Randomized, Factorial Study to Explore Interaction Between Aspirin and Clopidogrel in Stable Patients With Previous Myocardial Infarction or Coronary Artery Stent
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Blood concentrations of the active metabolite of clopidogrel
研究概览
简要总结
This study will explore the effect of different doses of aspirin on the effects of double-dose or standard dose clopidogrel.
详细描述
Study Hypothesis: Patients receiving double-dose compared with standard-dose clopidogrel will have increased blood concentrations of the active metabolite of clopidogrel and greater inhibition of ADP-induced platelet aggregation when also treated with acetylsalicylic acid (ASA) 325 mg/d as compared to ASA 81 mg/d.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •> 1 month post myocardial infarction (MI), unstable angina or stent patients with stable condition
- •Receiving regular ASA (81mg/d) and clopidogrel (75mg/d) for at least 1 week
- •Written informed consent
排除标准
- •Age < 18 years old
- •Liver disease with transaminases and/or bilirubin > 1.5x upper limits of normal (ULN) (within 3 months of randomization)
- •Renal impairment with creatinine clearance < 30 ml/min (within 3 months of randomization)
- •Platelet count < 100x109/L and/or Hb< 100g/L (within 3 months of randomization)
- •Use of oral anticoagulants or nonsteroidal antiinflammatory drug (NSAID) within the last 10 days or planned use during the study
- •Use of antiplatelet agent other than aspirin and clopidogrel within the last 10 days
- •High risk of bleeding (e.g. recent gastrointestinal bleeding, bleeding diathesis)
- •Uncontrolled hypertension (> 180/110mmHg)
- •Current smoker with ≥ 5 cigarettes/day
- •Previously entered in this study or just finished other study within 2 weeks before recruitment
- •Medical, geographic, or social factors making study participation impractical, or inability to provide written informed consent
研究组 & 干预措施
Standard dose clopidogrel
300 mg Loading x 1 day, 75 mg/d x 13 days
干预措施: Clopidogrel (Drug)
Double dose clopidogrel
600 mg Loading x 1 day, 150 mg/d x 6 days, 75 mg/d x 7 days
干预措施: Clopidogrel (Drug)
Standard dose aspirin
Aspirin 81mg/d x 14 days
干预措施: Aspirin (Drug)
High dose aspirin
Aspirin 325 mg/d x 14 days
干预措施: Aspirin (Drug)
结局指标
主要结局
Blood concentrations of the active metabolite of clopidogrel
时间窗: 14 days
次要结局
- Inhibition of adenosine diphosphate (ADP) induced platelet aggregation(14 days)
研究者
John Eikelboom
MD.
Population Health Research Institute