Ticagrelor With and Without Aspirin in Patients With Diabetes Mellitus

Prior treatment

• PCI \< 6 months prior
• Anticipated concomitant oral or intravenous therapy with strong cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 substrates with narrow therapeutic indices that cannot be stopped for the course of the study:
  • Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir
  • CYP3A4 substrates with narrow therapeutic index: quinidine, simvastatin at doses \>40 mg daily or lovastatin at doses \>40 mg daily
• Anticipated concomitant oral or intravenous therapry of strong CYP3A inducers (phenytoin, rifampin, phenobarb, carbamazepine)
• 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
• 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

Other illness

• Recent (\< 6 months) type I myocardial infarction
• 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
• Active pathological bleeding
• Hypersensitivity to aspirin, ticagrelor or clopidogrel
• Known severe liver disease
• Renal failure requiring dialysis

Lab values

• Known platelet count \<80x106/mL
• Known hemoglobin \<9 g/dL

Age

• Pregnant or breastfeeding women. \*Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.

• 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).