Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56
This trial is active, not recruiting.
|Conditions||myocardial infarction, percutaneous coronary intervention|
|Sponsor||The TIMI Study Group|
|Start date||October 2010|
|End date||October 2011|
|Trial size||275 participants|
|Trial identifier||NCT01235351, TIMI 56|
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.
|Intervention model||crossover assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Change in measurements of platelet inhibition
time frame: Approximately every 2 weeks for 8 weeks
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.
|Official title||Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56|
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