A Study Comparing Cardiovascular Effects 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