Randomized Controlled Comparison: STOPping Versus Continuing Antiplatelet Therapy During Noncardiac Surgery and Procedures After Next Generation Drug-eluting Stent Implantation (STOP-ASP Trial)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- A composite of cardiac death
研究概览
简要总结
Most previous trials support the absolute increase in bleeding risk with perioperative administration of antiplatelet. Furthermore, recent studies demonstrated that perioperative major bleeding may be related to increase cardiovascular risk. The investigators will compare the efficacy and safety of continuing versus stopping antiplatelet therapy during perioperative period in patients underwent PCI(Percutaneous Coronary Intervention) with next generation DES(Drug Eluting Stent).
详细描述
Most current guidelines recommend to focus on continuing antiplatelet therapy (mostly with aspirin) during noncardiac surgery if possible. Although previous study showed efficacy of continuous antiplatelet therapy in reducing perioperative ischemic cardiovascular events, its effectiveness is still not clear between perioperative bleeding and ischemic risk. Most previous trials support the absolute increase in bleeding risk with perioperative administration of antiplatelet. Furthermore, recent studies demonstrated that perioperative major bleeding may be related to increase cardiovascular risk. The investigators will compare the efficacy and safety of continuing versus stopping antiplatelet therapy during perioperative period in patients underwent PCI(Percutaneous Coronary Intervention) with next generation DES(Drug Eluting Stent).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19-85 years
- •Planning of elective noncardiac surgery or invasive procedure
- •At least 1 year interval between the surgery or procedure and last PCI with next generation DES
- •Currently on antiplatelet therapy
排除标准
- •PCI with BMS(bare metal stent), 1st generation DES or bioresorbable vascular scaffold
- •Total length of inserted DES in the 3 vessels >60 mm
- •History of stent thrombosis
- •History of coronary artery bypass grafting surgery
- •Planned surgery or procedure with high bleeding risk including followings: intracranial neurosurgery, spinal canal surgery, and eye posterior chamber surgery, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), ampullary resection, endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy plus large-balloon papillary dilation, endoscopic ultrasonography-guided fine-needle aspiration (EUS-FNA) of cystic lesions
- •Left ventricular ejection fraction <40%
- •Myocardial infarction within 6 months
- •Any overt thromboembolism requiring medical surveillance and/or treatment
- •Any clinically overt sign of hemorrhage within 3 months
- •Anticoagulant therapy for any reason
- •Need of continuation or discontinuation of antiplatelet therapy during surgery or procedure at the discretion of cardiologist or operator
- •Any contraindication, adverse drug reaction or hypersensitivity to aspirin
- •Pregnant women or women with potential childbearing
- •Inability to understand or read the informed content
研究组 & 干预措施
Continuing aspirin
Patients in the group may continue the administration of aspirin during perioperative period.
干预措施: Continuing aspirin (Drug)
Stopping aspirin
Patients in the group may stop medication of antiplatelet drugs during perioperative period.
干预措施: Stopping aspirin (Drug)
结局指标
主要结局
A composite of cardiac death
时间窗: 1 day after discharging from the hospital
A composite of major perioperative adverse events
cerebrovascular accident
时间窗: 1 day after discharging from the hospital
A composite of major perioperative adverse events
nonfatal myocardial infarction (MI)
时间窗: 1 day after discharging from the hospital
A composite of major perioperative adverse events
definite or probable stent thrombosis
时间窗: 1 day after discharging from the hospital
A composite of major perioperative adverse events
any revascularization and BARC(Bleeding Academic Research Consortium) ≥3 bleeding during index hospitalization for surgery or procedure
时间窗: 1 day after discharging from the hospital
A composite of major perioperative adverse events
次要结局
未报告次要终点