African-American Pharmacogenetics

Acute Coronary Syndrome Clinical Trial

— AA Genetic  

Official title:

African-American Pharmacogenetics

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01408121
• Other study ID #: AA Genetic
• Status: Active, not recruiting
• Phase: N/A
• First received: July 29, 2011
• Last updated: August 8, 2014
• Start date: November 2011
• Est. completion date: June 2016

Study information

• Verified date: August 2014
• Source: Medstar Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of CYP polymorphisms	CYP polymorphisms will be classified by their known effects upon enzyme function, using the consensus star-allele nomenclature. More specifically, patients will be classified as a "poor metabolizer" if they possess at least one CYP allele known to be associated with reduced function of that particular CYP enzyme. Allele frequencies will then be compared between African-american and Caucasian patients.	During hospital stay; average hospital stay is less than 48 hours	No
Secondary	Platelet reactivity	The secondary exploratory objective is to assess for associations between "poor metabolizer" CYP genotypes and the levels of post-thienopyridine platelet reactivity.	During hospital stay; average hospital stay is less than 48 hours	No