Effect of Different Dosing Regimens of Clopidogrel Given Before Elective Percutaneous Coronary Intervention on Platelet Function
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The primary objective of this study was to evaluate the effect of four different dosing regimens of clopidogrel on platelet aggregation at the time of diagnostic coronary angiography, and 2 hours after stenting.
研究概览
简要总结
Adequate platelet inhibition before percutaneous coronary intervention (PCI) reduces peri-procedural and long-term ischemic complications. Documented reduced response to clopidogrel has been associated with subsequent major adverse cardiovascular events. Strategies to optimize platelet inhibition pre-PCI are under investigation.
This study sought to evaluate the effect on platelet aggregation of four different dosing regimens of clopidogrel given before elective PCI.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient with an indication for elective coronary angiography with or without PCI
排除标准
- •major hemorrhagic diathesis or active bleeding
- •acute myocardial infarction (MI) within 14 days of enrolment
- •unstable angina with ST-segment changes >1 mm in at least two contiguous electrocardiographic leads at rest or a troponin I level >0.06 microg/L within 14 days of enrolment
- •stroke within the past 3 months
- •platelet count <100 x 10 9/L
- •prothrombin time > 1.5 times control
- •hematocrit <25% or hemoglobin level <100 g/L
- •alcohol or drug abuse
- •enrolment in other investigational drug trials within the previous month
- •use of thienopyridines, glycoprotein (GP) IIb/IIIa inhibitors, warfarin or acenocoumarol within the previous week
- •allergic reaction or any contraindication to clopidogrel or aspirin administration
研究组 & 干预措施
1
Clopidogrel 300 mg the day before PCI
干预措施: Clopidogrel (Drug)
2
Clopidogrel 600 mg the day before PCI
干预措施: Clopidogrel (Drug)
3
300 mg followed by 75 mg daily started one week prior to angiography
干预措施: Clopidogrel (Drug)
4
300 mg followed by 150 mg daily started one week prior to angiography
干预措施: Clopidogrel (Drug)
结局指标
主要结局
The primary objective of this study was to evaluate the effect of four different dosing regimens of clopidogrel on platelet aggregation at the time of diagnostic coronary angiography, and 2 hours after stenting.
时间窗: 7 days
次要结局
- A secondary objective in patients stented was the 30-day incidence of the composite of death, myocardial infarction (MI) or urgent target vessel revascularization.(30 days)