Status:
COMPLETED
Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56
Lead Sponsor:
The TIMI Study Group
Collaborating Sponsors:
Bristol-Myers Squibb
Sanofi
Conditions:
Myocardial Infarction
Percutaneous Coronary Intervention
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Detailed Description
Clopidogrel blocks the P2Y12 ADP receptor on platelets and has been shown to reduce cardiovascular events in acute coronary syndrome (ACS) patients.However, inter-patient variability in the pharmacody...
Eligibility Criteria
Inclusion
- Inclusion Criteria (major):
- Between 18 and 75 years of age, inclusive.
- 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.
- Clinically stable and at least 4 weeks following the MI or PCI.
- Exclusion Criteria (major):
- Conditions that alter platelet function.
- Conditions that increase bleeding risk.
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT01235351
Start Date
October 1 2010
End Date
September 1 2011
Last Update
November 15 2019
Active Locations (1)
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1
TIMI Study Group
Boston, Massachusetts, United States, 02115