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

Withdrawn

• Conditions: Coronary Artery Disease

• Registration Number: NCT04619381
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-06
• Status Verified: 2021-03
• Study Start: 2021-03-19
• Primary Completion: 2021-03-19
• Study Completion: 2021-03-19
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Platelet function	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	baseline	Subjects will also complete a survey about clopidogrel adherence as well as their knowledge and attitudes about pharmacogenomic testing.
Clopidogrel resistance	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.
Participant Adherence to Plavix as Measured by Clopidogrel Metabolites in Plasma	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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States