A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus



Status:Completed
Conditions:Cardiology, Diabetes, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:50 - 127
Updated:2/17/2019
Start Date:February 10, 2014
End Date:January 25, 2019

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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)

The purpose of this study is to compare the effect of ticagrelor versus placebo in patients
with Type 2 Diabetes Mellitus.

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

Inclusion 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 Exclusion Criteria:

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
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