NCT00776477Unknown3 期
The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease
China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2007年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Vein graft patency examined by CT scan
研究概览
简要总结
Clopidogrel is a antiplatelet agent and is effective at reducing intimal hyperplasia in animal models of thrombosis.Several large clinical trials have demonstrated that clopidogrel with aspirin can reduce ischemic events and mortality in patients with atherosclerotic disease,therefore the combination of two antiplatelets might be useful to prevent patients received coronary artery bypass graft surgery from Saphenous vein graft disease. the aim of this study is to estimate the safety and efficacy of clopidogrel and aspirin therapy versus aspirin alone in patients after CABG.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing primary multi-vessel CABG with at least two saphenous vein grafts, with or without the use of cardiopulmonary bypass.
排除标准
- •Emergency surgery
- •Valve surgery
- •Redo CABG
- •Left ventricle ejection fraction < 30%
- •Preoperative use of clopidogrel (with the exception of the current admission)
- •Preoperative use of warfarin
- •Allergy to aspirin or clopidogrel
- •History of cerebrovascular accident
- •History of severe liver disease
- •Morbid obesity
- •Current malignancy
研究组 & 干预措施
1
Experimental
干预措施: clopidogrel and aspirin (Drug)
2
Active Comparator
干预措施: aspirin (Drug)
结局指标
主要结局
Vein graft patency examined by CT scan
时间窗: three months after surgery
次要结局
- Incidence of major adverse coronary events Incidence of major bleeding events(two years following surgery)
研究者
研究点 (1)
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