NCT01408121

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 11, 2014

Status Verified

August 1, 2014

Enrollment Period

4.6 years

First QC Date

July 29, 2011

Last Update Submit

August 8, 2014

Conditions

Acute Coronary Syndrome

Keywords

Platelet reactivityGenotyping

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Platelet reactivity

    During hospital stay; average hospital stay is less than 48 hours

Study Arms (4)

African-American on clopidogrel

Other: Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay

African-American on prasugrel

Other: Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay

Caucasian on clopidogrel

Other: Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay

Caucasian on prasugrel

Other: Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay

Interventions

Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assayOTHER

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 clopidogrelAfrican-American on prasugrelCaucasian on clopidogrelCaucasian on prasugrel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Genotype

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

  • Ron Waksman, MD

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2011

First Posted

August 3, 2011

Study Start

November 1, 2011

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 11, 2014

Record last verified: 2014-08

Locations

US(1)