participants in TICH-2, 1152 had baseline SBP≤170 mm Hg and were older, had larger lobar haematomas and were randomised later than 1173 with baseline SBP>170 mm Hg. Tranexamic acid was associated with a favourable shift in mRS at day 90 in those with baseline SBP≤170 mm Hg (cOR 0.73, 95% CI 0.59 to 0.91, p=0.005), but not in those with baseline SBP>170 mm Hg (cOR 1.05, 95% CI 0.85 to 1.30, p=0.63). In those with baseline SBP≤170 mm Hg, tranexamic acid reduced haematoma expansion (OR 0.62, 95% CI 0.47 to 0.82, p=0.001), but not in those with baseline SBP>170 mm Hg (OR 1.02, 95% CI 0.77 to 1.35, p=0.90)., [Conclusions] Tranexamic acid was associated with improved clinical and radiological outcomes in ICH patients with baseline SBP≤170 mm Hg. Further research is needed to establish whether certain subgroups may benefit from tranexamic acid in acute ICH., [Trial registration number] ISRCTN93732214.

Published
2023

15. Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial:Results From the TICH-2 Randomized Controlled Trial

Author

Law, Zhe Kang, Appleton, Jason P., Scutt, Polly, Roberts, Ian, Al-Shahi Salman, Rustam, England, Timothy J., Werring, David J., Robinson, Thompson, Krishnan, Kailash, Dineen, Robert A., Laska, Ann Charlotte, Lyrer, Philippe A., Egea-Guerrero, Juan Jose, Karlinski, Michal, Christensen, Hanne, Roffe, Christine, Bereczki, Daniel, Ozturk, Serefnur, Thanabalan, Jegan, Collins, Ronan, Beridze, Maia, Ciccone, Alfonso, Duley, Lelia, Shone, Angela, Bath, Philip M., Sprigg, Nikola, Law, Zhe Kang, Appleton, Jason P., Scutt, Polly, Roberts, Ian, Al-Shahi Salman, Rustam, England, Timothy J., Werring, David J., Robinson, Thompson, Krishnan, Kailash, Dineen, Robert A., Laska, Ann Charlotte, Lyrer, Philippe A., Egea-Guerrero, Juan Jose, Karlinski, Michal, Christensen, Hanne, Roffe, Christine, Bereczki, Daniel, Ozturk, Serefnur, Thanabalan, Jegan, Collins, Ronan, Beridze, Maia, Ciccone, Alfonso, Duley, Lelia, Shone, Angela, Bath, Philip M., and Sprigg, Nikola

Abstract

Background: Seeking consent rapidly in acute stroke trials is crucial as interventions are time sensitive. We explored the association between consent pathways and time to enrollment in the TICH-2 (Tranexamic Acid in Intracerebral Haemorrhage-2) randomized controlled trial. Methods: Consent was provided by patients or by a relative or an independent doctor in incapacitated patients, using a 1-stage (full written consent) or 2-stage (initial brief consent followed by full written consent post-randomization) approach. The computed tomography-to-randomization time according to consent pathways was compared using the Kruskal-Wallis test. Multivariable logistic regression was performed to identify variables associated with onset-to-randomization time of ≤3 hours. Results: Of 2325 patients, 817 (35%) gave self-consent using 1-stage (557; 68%) or 2-stage consent (260; 32%). For 1507 (65%), consent was provided by a relative (1 stage, 996 [66%]; 2 stage, 323 [21%]) or a doctor (all 2-stage, 188 [12%]). One patient did not record prerandomization consent, with written consent obtained subsequently. The median (interquartile range) computed tomography-to-randomization time was 55 (38-93) minutes for doctor consent, 55 (37-95) minutes for 2-stage patient, 69 (43-110) minutes for 2-stage relative, 75 (48-124) minutes for 1-stage patient, and 90 (56-155) minutes for 1-stage relative consents (P<0.001). Two-stage consent was associated with onset-to-randomization time of ≤3 hours compared with 1-stage consent (adjusted odds ratio, 1.9 [95% CI, 1.5-2.4]). Doctor consent increased the odds (adjusted odds ratio, 2.3 [1.5-3.5]) while relative consent reduced the odds of randomization ≤3 hours (adjusted odds ratio, 0.10 [0.03-0.34]) compared with patient consent. Only 2 of 771 patients (0.3%) in the 2-stage pathways withdrew consent when full consent was sought later. Two-stage consent process did not result in higher withdrawal rates or loss to follow-up. Conclusions: The use o

