Randomized Controlled Trial 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
- 302
- 试验地点
- 1
- 主要终点
- Blood Concentration of the Active Metabolite of Clopidogrel
研究概览
简要总结
Clopidogrel and aspirin are commonly used in combination to prevent heart attacks and to prevent blockage of stents. Both clopidogrel and aspirin work by preventing platelets (sticky cells that circulate in the blood) from forming blood clots in the arteries supplying oxygen to the heart and in stents. The investigators hypothesize that aspirin 325mg compared with aspirin 81 mg will increase blood levels of the active metabolite of clopidogrel in patients with a history of coronary artery disease who receive a 600mg loading dose of clopidogrel.
详细描述
Eligible patients will be randomized to receive clopidogrel 600mg + aspirin 325mg (Group A) or clopidogrel 600mg + aspirin 81mg (Group B). Patients will be fasted for at least 8 hours prior to study drug administration. Blood samples will be collected at 1 hour after study drug administration for measurement of clopidogrel active metabolite levels and genotyping.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Stable patients >1 month post ACS (including ST elevated myocardial infarction, non-ST elevated myocardial infarction or unstable angina) or stent
- •Receiving regular ASA (81mg/d) and clopidogrel (75mg/d) for at least 1 week
- •Written informed consent
排除标准
- •Age < 18 years
- •Liver disease with ALT or bilirubin >2x upper limits of normal (ULN)*
- •Renal impairment with creatinine clearance <30 ml/min*
- •Deemed to be at high risk of bleeding (e.g., recent bleeding, platelet count<100x109/L or hemoglobin <100g/L)*
- •Anticoagulant or NSAID therapy within the last 5 days
- •Antiplatelet agent other than aspirin and clopidogrel within the last 10 days
- •Uncontrolled hypertension (>=180/110mmHg)
- •within 3 months of planned randomization
研究组 & 干预措施
Higher dose aspirin group
Clopidogrel 600 mg plus aspirin 325mg
干预措施: Clopidogrel (Drug)
Higher dose aspirin group
Clopidogrel 600 mg plus aspirin 325mg
干预措施: Aspirin (Drug)
Low dose aspirin group
Clopidogrel 600mg plus aspirin 81mg
干预措施: Clopidogrel (Drug)
Low dose aspirin group
Clopidogrel 600mg plus aspirin 81mg
干预措施: Aspirin (Drug)
结局指标
主要结局
Blood Concentration of the Active Metabolite of Clopidogrel
时间窗: 1 hour after loading dose of study medications
Clopidogrel active metabolite concentration will be measured by liquid chromatography tandem mass spectrometry (LC/MS) methods.
次要结局
未报告次要终点
研究者
John Eikelboom
Dr
Population Health Research Institute