African-American Pharmacogenetics

Status unconfirmed

Conditions studied: Acute Coronary Syndrome

In brief

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 aim is twofold: to describe differences in allele frequencies between African-Americans and Caucasians, and to explore associations of platelet reactivity and genetic polymorphisms in these two groups.

Key facts

Study ID

NCT01408121

Run by

Medstar Health Research Institute

People needed

200

Starts

2011-11-01

Expected to finish

2016-06-01

Last updated by the study team

2014-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Washington Hospital Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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