Published
2022

16. Outcomes in Antiplatelet?Associated Intracerebral Hemorrhage in the TICH?2 Randomized Controlled Trial

Author

Law, Zhe Kang, Desborough, Michael, Roberts, Ian, Al?Shahi Salman, Rustam, England, Timothy J., Werring, David J., Robinson, Thompson, Krishnan, Kailash, Dineen, Robert, Laska, Ann Charlotte, Peters, Nils, Egea?Guerrero, Juan Jose, Karlinski, Michal, Christensen, Hanne, Roffe, Christine, Bereczki, Daniel, Ozturk, Serefnur, Thanabalan, Jegan, Beridze, Maia, Bath, Philip M., and Sprigg, Nikola

Subjects
cardiovascular diseases, Cardiology and Cardiovascular Medicine
Abstract

BackgroundAntiplatelet therapy increases the risk of hematoma expansion in intracerebral hemorrhage (ICH) while the effect on functional outcome is uncertain.Methods and ResultsThis is an exploratory analysis of the TICH‐2 (Tranexamic Acid in Intracerebral Hemorrhage‐2) double‐blind, randomized, placebo‐controlled trial, which studied the efficacy of tranexamic acid in patients with spontaneous ICH within 8 hours of onset. Multivariable logistic regression and ordinal regression were performed to explore the relationship between pre‐ICH antiplatelet therapy, and 24‐hour hematoma expansion and day 90 modified Rankin Scale score, as well as the effect of tranexamic acid. Of 2325 patients, 611 (26.3%) had pre‐ICH antiplatelet therapy. They were older (mean age, 75.7 versus 66.5 years), more likely to have ischemic heart disease (25.4% versus 2.7%), ischemic stroke (36.2% versus 6.3%), intraventricular hemorrhage (40.2% versus 27.5%), and larger baseline hematoma volume (mean, 28.1 versus 22.6 mL) than the no‐antiplatelet group. Pre‐ICH antiplatelet therapy was associated with a significantly increased risk of hematoma expansion (adjusted odds ratio [OR], 1.28; 95% CI, 1.01–1.63), a shift toward unfavorable outcome in modified Rankin Scale (adjusted common OR, 1.58; 95% CI, 1.32–1.91) and a higher risk of death at day 90 (adjusted OR, 1.63; 95% CI, 1.25–2.11). Tranexamic acid reduced the risk of hematoma expansion in the overall patients with ICH (adjusted OR, 0.76; 95% CI, 0.62–0.93) and antiplatelet subgroup (adjusted OR, 0.61; 95% CI, 0.41–0.91) with no significant interaction between pre‐ICH antiplatelet therapy and tranexamic acid (P interaction=0.248).ConclusionsAntiplatelet therapy is independently associated with hematoma expansion and unfavorable functional outcome. Tranexamic acid reduced hematoma expansion regardless of prior antiplatelet therapy use.

Published
2021

17. Outcomes in antiplatelet-associated intracerebral hemorrhage in the tich-2 randomized controlled trial

Author

Law, Zhe Kang, Desborough, Michael, Roberts, Ian, Salman, Rustam Al Shahi, England, Timothy J., Werring, David J., Robinson, Thompson, Krishnan, Kailash, Dineen, Robert, Laska, Ann Charlotte, Peters, Nils, Egea-Guerrero, Juan Jose, Karlinski, Michal, Christensen, Hanne, Roffe, Christine, Bereczki, Daniel, Ozturk, Serefnur, Thanabalan, Jegan, Collins, Rónán, Beridze, Maia, Bath, Philip M., Sprigg, Nikola, Law, Zhe Kang, Desborough, Michael, Roberts, Ian, Salman, Rustam Al Shahi, England, Timothy J., Werring, David J., Robinson, Thompson, Krishnan, Kailash, Dineen, Robert, Laska, Ann Charlotte, Peters, Nils, Egea-Guerrero, Juan Jose, Karlinski, Michal, Christensen, Hanne, Roffe, Christine, Bereczki, Daniel, Ozturk, Serefnur, Thanabalan, Jegan, Collins, Rónán, Beridze, Maia, Bath, Philip M., and Sprigg, Nikola

