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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04619381
• Other study ID #: 171699
• Status: Withdrawn
• Start date: March 19, 2021
• Est. completion date: March 19, 2021

Study information

• Verified date: March 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 19, 2021
• Est. primary completion date: March 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Platelet function	Platelet function will be measured using the VerifyNow-P2Y12 point-of-care assay.	baseline
Primary	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