Clopidogrel After Surgery for Coronary Artery Disease (CASCADE Trial): Does Clopidogrel Prevent Saphenous Vein Graft Disease After Coronary Bypass?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Vein Graft Intimal Area
研究概览
简要总结
The purpose of this study is to determine whether the combination of clopidogrel with aspirin prevents the development of blockages (atherosclerosis) in vein grafts one year after coronary artery bypass surgery (CABG) compared to aspirin alone.
详细描述
Saphenous vein graft disease remains a major limitation of coronary artery bypass graft surgery (CABG). The process of saphenous vein intimal hyperplasia is mediated by platelet aggregation and begins just days after surgical revascularization. Subsequently, areas of intimal hyperplasia in turn develop graft atherosclerotic disease and its sequelae. Clopidogrel improves outcomes in patients with atherosclerotic disease, and is effective at reducing intimal hyperplasia in animal models of thrombosis. Therefore, the goal of this study will be to evaluate the efficacy of clopidogrel and aspirin therapy versus aspirin alone in the prevention of saphenous vein graft intimal hyperplasia following one year after CABG.
Patients undergoing multi-vessel CABG and in whom at least two saphenous vein grafts will be used are eligible for the study. Patients will be randomized to receive daily clopidogrel 75 mg or placebo, in addition to daily aspirin 162 mg, for the duration of one year starting as soon as postoperative bleeding has been ruled out on the day of surgery. At the end of one year, all patients will undergo coronary angiography and intravascular ultrasound assessment of one saphenous vein graft as selected by randomization. The study will be powered to test the hypothesis that clopidogrel and aspirin will reduce vein graft intimal hyperplasia by 20% compared to aspirin alone at one year following bypass surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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 < 25%
- •Serum creatinine > 130 µmol/L
- •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
75mg Clopidogrel
75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery.
干预措施: Clopidogrel 75 mg daily (Drug)
Placebo
Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery.
干预措施: water pill daily (Drug)
结局指标
主要结局
Vein Graft Intimal Area
时间窗: One year following surgery
IVUS imaging 12 months post-CABG, and the average intimal area in the proximal 40 mm of one vein graft per patient will be assessed
次要结局
- Incidence of Major Adverse Coronary Events Within One Year Following Surgery(1 year)
- Vein Graft Angiographic Patency(One year following surgery)
- Incidence of Major Bleeding Events Within One Year Following Surgery(1 year)