Status:
UNKNOWN
African-American Pharmacogenetics
Lead Sponsor:
Medstar Health Research Institute
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
This is a genetic and platelet reactivity study of African-American versus Caucasian patients undergoing percutaneous coronary intervention and receiving clopidogrel or prasugrel. The investigators ai...
Detailed Description
The investigators propose a pharmacogenetic cohort study of 100 African-American versus 100 Caucasian patients presenting with an acute coronary syndrome, receiving clopidogrel or prasugrel and underg...
Eligibility Criteria
Inclusion
- Patients age 18 or older, of both genders
- Presenting with an ACS, defined as at least two of the following:
- symptoms consistent with myocardial ischemia;
- ST segment elevation or depression of at least 1 mm in 2 or more contiguous leads on EKG;
- a cardiac troponin I level above upper limit of normal.
- Self-reported African-american or Caucasian race
- a. all 4 grandparents of same race
- No contraindications to prasugrel therapy.
- Patient is scheduled for, or has already undergone, PCI.
Exclusion
- Known allergies to aspirin, clopidogrel, or prasugrel.
- Patient known to be pregnant or lactating.
- Patient with known history of bleeding diathesis or currently active bleeding.
- Platelet count \<100,000/mm at the time of enrollment.
- Hematocrit \<25% at the time of enrollment.
- On warfarin therapy at the time of PCI, or patient likely to require warfarin therapy post-PCI.
- Received fibrinolytics within the past 48 hours.
- Received a glycoprotein IIb/IIIa inhibitor within the past 48 hours, or if such a strategy for PCI involving a glycoprotein IIb/IIIa inhibitor is planned.
- Taking maintenance thienopyridine therapy in the previous 5 days.
- Known blood transfusion within the preceding 10 days.
- Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.
- Patients with known chronic liver disease.
- Age greater than 75 years
- Body weight less than 60 kg
- History of stroke or transient ischemic attack
- Surgery planned within 1 month
- Patient likely to require coronary artery bypass grafting
- Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01408121
Start Date
November 1 2011
End Date
June 1 2016
Last Update
August 11 2014
Active Locations (1)
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1
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010