Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients

A Single Center, Randomized, Open Label, Multiple Dose, Crossover Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients With Stable Coronary Artery Disease

Assess the pharmacodynamic effect of ticagrelor vs. Clopidogrel in American Indian patients with stable coronary artery disease.

A Single Center, Randomized, Open Label, Multiple Dose, Crossover Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients With Stable Coronary Artery Disease

Inclusion Criteria:

• Documented stable CAD fulfilling any of the following, and taking 81mg ASA daily treatment:
• Females must be post menopausal for at least one year or surgically sterile for at least 6 months and negative urine pregnancy test
• Self-identified as American Indian
• Genetic Inclusion Criteria: must sign the informed consent for genetic and biological sample banking.

Exclusion Criteria:

• Any indication for oral anticoagulant or dual antiplatelet treatment
• Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers within 14 days and during study treatment and during:
• Increased bleeding risk including:
• Diabetic patients with HbAlC > 10% at screening
• Contraindication to clopidogrel, ASA, or ticagrelor - A history of alcohol and/or substance abuse that could interfere with conduct of the trial
• Patients requiring dialysis
• Patients scheduled for revascularization (e.g., PCI, CABG) during the study period
• Any acute or chronic unstable condition in the past 30 days
• Known active or recurrent hepatic disorder
• Patients who had ACS or stent placed within 12 months of screening
• History of Uric Acid nephropathy