African-American Pharmacogenetics

NCT ID: NCT01408121

Last Updated: 2014-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2016-06-30

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 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.

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 undergoing PCI. The study will have four arms: African-American on clopidogrel; African-American on prasugrel; Caucasian on clopidogrel; and Caucasian on prasugrel. All patients will undergo genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay, at least 6 hours after receiving a thienopyridine loading dose, but before hospital discharge. All patients will be treated with aspirin 325 mg/day as well.

Race determination will be based on a patient's self-report, but patients enrolled in the trial must also report that all four of their grandparents were of the same race as theirs. Other races (Asian, Native American, et al) will be excluded from this study.

Conditions

Acute Coronary Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

African-American on clopidogrel

Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay

Intervention Type: OTHER

All patients will undergo genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay, at least 6 hours after receiving a thienopyridine loading dose but before hospital discharge.

African-American on prasugrel

Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay

Intervention Type: OTHER

All patients will undergo genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay, at least 6 hours after receiving a thienopyridine loading dose but before hospital discharge.

Caucasian on clopidogrel

Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay

Intervention Type: OTHER

All patients will undergo genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay, at least 6 hours after receiving a thienopyridine loading dose but before hospital discharge.

Caucasian on prasugrel

Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay

Intervention Type: OTHER

All patients will undergo genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay, at least 6 hours after receiving a thienopyridine loading dose but before hospital discharge.

Interventions

Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay

All patients will undergo genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay, at least 6 hours after receiving a thienopyridine loading dose but before hospital discharge.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients age 18 or older, of both genders

2. 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.

3. Self-reported African-american or Caucasian race

a. all 4 grandparents of same race

4. No contraindications to prasugrel therapy.

5. Patient is scheduled for, or has already undergone, PCI.

Exclusion Criteria

1. Known allergies to aspirin, clopidogrel, or prasugrel.

2. Patient known to be pregnant or lactating.

3. Patient with known history of bleeding diathesis or currently active bleeding.

4. Platelet count <100,000/mm at the time of enrollment.

5. Hematocrit <25% at the time of enrollment.

6. On warfarin therapy at the time of PCI, or patient likely to require warfarin therapy post-PCI.

7. Received fibrinolytics within the past 48 hours.

8. 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.

9. Taking maintenance thienopyridine therapy in the previous 5 days.

10. Known blood transfusion within the preceding 10 days.

11. Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.

12. Patients with known chronic liver disease.

13. Age greater than 75 years

14. Body weight less than 60 kg

15. History of stroke or transient ischemic attack

16. Surgery planned within 1 month

17. Patient likely to require coronary artery bypass grafting

18. Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ron Waksman, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

Washington Hospital Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

AA Genetic

Identifier Type: -

Identifier Source: org_study_id