Investigation of the Causes of Health Disparities in African Americans With Coronary Artery Disease on Clopidogrel
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Patient-level barriers to implementation of routine pharmacogenomic testing for antiplatelet therapy
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Use of nonsteroidal anti-inflammatory drugs
- •Pregnancy will be excluded in women of child-bearing potential using urine pregnancy test
结局指标
主要结局
Patient-level barriers to implementation of routine pharmacogenomic testing for antiplatelet therapy
时间窗: baseline
Subjects will also complete a survey about clopidogrel adherence as well as their knowledge and attitudes about pharmacogenomic testing.
Clopidogrel resistance
时间窗: 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
时间窗: baseline
Platelet function will be measured using the VerifyNow-P2Y12 point-of-care assay.
Participant Adherence to Plavix as Measured by Clopidogrel Metabolites in Plasma
时间窗: 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.
次要结局
未报告次要终点
研究者
Aaron Aday
Instructor in Medicine Division of Cardiovascular Medicine
Vanderbilt University Medical Center