Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients

Rapid City Regional Hospital, Inc

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Ticagrelor; Drug: Clopidogrel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01706510

ISSBRIL0076

Details and patient eligibility

About

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

Full description

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

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Ticagrelor

Experimental group

Description:

Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days

Treatment:

Drug: Clopidogrel

Drug: Ticagrelor

Clopidogrel

Active Comparator group

Description:

Clopidogrel 600 mg Loading Dose followed by 75 mg Daily for 7 days ± 2 days

Treatment:

Drug: Clopidogrel

Drug: Ticagrelor