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Rationale, design and baseline characteristics of the effect of ticagrelor on health outcomes in diabetes mellitus patients Intervention study

Authors :
Bhatt, Deepak L.
Fox, Kim
Harrington, Robert A.
Leiter, Lawrence A.
Mehta, Shamir R.
Simon, Tabassome
Andersson, Marielle
Himmelmann, Anders
Ridderstrale, Wilhelm
Held, Claes
Steg, Philippe Gabriel
Steg, Gabriel
Diaz, Rafael
Amerena, John
Huber, Kurt
Sinnaeve, Peter
Nicolau, Jose Carlos
Kerr Saraiva, Jose Francisco
Petrov, Ivo
Corbalan, Ramon
Ge, Junbo
Zhao, Qiang
Botero, Rodrigo
Widimsky, Petr
Kristensen, Steen Dalby
Hartikainen, Juha
Danchin, Nicolas
Darius, Harald
Fat, Tse Hung
Kiss, Robert Gabor
Pais, Prem
Lev, Eli
De Luca, Leonardo
Goto, Shinya
Ramos Lopez, Gabriel Arturo
Cornel, Jan Hein
Kontny, Frederic
Medina, Felix
Babilonia, Noe
Opolski, Grzegorz
Vinereanu, Dragos
Zateyshchikov, Dmitry
Ruda, Mikhail
Elamin, Omer
Kovar, Frantisek
Dalby, Anthony John
Jeong, Myung Ho
Bueno, Hector
James, Stefan
Chiang, Chern-En
Tresukosol, Damras
Ongen, Zeki
Ray, Kausik
Parkhomenko, Alexander
McGuire, Darren
Kosiborod, Mikhail
Nguyen, Tuan Quang
Wallentin, Lars
Fox, Keith A. A.
Eikelboom, John W.
Tuomilehto, Jaakko
Lee, Kerry L.
Al-Khalidi, Hussein R.
Ellis, Stephen J.
Hagström, Emil
Holmgren, Pernilla
Heldestad, Ulrika
Hallberg, Theresa
Renlund Grausne, Karin
Alm, Cristina
Michelgård Palmquist, Åsa
Svanberg, Camilla
Capell, Warren H.
Nehler, Mark R.
Hiatt, William R.
Bonaca, Marc P.
Houser, Stacey
Bachler, Susie
Jaeger, Nicole
Aunes, Maria
Brusehed, Asa
Chen, Jersey
Dahlof, Bjorn
Dolezalova, Jitka
Domzol, Maciej
Findley, Magdalena
Holmberg, Niclas
Jahreskog, Marianne
Knutsson, Mikael
Kruszewski, Jakub
Leonsson-Zachrisson, Maria
Stark, Maj
Winder, Elin
Sinnaeve, P
Source :
Clinical Cardiology, 42, 498-505, Clinical Cardiology, Bhatt, D L, Fox, K, Harrington, R A, Leiter, L A, Mehta, S R, Simon, T, Andersson, M, Himmelmann, A, Ridderstråle, W, Held, C, Steg, P G & THEMIS Steering Committee 2019, ' Rationale, design and baseline characteristics of the effect of ticagrelor on health outcomes in diabetes mellitus patients Intervention study ', Clinical Cardiology, vol. 42, no. 5, pp. 498-505 . https://doi.org/10.1002/clc.23164, Clinical Cardiology, 42, 5, pp. 498-505
Publication Year :
2019

