Coronary Artery Disease
Conditions
Keywords
African American, Coronary Artery Disease, Anti Platelet
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.
Interventions
BEHAVIORALCORONARY ARTERY DISEASE AND CLOPIDOGREL: PATIENT SURVEY
Survey is a non-standardized assessment of demographics, medication compliance and reasons for non- compliance.
Sponsors
Vanderbilt University Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed