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

NCT04619381 | Withdrawn

• 1 other identifier: 171699
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 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. 2.A better understanding of challenges to taking clopidogrel as prescribed by a doctor and opinions about a genetic test related to this medicine.

Conditions

Coronary Artery Disease

Keywords

African American; Coronary Artery Disease; Anti Platelet

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

African Americans with Coronary Artery Disease

African Americans with Coronary Artery Disease and currently taking clopidogrel

Behavioral: CORONARY ARTERY DISEASE AND CLOPIDOGREL: PATIENT SURVEY

Interventions

CORONARY ARTERY DISEASE AND CLOPIDOGREL: PATIENT SURVEY BEHAVIORAL

Survey is a non-standardized assessment of demographics, medication compliance and reasons for non- compliance.

African Americans with Coronary Artery Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• years of age or older
• Sex: Male and Female
• Race: Self-identified as African American
• History of percutaneous coronary intervention in the past 12 months
• Currently taking aspirin and clopidogrel for at least one month and up to one year
• English speaking

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Aaron Aday, MD

  VUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine Division of Cardiovascular Medicine

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 6, 2020
• Study Start: March 19, 2021
• Primary Completion: March 19, 2021
• Study Completion: March 19, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)