Abstract

In the setting of prior myocardial infarction, the oral antiplatelet ticagrelor added to aspirin reduced the risk of recurrent ischemic events, especially, in those with diabetes mellitus. Patients with stable coronary disease and diabetes are also at elevated risk and might benefit from dual antiplatelet therapy. The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS, NCT01991795) is a Phase 3b randomized, double-blinded, placebo-controlled trial of ticagrelor vs placebo, on top of low dose aspirin. Patients ≥50 years with type 2 diabetes receiving anti-diabetic medications for at least 6 months with stable coronary artery disease as determined by a history of previous percutaneous coronary intervention, bypass grafting, or angiographic stenosis of ≥50% of at least one coronary artery were enrolled. Patients with known prior myocardial infarction (MI) or stroke were excluded. The primary efficacy endpoint is a composite of cardiovascular death, myocardial infarction, or stroke. The primary safety endpoint is Thrombolysis in Myocardial Infarction major bleeding. A total of 19 220 patients worldwide have been randomized and at least 1385 adjudicated primary efficacy endpoint events are expected to be available for analysis, with an expected average follow-up of 40 months (maximum 58 months). Most of the exposure is on a 60 mg twice daily dose, as the dose was lowered from 90 mg twice daily partway into the study. The results may revise the boundaries of efficacy for dual antiplatelet therapy and whether it has a role outside acute coronary syndromes, prior myocardial infarction, or percutaneous coronary intervention. ispartof: CLINICAL CARDIOLOGY vol:42 issue:5 pages:498-505 ispartof: location:United States status: published

Subjects

Subjects :
Male
Ticagrelor
Cardiac & Cardiovascular Systems
Time Factors
medicine.medical_treatment
Vascular damage Radboud Institute for Health Sciences [Radboudumc 16]
Myocardial Infarction
general clinical cardiology/adult
Coronary Artery Disease
Type 2 diabetes
030204 cardiovascular system & hematology
Stroke/mortality
antiplatelet therapy
Hypoglycemic Agents/adverse effects
Coronary artery disease
DOUBLE-BLIND
0302 clinical medicine
Risk Factors
ARTERY-DISEASE
Medicine
Cardiac and Cardiovascular Systems
030212 general & internal medicine
Myocardial infarction
1102 Cardiorespiratory Medicine and Haematology
Stroke
Randomized Controlled Trials as Topic
Aspirin
Kardiologi
adult
general clinical cardiology
60 MG
Ticagrelor/administration & dosage
General Medicine
Middle Aged
Clopidogrel
Treatment Outcome
CLOPIDOGREL
diabetes mellitus
Cardiology
PLATELET INHIBITION
Drug Therapy, Combination
Female
Cardiology and Cardiovascular Medicine
Life Sciences & Biomedicine
medicine.drug
medicine.medical_specialty
Trial Designs
03 medical and health sciences
Diabetes Mellitus, Type 2/diagnosis
Double-Blind Method
Internal medicine
Humans
Hypoglycemic Agents
CARDIOVASCULAR EVENTS
Aspirin/administration & dosage
Myocardial Infarction/mortality
Platelet Aggregation Inhibitors/administration & dosage
Aged
clinical trials
Science & Technology
business.industry
ACUTE CORONARY SYNDROMES
Percutaneous coronary intervention
medicine.disease
ischemic heart disease
ASPIRIN
MYOCARDIAL-INFARCTION
Cardiovascular System & Hematology
Clinical Trials, Phase III as Topic
Diabetes Mellitus, Type 2
Cardiovascular System & Cardiology
Coronary Artery Disease/diagnosis
business
THEMIS Steering Committee
Platelet Aggregation Inhibitors

Details

ISSN :
01991795 and 01609289
Database :
OpenAIRE
Journal :
Clinical Cardiology, 42, 498-505, Clinical Cardiology, Bhatt, D L, Fox, K, Harrington, R A, Leiter, L A, Mehta, S R, Simon, T, Andersson, M, Himmelmann, A, Ridderstråle, W, Held, C, Steg, P G & THEMIS Steering Committee 2019, ' Rationale, design and baseline characteristics of the effect of ticagrelor on health outcomes in diabetes mellitus patients Intervention study ', Clinical Cardiology, vol. 42, no. 5, pp. 498-505 . https://doi.org/10.1002/clc.23164, Clinical Cardiology, 42, 5, pp. 498-505
Accession number :
edsair.doi.dedup.....22afbc11ee58ea1c6a2574fd1cb7285b