Causes of Health Disparities in African Americans With Coronary Artery Disease on Clopidogrel

Overview

African Americans with coronary artery disease who have been prescribed clopidogrel (also known as Plavix), an antiplatelet drug will be enrolled. The purpose of this study is to help identify why African Americans are at an increased risk of having a major heart attack or stroke after a common procedure to open up blocked arteries with stents. The knowledge to be gained from this study includes: 1. A better understanding of the metabolism of the antiplatelet drug, clopidogrel, and abnormal platelet function in African Americans; this understanding may provide a basis for potential future therapy 2. A better understanding of challenges to taking clopidogrel as prescribed by a doctor and opinions about a genetic test related to this medicine.

Full Title of Study: “Investigation of the Causes of Health Disparities in African Americans With Coronary Artery Disease on Clopidogrel”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: March 19, 2021

Interventions

  • Behavioral: CORONARY ARTERY DISEASE AND CLOPIDOGREL: PATIENT SURVEY
    • Survey is a non-standardized assessment of demographics, medication compliance and reasons for non- compliance.

Arms, Groups and Cohorts

  • African Americans with Coronary Artery Disease
    • African Americans with Coronary Artery Disease and currently taking clopidogrel

Clinical Trial Outcome Measures

Primary Measures

  • Participant Adherence to Plavix as Measured by Clopidogrel Metabolites in Plasma
    • Time Frame: baseline
    • Participant adherence to Plavix as measured by clopidogrel metabolite in plasma by liquid chromatography-tandem mass spectrometry. Clopidogrel non-adherence will be defined as plasma concentration of inactive carboxyl metabolite <5,000 ng/mL.
  • Clopidogrel resistance
    • Time Frame: baseline
    • Participant resistance to Plavix as measured by DNA analysis will be conducted to determine CYP2C19*2 loss of function (LOF) status. In addition, platelet function will be measured using the VerifyNow-P2Y12 point-of-care assay.
  • Platelet function
    • Time Frame: baseline
    • Platelet function will be measured using the VerifyNow-P2Y12 point-of-care assay.
  • Patient-level barriers to implementation of routine pharmacogenomic testing for antiplatelet therapy
    • Time Frame: baseline
    • Subjects will also complete a survey about clopidogrel adherence as well as their knowledge and attitudes about pharmacogenomic testing.

Participating in This Clinical Trial

Inclusion Criteria

1. 18 years of age or older 2. Sex: Male and Female 3. Race: Self-identified as African American 4. History of percutaneous coronary intervention in the past 12 months 5. Currently taking aspirin and clopidogrel for at least one month and up to one year 6. English speaking Exclusion Criteria:

1. Use of nonsteroidal anti-inflammatory drugs 2. Pregnancy will be excluded in women of child-bearing potential using urine pregnancy test

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Aaron Aday, Instructor in Medicine Division of Cardiovascular Medicine – Vanderbilt University Medical Center
  • Overall Official(s)
    • Aaron Aday, MD, Principal Investigator, VUMC

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