A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor Twice Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients With Type 2 Diabetes Mellitus (THEMIS - Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study).
Description
Brief Summary
The purpose of this study is to compare the effect of ticagrelor versus placebo in patients
with Type 2 Diabetes Mellitus.
Detailed Description
A multinational, randomised, double-blind, placebo-controlled phase IIIb trial to evaluate
the effect of ticagrelor twice daily on the incidence of cardiovascular death, myocardial
infarction or stroke in patients with type 2 diabetes mellitus
Phase
Phase 2/3 - for trials that are a combination of phases 2 and 3.Inclusion and Exclusion Criteria
- Men or women ≥50 years of age with type 2 diabetes mellitus on treatment with a glucose lowering medication since at least 6 months, and either documented coronary artery occlusive disease or previous revascularization of a coronary artery. Key
- History of myocardial infarction or any stroke; planned treatment with agents inhibiting blood clotting; planned use of ASA/Aspirin at doses above 150 mg daily; planned coronary, cerebrovascular, or peripheral arterial revascularization; patients with known bleeding disorders and patients who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin; history of intracranial bleeding at any time, or a history of bleeding from the gastrointestinal tract within the last 6 months or a major surgery within the last 30 days; patients with known severe liver disease or with kidney failure requiring dialysis
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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