Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine whether higher as compared with lower maintenance doses of clopidogrel can adequately improve the degree of platelet inhibition in carriers of a reduced-function CYP2C19 allele.

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

Details

• Lead Sponsor: The TIMI Study Group
• Collaborators: Bristol-Myers Squibb; Sanofi
• Treatments: Clopidogrel; Ticlopidine

Criteria

Inclusion Criteria (major):

1. Between 18 and 75 years of age, inclusive.

2. Have an indication for the use of clopidogrel defined as either spontaneous MI [hospitalized with final diagnosis of MI, excluding periprocedural or definite secondary MI (e.g., due to anemia or hypertensive emergency)] or PCI within the past 6 months.

3. Clinically stable and at least 4 weeks following the MI or PCI.

Exclusion Criteria (major):

1. Conditions that alter platelet function.

2. Conditions that increase bleeding risk.