Impact of a High-fat Meal on Assessment of Clopidogrel-induced Platelet Inhibition in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Platelet inhibition
研究概览
简要总结
The purpose of this study is to determine whether a high-fat meal affects the ability of platelet function tests to measure platelet inhibition by clopidogrel.
详细描述
The purpose of this study is to determine the influence of a high-fat meal on assessment of clopidogrel-induced platelet inhibition in healthy people using platelet function assays. Twelve healthy adult subjects will be recruited to take part in this research study. After consent is obtained, subjects will be asked to present to the clinical research center after a 12 hour fast. A baseline blood sample will be drawn at 8 am, and subjects will then be administered a 600 mg dose of clopidogrel. At 12 noon, another blood sample will be drawn to evaluate the extent of maximum platelet inhibition in the fasting state. Subjects will then be provided a standardized high-fat meal with an additional blood sample at 2 pm to evaluate the impact of the high-fat on platelet function assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •19 years of age or older
- •healthy subjects
- •deny taking medications that affect platelet function for at least 7 days prior to test
排除标准
- •history of cardiovascular disease
- •any risk factors for cardiovascular disease
- •surgery in last 3 months
- •history of anemia/thrombocytopenia
- •pregnancy
结局指标
主要结局
Platelet inhibition
时间窗: 3 time points over 6 hours
platelet inhibition before versus after a high-fat meal (measured by light transmission aggregometry, whole blood aggregometry, flow cytometry, and VerifyNow assay)
次要结局
未报告次要终点