NCT03049085Unknown4 期
Effect of Preoperative Aspirin in Patients Undergoing Off-pump Coronary Artery Bypass Grafting: A Double-blind, Placebo-controlled, Randomized Trial
Medinet Heart Centre1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Myocardial Injury
研究概览
简要总结
Effect of Preoperative Aspirin in patients undergoing Off-pump Coronary Artery Bypass Grafting. A double-blind, placebo-controlled, randomized trial.
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
- •Eligible patients undergoing off-pump coronary artery bypass grafting (OPCAB)
- •Patients in whom antiplatelet therapy was stopped 5-7 days prior to OPCAB
排除标准
- •Patients undergoing on-pump coronary artery bypass grafting
- •Patients in whom antiplatelet therapy was not stopped 5-7 days prior to OPCAB
- •Intraoperative conversion to on-pump coronary artery bypass grafting
- •Patients with inherited blood-clotting disorders
- •Patients undergoing other cardiac operations
研究组 & 干预措施
Aspirin group
Active Comparator
a 75 mg uncoated aspirin is administered 2 hours prior to OPCAB
干预措施: Aspirin (Drug)
Placebo group
Placebo Comparator
75 mg Vit. C is administered 2 hours prior OPCAB
干预措施: vitamin C (Drug)
结局指标
主要结局
Myocardial Injury
时间窗: 72 hours following OPCAB
Myocardial injury detected by CK-MB (U/l)
Inflammation
时间窗: 72 hours following OPCAB
Inflammation detected by CRP (mg/l)
Kidney Injury
时间窗: 72 hours following OPCAB
Kidney injury detected by creatinine (mg/dl)
All-cause mortality or MACE up to 30 days after surgery
时间窗: 30 days after surgery
次要结局
- Bleeding complication(< 30 days following OPCAB)
- Postoperative drainage (ml)(12 hours and 24 hours following OPCAB)
- Blood transfusions (units)(< 30 days following OPCAB)
研究者
研究点 (1)
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