Overview

This trial is active, not recruiting.

Conditions myocardial infarction, percutaneous coronary intervention
Treatment clopidogrel
Phase phase 2
Sponsor The TIMI Study Group
Collaborator Bristol-Myers Squibb
Start date October 2010
End date October 2011
Trial size 275 participants
Trial identifier NCT01235351, TIMI 56

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
clopidogrel
Clopidogrel 75 mg daily, 150 mg daily, 225 mg daily, and 300 mg daily based on genotype
(Experimental)
clopidogrel
Clopidogrel 75 mg daily, 150 mg daily, 225 mg daily, and 300 mg daily based on genotype
(Experimental)
clopidogrel
Clopidogrel 75 mg daily, 150 mg daily, 225 mg daily, and 300 mg daily based on genotype
(Experimental)
clopidogrel
Clopidogrel 75 mg daily, 150 mg daily, 225 mg daily, and 300 mg daily based on genotype

Primary Outcomes

Measure
Change in measurements of platelet inhibition
time frame: Approximately every 2 weeks for 8 weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by The TIMI Study Group.