Abstract

BACKGROUND: Antiplatelet therapy increases the risk of hematoma expansion in intracerebral hemorrhage (ICH) while the effect on functional outcome is uncertain. METHODS AND RESULTS: This is an exploratory analysis of the TICH-2 (Tranexamic Acid in Intracerebral Hemorrhage-2) double-blind, randomized, placebo-controlled trial, which studied the efficacy of tranexamic acid in patients with spontaneous ICH within 8 hours of onset. Multivariable logistic regression and ordinal regression were performed to explore the relationship between pre-ICH an-tiplatelet therapy, and 24-hour hematoma expansion and day 90 modified Rankin Scale score, as well as the effect of tranexamic acid. Of 2325 patients, 611 (26.3%) had pre-ICH antiplatelet therapy. They were older (mean age, 75.7 versus 66.5 years), more likely to have ischemic heart disease (25.4% versus 2.7%), ischemic stroke (36.2% versus 6.3%), intraventricular hemorrhage (40.2% versus 27.5%), and larger baseline hematoma volume (mean, 28.1 versus 22.6 mL) than the no-antiplatelet group. Pre-ICH antiplatelet therapy was associated with a significantly increased risk of hematoma expansion (adjusted odds ratio [OR], 1.28; 95% CI, 1.01– 1.63), a shift toward unfavorable outcome in modified Rankin Scale (adjusted common OR, 1.58; 95% CI, 1.32–1.91) and a higher risk of death at day 90 (adjusted OR, 1.63; 95% CI, 1.25–2.11). Tranexamic acid reduced the risk of hematoma expansion in the overall patients with ICH (adjusted OR, 0.76; 95% CI, 0.62–0.93) and antiplatelet subgroup (adjusted OR, 0.61; 95% CI, 0.41–0.91) with no significant interaction between pre-ICH antiplatelet therapy and tranexamic acid (P interaction=0.248). CONCLUSIONS: Antiplatelet therapy is independently associated with hematoma expansion and unfavorable functional out-come. Tranexamic acid reduced hematoma expansion regardless of prior antiplatelet therapy use. REGISTRATION: URL: https://www.isrctn.com; Unique identifier: ISRCTN93732214.

Published
2021

18. Baseline characteristics of the 4011 patients recruited into the ‘Efficacy of Nitric Oxide in Stroke’ (ENOS) trial

Author

Bath, Philip M. W., Adami, Alessandro, Bereczki, Daniel, Berge, Eivind, Beridze, Maia, Cala, Lesley, Casado, Ana, Caso, Valeria, Chang, Hui Meng, Christensen, Hanne, Collins, Ronan, Czlonkowska, Anna, Dineen, Robert A., El Etribi, Anwar, Ghani, Abdul Rahman, Gommans, John, Koumellis, Panos, Laska, Ann Charlotte, Lees, Kennedy R., Navarro, Jose, Ntaios, George, Ozturk, Serefnur, Phillips, Stephen, Pocock, Stuart, Prasad, Kameshwar, Scutt, Polly, de Silva, Asita H., Szatmari, Szabolcs, Díez-Tejedor, Exuperio, Utton, Sally, Wang, Yong-Jun, Wardlaw, Joanna M., Whynes, David, Wong, Lawrence, Woodhouse, Lisa, and Sprigg, Nikola

Published
2014
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19. Outcomes in Antiplatelet‐Associated Intracerebral Hemorrhage in the TICH‐2 Randomized Controlled Trial

Author

Law, Zhe Kang, primary, Desborough, Michael, additional, Roberts, Ian, additional, Al‐Shahi Salman, Rustam, additional, England, Timothy J., additional, Werring, David J., additional, Robinson, Thompson, additional, Krishnan, Kailash, additional, Dineen, Robert, additional, Laska, Ann Charlotte, additional, Peters, Nils, additional, Egea‐Guerrero, Juan Jose, additional, Karlinski, Michal, additional, Christensen, Hanne, additional, Roffe, Christine, additional, Bereczki, Daniel, additional, Ozturk, Serefnur, additional, Thanabalan, Jegan, additional, Collins, Rónán, additional, Beridze, Maia, additional, Bath, Philip M., additional, and Sprigg, Nikola, additional

Published
2021
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20. Incidence and predictors of early seizures in intracerebral haemorrhage and the effect of tranexamic acid

