Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients

Completed · Phase 4

Conditions studied: Coronary Artery Disease

In brief

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

Key facts

Study ID

NCT01706510

Run by

Rapid City Regional Hospital, Inc

People needed

28

Starts

2012-12-01

Expected to finish

2014-04-01

Last updated by the study team

2015-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Regional Heart Doctors/Black Hills Cardiovascular Research — Rapid City, South Dakota, United States

Full record on ClinicalTrials.gov

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