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

March 29, 2021 updated by: Aaron Aday, Vanderbilt University Medical Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participant population will be recruited from routine care clinic/physician visits

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
African Americans with Coronary Artery Disease
African Americans with Coronary Artery Disease and currently taking clopidogrel
Behavioral: CORONARY ARTERY DISEASE AND CLOPIDOGREL: PATIENT SURVEY
Survey is a non-standardized assessment of demographics, medication compliance and reasons for non- compliance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
baseline
Platelet function
Time Frame: baseline
Platelet function will be measured using the VerifyNow-P2Y12 point-of-care assay.
baseline
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Aaron Aday, MD, VUMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 19, 2021

Primary Completion (ACTUAL)

March 19, 2021

Study Completion (ACTUAL)

March 19, 2021

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (ACTUAL)

November 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 171699

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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