NCT02797548已完成4 期
Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery
Jung-min Ahn35 个研究点 分布在 3 个国家目标入组 1,010 人开始时间: 2017年3月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,010
- 试验地点
- 35
- 主要终点
- The event rate of composite event of all-cause death, stent thrombosis, myocardial infarction, and stroke
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of perioperative antiplatelet therapy in patients with drug-eluting stent undergoing non-cardiac surgery.
详细描述
Subjects who can not be randomized due to any reason will be enrolled at observational group.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned non-cardiac surgery at least after 12 months of implantation of drug eluting stent
- •Low or intermediate risk level surgery
- •Written informed consent
排除标准
- •Acute coronary syndrome within 1 month
- •Heart failure NYHA III to IV
- •Contraindication to Aspirin
- •On anticoagulant therapy
- •Emergent surgery
- •Cardiac surgery
- •High bleeding risk surgeries, e.g., Intra-cranial surgery, Intra-spinal surgery, Retinal surgery
- •Pregnancy or breast-feeding
- •Life expectancy less than 1year
研究组 & 干预措施
Aspirin only
Experimental
干预措施: Aspirin only (Drug)
No antiplatelet therapy
Active Comparator
干预措施: No antiplatelet therapy (Drug)
结局指标
主要结局
The event rate of composite event of all-cause death, stent thrombosis, myocardial infarction, and stroke
时间窗: 30 days
A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed.
次要结局
- The event rate of all cause death(30 days)
- The event rate of stroke(30 days)
- The event rate of stent thrombosis(30 days)
- The event rate of cardiac death(30 days)
- The event rate of myocardial infarction(30 days)
- The event rate of repeat revascularization(30 days)
- The event rate of life threatening bleeding(30 days)
- The event rate of major bleeding(30 days)
- Quality of life score assessed by the EQ-5D-5L(30 days)
- Quality of life score assessed by Health-related Quality of Life Instrument with 8 Items (HINT-8)(30 days)
- Cost-effective analysis(30 days)
研究者
Jung-min Ahn
Assistant Professor
Asan Medical Center
研究点 (35)
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