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
  Purpose

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.


Condition Intervention
Acute Coronary Syndrome
Other: Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: African-American Pharmacogenetics

Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: November 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
African-American on clopidogrel 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 prasugrel 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.
Caucasian on clopidogrel 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.
Caucasian on prasugrel 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408121

Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Research Institute
Investigators
Principal Investigator: Ron Waksman, MD Medstar Research Institute
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT01408121     History of Changes
Other Study ID Numbers: AA Genetic
Study First Received: July 29, 2011
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medstar Research Institute:
Platelet reactivity
Genotyping

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014