Clopidogrel Pharmacogenomics Project

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Loss-of-function mutation of the gene encoding the CYP450 2C19 enzyme has emerged as a likely determinant of resistance to clopidogrel therapy. The primary hypothesis of the proposed research is that among patients with confirmed loss-of-function alleles of the CYP2C19 gene, increasing the maintenance clopidogrel dose from 75 to 150 mg will result in significant reduction in the rate of measured clopidogrel resistance defined by multiple measures of platelet function

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Treatments: Clopidogrel; Ticlopidine

Criteria

Inclusion Criteria:• Currently taking clopidogrel 75 mg/day and aspirin (minimum 81 mg/day) with an indication for chronic dual antiplatelet therapy (>90 days)

• No evidence of acute coronary syndrome within 30 days of enrollment, defined by elevation of Troponin I above the upper limit of normal

• Coronary atherosclerosis documented on previous coronary angiogram

• No known contraindications to combination therapy with aspirin and clopidogrel

• Prognosis for survival greater than one year based on physician's assessment

• Able to attend all scheduled visits.

• Access to phone

• Subject is a female with a negative urine or serum pregnancy test or post-menopausal for at least 1 year prior to randomization. Females of childbearing potential must be practicing adequate birth control to be eligible. It is the Investigator's responsibility for determining whether the Subject has adequate birth control for study participation

Exclusion Criteria:• Recent acute coronary syndrome (<30 days)

• Recent hospitalization or physician visit for bleeding disorder(<90 days) or history of chronic blood loss

• Recent blood transfusion (<90 days)

• Any contraindication to aspirin or clopidogrel therapy

• Acute Febrile illness at the time of enrollment

• Subject is pregnant or lactating or planning to become pregnant