NCT00938522Unknown4 期
PREtreatment of Cilostazol Loading in Elective Percutaneous Coronary Intervention to Decrease Adverse Events
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization)
研究概览
简要总结
The purpose of this study is to investigate the effect of cilostazol loading before planned PCI on major adverse cardiac and cerebrovascular events in patients with coronary artery disease.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective PCI
- •Presence of coronary lesions amenable to stent
排除标准
- •Cardiogenic shock
- •Urgent PCI
- •Hypersensitivity to aspirin, clopidogrel, or cilostazol
- •LVEF < 30% or congestive heart failure
- •Bleeding diathesis
- •leukocyte count < 3,000/mm3 and/or platelet count < 100,000/mm3
- •aspartate aminotransferase or alanine aminotransferase > 3 times upper normal; serum creatinine > 2.0 mg/dl
- •noncardiac disease with a life expectancy < 1 year
- •inability to follow the protocol
研究组 & 干预措施
Cilostazol loading
Experimental
干预措施: Cilostazol (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization)
时间窗: at 3 months after PCI
次要结局
- Late loss on quantitative coronary angiography(9 months after index PCI)
- % neointimal area [100 x (stent area-lumen area)/stent area] on IVUS(9 months after index PCI)
- Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization)(12 months after index PCI)
研究者
研究点 (1)
Loading locations...
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