Comparison of Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Rate of coronary endarterectomy-targeted graft patency.
研究概览
简要总结
Coronary endarterectomy (CE) combined with coronary artery bypass grafting (CABG) can be the final option for achieving complete revascularization in diffuse coronary artery disease patients. Since the exposure of subendothelial tissue to the blood flow after CE, the coagulation cascade can be activated, resulting in the increased risk of graft failure. Therefore, anticoagulation with warfarin in this group of patients might be beneficial. However, evidence is limited. This study aims to compare the clinical outcomes between dual antiplatelet therapy with or without warfarin after CE+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
- Single (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
- •Adult patients with diffuse coronary artery disease undergoing CE+CABG during the study period.
- •No contraindications for both dual antiplatelet therapy and anticoagulation therapy with warfarin.
- •Must be able to swallow tablets after the surgery.
排除标准
- •Patients with high bleeding risk (HAS-BLED ≥ 3);
- •Patients undergoing concomitant aortic valve or mitral valve surgery, or undergoing cardiac surgery for the second time;
- •Emergency surgery;
- •Serum creatinine >130μmol/L, or significant liver dysfunction (elevated ALT and/or AST);
- •History of digestive or urinary tract bleeding, active gastric bleeding caused by gastric ulcer, or postoperative new-onset gastric bleeding;
- •History of hemorrhagic stroke, or platelet dysfunction;
- •Allergic or with contraindication to any of aspirin, clopidogrel or warfarin;
- •Participated in other clinical trial for drug or device within 30 days;
- •Pregnant or planning to be pregnant.
研究组 & 干预措施
DAPT
Comparison group: dual antiplatelet only
干预措施: DAPT (Drug)
DAPT
Comparison group: dual antiplatelet only
干预措施: CE+CABG (Other)
DAPT+warfarin
Intervention group: dual antiplatelet combined with warfarin
干预措施: Warfarin (Drug)
DAPT+warfarin
Intervention group: dual antiplatelet combined with warfarin
干预措施: DAPT (Drug)
DAPT+warfarin
Intervention group: dual antiplatelet combined with warfarin
干预措施: CE+CABG (Other)
结局指标
主要结局
Rate of coronary endarterectomy-targeted graft patency.
时间窗: 6 months postoperatively
Defined as less than 50% stenosis of the coronary endarterectomy target and coronary endarterectomy-targeted graft evaluated through either of coronary computed tomography angiography or coronary angiography.
次要结局
- Bleeding events(during 6-month follow-up)
- Number of patients suffering from major adverse cardiovascular and cerebrovascular events(During 6-month follow-up)