Ticagrelor With and Without Aspirin in Patients With Diabetes Mellitus

Inclusion criteria

For inclusion in the study patients should fulfill the following criteria:

• Provision of informed consent prior to any study specific procedures
• Men or women ≥18 years of age
• Diagnosed with type 2 DM defined by ongoing glucose lowering therapy (oral medications and/or insulin) treatment for at least 1 month
• Known angiographically defined CAD (including a history of previous PCI, CABG, or >50% stenosis in a major epicardial vessel) on standard of care antiplatelet therapy* *Patients can be treated with any background antiplatelet treatment regimen as part of their standard of care, including aspirin and/or any P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel).

Exclusion criteria

• PCI 40 mg daily or lovastatin at doses >40 mg daily
• Anticipated concomitant oral or intravenous therapry of strong CYP3A inducers (phenytoin, rifampin, phenobarb, carbamazepine)
• Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin (at venous thrombosis treatment not prophylaxis doses)
• Patients with known bleeding diathesis or coagulation disorder
• History of previous intracerebral bleed at any time, gastrointestinal (GI) bleed within the past 6 months prior to randomization, or major surgery within 30 days prior to randomization
• Active pathological bleeding
• Hypersensitivity to aspirin, ticagrelor or clopidogrel
• Increased risk of bradycardic events (eg, known sick sinus syndrome, second or third degree AV block or previous documented syncope suspected to be due to bradycardia) unless treated with a pacemaker
• Known severe liver disease
• Renal failure requiring dialysis
• Known platelet count <80x106/mL
• Known hemoglobin <9 g/dL
• Pregnant or breastfeeding women. *Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.