Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Clopidogrel, Ticagrelor, Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases, Platelet Aggregation Inhibitors, Hematologic Agents, Therapeutic Uses, Pharmacologic Actions, Purinergic P2Y Receptor Antagonists, Purinergic P2 Receptor Antagonists, Purinergic Antagonists, Purinergic Agents, Physiological Effects of Drugs
Eligibility Criteria
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
Sites / Locations
- Regional Heart Doctors/Black Hills Cardiovascular Research
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Ticagrelor
Clopidogrel
Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days
Clopidogrel 600 mg Loading Dose followed by 75 mg Daily for 7 days ± 2 days