Author

Law, Zhe Kang, England, Timothy J., Mistri, Amit K., Woodhouse, Lisa J., Cala, Lesley, Dineen, Rob, Ozturk, Serefnur, Beridze, Maia, Collins, Ronan, Bath, Philip M., Sprigg, Nikola, and TICH-2 investigators

Subjects
seizures, intracerebral haemorrhage, tranexamic acid, randomised controlled trial, incidence
Abstract

Introduction: Seizures are common after intracerebral haemorrhage. Tranexamic acid increases the risk of seizures in non-intracerebral haemorrhage population but its effect on post-intracerebral haemorrhage seizures is unknown. We explored the risk factors and outcomes of seizures after intracerebral haemorrhage and if tranexamic acid increased the risk of seizures in the Tranexamic acid for IntraCerebral Haemorrhage-2 trial. Patients and methods: Seizures were reported prospectively up to day 90. Cox regression analyses were used to determine the predictors of seizures within 90 days and early seizures (≤7 days). We explored the effect of early seizures on day 90 outcomes. Results: Of 2325 patients recruited, 193 (8.3%) had seizures including 163 (84.5%) early seizures and 30 (15.5%) late seizures (>7 days). Younger age (adjusted hazard ratio (aHR) 0.98 per year increase, 95% confidence interval (CI) 0.97–0.99; p = 0.008), lobar haematoma (aHR 5.84, 95%CI 3.58–9.52; p < 0.001), higher National Institute of Health Stroke Scale (aHR 1.03, 95%CI 1.01–1.06; p = 0.014) and previous stroke (aHR 1.66, 95%CI 1.11–2.47; p = 0.013) were associated with early seizures. Tranexamic acid did not increase the risk of seizure within 90 days. Early seizures were associated with worse modified Rankin Scale (adjusted odds ratio (aOR) 1.79, 95%CI 1.12–2.86, p = 0.015) and increased risk of death (aOR 3.26, 95%CI 1.98–5.39; p < 0.001) at day 90. Discussion and conclusion: Lobar haematoma was the strongest independent predictor of early seizures after intracerebral haemorrhage. Tranexamic acid did not increase the risk of post-intracerebral haemorrhage seizures in the first 90 days. Early seizures resulted in worse functional outcome and increased risk of death.

Published
2020

21. ESO901391 Supplemental Material - Supplemental material for Incidence and predictors of early seizures in intracerebral haemorrhage and the effect of tranexamic acid

Author

Law, Zhe Kang, England, Timothy J, Mistri, Amit K, Woodhouse, Lisa J, Cala, Lesley, Dineen, Rob, Serefnur Ozturk, Beridze, Maia, Collins, Ronan, Bath, Philip M, and Sprigg, Nikola

Subjects
FOS: Clinical medicine, Cardiology, Medicine, 110904 Neurology and Neuromuscular Diseases
Abstract

Supplemental material, ESO901391 Supplemental Material for Incidence and predictors of early seizures in intracerebral haemorrhage and the effect of tranexamic acid by Zhe Kang Law, Timothy J England, Amit K Mistri, Lisa J Woodhouse, Lesley Cala, Rob Dineen, Serefnur Ozturk, Maia Beridze, Ronan Collins, Philip M Bath and Nikola Sprigg in European Stroke Journal

Published
2020
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23. 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

24. Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial

Author

Law, Zhe Kang, Appleton, Jason P., Scutt, Polly, Roberts, Ian, Al-Shahi Salman, Rustam, England, Timothy J., Werring, David J., Robinson, Thompson, Krishnan, Kailash, Dineen, Robert A., Laska, Ann Charlotte, Lyrer, Philippe A., Egea-Guerrero, Juan Jose, Karlinski, Michal, Christensen, Hanne, Roffe, Christine, Bereczki, Daniel, Ozturk, Serefnur, Thanabalan, Jegan, Collins, Ronan, Beridze, Maia, Ciccone, Alfonso, Duley, Lelia, Shone, Angela, Bath, Philip M., and Sprigg, Nikola

Published
2022
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25. Selected acute phase CSF factors in ischemic stroke: findings and prognostic value

Author

Intskirveli Nino, Shakarishvili1 Roman, Sanikidze Tamar, Beridze Maia, and Bornstein Natan M

Subjects
brain, ischemia, inflammation, oxidative stress, Neurology. Diseases of the nervous system, RC346-429
Abstract

