Optimal PERioperative Antiplatelet Therapy Investigation ON Abdominal Surgery After Coronary Stent Implantation
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- a composite of death or myocardial infarction
研究概览
简要总结
The purpose of this study is to evaluate the impact of perioperative aspirin continuation on clinical outcomes in patients with a history of coronary stent implantation who are scheduled for abdominal surgery.
详细描述
PCI with coronary stent implantation is performed for a huge number of patients with coronary artery disease. Approximately 20% of these patients undergo non-cardiac surgery within three years after PCI. However, there is a scarcity of clinical evidence regarding the efficacy of perioperative aspirin continuation on cardiovascular events.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a history of coronary stenting and scheduled for abdominal surgery
- •Patients on a single antiplatelet agent
排除标准
- •Patients on dual antiplatelet therapy (DAPT)
- •Patients on anticoagulation therapy
- •Patients with a history of stent thrombosis
- •Patients with CHADS2 score >= 5
- •Patients at extremely high risk of bleeding and unable to continue preoperative aspirin
- •Patients incapable of consent, including those under 20 years of age
- •Other patients for whom either discontinuation or continuation of antiplatelet agents is deemed inappropriate by the attending physician
研究组 & 干预措施
Aspirin Continuation
perioperative aspirin continuation
干预措施: Aspirin (Drug)
Interruption of Antiplatelet Therapy
Interruption of aspirin 5-7 days before surgery
干预措施: Aspirin interruption (Drug)
结局指标
主要结局
a composite of death or myocardial infarction
时间窗: 30 days
the primary endpoint is defined as a composite of all-cause death or myocardial infarction (4th UDMI definition)
次要结局
- Death/Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)(30 days)
- Major bleeding (TIMI major/minor bleeding)(30 days)
- Death/Myocardial Infarction (4th UDMI Definition)/Stroke(30 days)
- Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)(30 days)
- Death/Myocardial Infarction (ARC-2 Definition)/Stroke(30 days)
- Death(30 days)
- Cardiovascular Death(30 days)
- Myocardial Infarction (4th UDMI Definition)(30 days)
- Myocardial Infarction (ARC-2 Definition)(30 days)
- Myocardial Infarction (SCAI Definition)(30 days)
- Myocardial Infarction (modified POISE-2 Definition)(30 days)
- Myocardial Injury (MINS)(30 days)
- Stent Thrombosis (ARC Definition)(30 days)
- Stroke(30 days)
- Cerebral Infarction(30 days)
- Cerebral Hemorrhage(30 days)
- Coronary Revascularization(30 days)
- Major Bleeding (BARC classification)(30 days)
- Major Bleeding (modified POISE-2 classification)(30 days)
- Major Bleeding (GUSTO classification)(30 days)
- Fatal Bleeding(30 days)
- Bleeding Volume During Non-Cardiac Surgery(30 days)
- Transfusion(30 days)
- Reoperation(30 days)
研究者
Hiroki Shiomi
Hiroki Shiomi MD, PhD
Kyoto University