African-American Pharmacogenetics (AA Genetic)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01408121
First received: July 29, 2011
Last updated: August 8, 2014
Last verified: August 2014

July 29, 2011
August 8, 2014
November 2011
June 2016   (final data collection date for primary outcome measure)
Distribution of CYP polymorphisms [ Time Frame: During hospital stay; average hospital stay is less than 48 hours ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01408121 on ClinicalTrials.gov Archive Site
Platelet reactivity [ Time Frame: During hospital stay; average hospital stay is less than 48 hours ] [ Designated as safety issue: No ]
The secondary exploratory objective is to assess for associations between "poor metabolizer" CYP genotypes and the levels of post-thienopyridine platelet reactivity.
Same as current
Not Provided
Not Provided
 
African-American Pharmacogenetics
African-American Pharmacogenetics

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

African-american versus Caucasian patients undergoing percutaneous coronary intervention and receiving clopidogrel or prasugrel.

Acute Coronary Syndrome
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.
  • African-American on clopidogrel
    Intervention: Other: Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay
  • African-American on prasugrel
    Intervention: Other: Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay
  • Caucasian on clopidogrel
    Intervention: Other: Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay
  • Caucasian on prasugrel
    Intervention: Other: Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
June 2016
June 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01408121
AA Genetic
No
Medstar Research Institute
Medstar Research Institute
Not Provided
Principal Investigator: Ron Waksman, MD Medstar Research Institute
Medstar Research Institute
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP