Rationale, design and baseline characteristics of the effect of ticagrelor on health outcomes in diabetes mellitus patients Intervention study
File(s)RationaleDesignAndBaselineCharacteristics.pdf (1.05 MB)
Published version
Author(s)
Type
Journal Article
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 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.
Date Issued
2019-05
Date Acceptance
2019-02-19
Citation
Clinical Cardiology, 2019, 42 (5), pp.498-505
ISSN
0160-9289
Publisher
Wiley
Start Page
498
End Page
505
Journal / Book Title
Clinical Cardiology
Volume
42
Issue
5
Copyright Statement
© 2019 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/30788847
Subjects
Antiplatelet therapy
Clinical trials
Diabetes mellitus
General clinical cardiology/adult
Ischemic heart disease
Publication Status
Published
Coverage Spatial
United States
Date Publish Online
2019-02-20