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

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• Status: Withdrawn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: Coronary Artery Disease
• Intervention / Treatment: Behavioral: CORONARY ARTERY DISEASE AND CLOPIDOGREL: PATIENT SURVEY

• Study Type: Observational

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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	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	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	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	Subjects will also complete a survey about clopidogrel adherence as well as their knowledge and attitudes about pharmacogenomic testing.	baseline

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Aaron Aday, MD, VUMC

Study record dates

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: Coronary Artery Disease; African American; Anti Platelet
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• 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