Rationale, Design, and Baseline Characteristics of THEMIS: Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study. Clinical cardiology Bhatt, D. L., Fox, K., Harrington, R. A., Leiter, L. A., Mehta, S. R., Simon, T., Andersson, M., Himmelmann, A., Ridderstrale, W., Held, C., Steg, P. G., THEMIS Steering Committee 2019


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 versus placebo, on top of low dose aspirin. Patients = 50 years with type 2 diabetes receiving anti-diabetic medications for at least six 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 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 part-way 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. This article is protected by copyright. All rights reserved.

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