Abstract Background Study aimed at investigation of pathogenic role and prognostic value of several selected cerebrospinal fluid acute phase factors that can reflect the severity of ischemic brain damage. Methods Ninety five acute ischemic stroke patients were investigated. Ischemic region visualized at the twenty fourth hour by conventional Magnetic Resonance Imaging. Stroke severity evaluated by National Institute Health Stroke Scale. One month outcome of disease was assessed by Barthel Index. Cerebrospinal fluid was taken at the sixth hour of stroke onset. CSF pro- and anti-inflammatory cytokines were studied by Enzyme Linked Immunosorbent Assay. Nitric Oxide and Lipoperoxide radical were measured by Electron Paramagnetic Resonance. CSF Nitrate levels were detected using the Griess reagent. Statistics performed by SPSS-11.0. Results At the sixth hour of stroke onset, cerebrospinal fluid cytokine levels were elevated in patients against controls. Severe stroke patients had increased interleukin-6 content compared to less severe strokes (P < 0.05). Cerebrospinal fluid Electron Paramagnetic Resonance signal of nitric oxide was increased in patients against controls. Severe stroke group had an elevated Electron Paramagnetic Resonance signal of lipoperoxiradical compared to less severe stroke. Cerebrospinal fluid nitrate levels in less severe stroke patients were higher than those for severe stroke and control. Positive correlation was established between the initial interleukin-6 content and ischemic lesion size as well as with National Institute Health Stroke Scale score on the seventh day. Initial interleukin-6 and nitrate levels in cerebrospinal fluid found to be significant for functional outcome of stroke at one month. Conclusion According to present study the cerebrospinal fluid contents of interleukin-6 and nitrates seem to be the most reliable prognostic factors in acute phase of ischemic stroke.

Published
2011
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26. Outcomes in Antiplatelet-Associated Intracerebral Hemorrhage in the TICH-2 Randomized Controlled Trial.

Author

Zhe Kang Law, Desborough, Michael, Roberts, Ian, Al-Shahi, Rustam, England, Timothy J., Werring, David J., Robinson, Thompson, Krishnan, Kailash, Dineen, Robert, Laska, Ann Charlotte, Peters, Nils, Egea-Guerrero, Juan Jose, Karlinski, Michal, Christensen, Hanne, Roffe, Christine, Bereczki, Daniel, Ozturk, Serefnur, Thanabalan, Jegan, Collins, Rónán, and Beridze, Maia

Published
2021
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27. 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

28. 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

29. 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

30. 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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32. 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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33. 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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34. 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

36. 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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37. 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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43. 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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49. Neuroprotective Treatment of Cerebral Infarction: An Experimental Study.

Author

Sanikidze, Tamar V., Beridze, Maia, Mitagvaria, Nodar, Bakhtadze, Sophia, and Khan, Nadeem

Abstract

We investigated the effect of the amniotic-derived peptide Plaferon-LB on cerebral tissue damage during photochemical insults in rats. Plaferon-LB (US patent number: 20070123467 A1) was extracted from the amniochorionic membrane of a human placenta and showed a relatively strong antihypoxic effect compared to other interferon. Thrombotic infarction was induced by photochemical illumination after intravenous injection of Rose Bengal. The infarct volume, cerebral tissue oxygen tension, cerebral blood flow, and capillary damage were measured in the following groups: untreated control rats, Plaferon-LB-alone rats, insult-alone rats, and insult in Plaferon-LB pretreated rats. The technique of electron paramagnetic resonance (EPR) spectroscopy was used to study free-radical metabolites in the blood and brain tissue ex vivo. Plaferon-LB alone had no effect on systemic blood pressure, cerebral blood flow, and reactive metabolites in the brains of intact animals. In the insult-alone group, a focal hemorrhage was observed in the ischemic area. The cerebral blood flow and tissue oxygen pressure declined to zero within an hour and remained at this level throughout the insult. The treatment with Plaferon-LB 0.5 hr before illumination resulted in a significant reduction of the median infarct size in the insult-alone group. The total length and percentage ratio of thrombotic vessels were significantly diminished in the infarct area. The intensity of Fe2+, Mn2+-, Mo5+-xanthinoxidase-containing complexes, and nitric oxide EPR signals was decreased, and the electron transport in the mitochondria was normalized. The results indicate a significant beneficial effect of Plaferon-LB on cerebral infarct, which is likely due to its antioxidative properties. [ABSTRACT FROM AUTHOR]

Published
2013
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