Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rapid City Regional Hospital, Inc
• Collaborator: AstraZeneca
• Treatments: Clopidogrel; Platelet Aggregation Inhibitors; Purinergic P2 Receptor Antagonists; Purinergic P2Y Receptor Antagonists; Ticagrelor; Ticlopidine

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