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

Study Overview
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Brief Summary
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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: 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 A better understanding of challenges to taking clopidogrel as prescribed by a doctor and opinions about a genetic test related to this medicine.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Behavioral: CORONARY ARTERY DISEASE AND CLOPIDOGREL: PATIENT SURVEY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 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 Exclusion Criteria: Use of nonsteroidal anti-inflammatory drugs Pregnancy will be excluded in women of child-bearing potential using urine pregnancy test

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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African American, Coronary Artery Disease, Anti Platelet