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Clin Cardiol. 2019 May;42(5):498-505. doi: 10.1002/clc.23164. Epub 2019 Apr 9.

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

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Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School Boston, Boston, Massachusetts.
National Heart and Lung Institute, Imperial College and Royal Brompton Hospital, London, UK.
Stanford Center for Clinical Research (SCCR), Department of Medicine, Stanford University, Stanford, California.
Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.
AP-HP, Hôpital Saint Antoine, Department of Clinical Pharmacology-URCEST, Sorbonne-Université Paris, Paris, France.
AstraZeneca Gothenburg, Department of Cardiovascular, Renal and Metabolism, Mölndal, Sweden.
Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
FACT (French Alliance for Cardiovascular Trials), an F-CRIN Network, Département Hospitalo-Universitaire FIRE, AP-HP, Hôpital Bichat, Université Paris-Diderot, Paris, France.
Département Hospitalo-Universitaire FIRE, AP-HP, Hôpital Bichat,Université Paris-Diderot, INSERM U-1148, Paris, France.
National Heart & Lung Institute NHLI, Imperial College, Royal Brompton Hospital, London, UK.


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.


antiplatelet therapy; clinical trials; diabetes mellitus; general clinical cardiology/adult; ischemic heart disease

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