Efficacy and Safety of Aspirin in Patients with Chronic Coronary Syndromes Without Revascularization
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,890
- 试验地点
- 1
- 主要终点
- Composite cardiovascular events
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety aspirin in patients with chronic coronary syndromes without revascularization.
详细描述
Aspirin for secondary prevention in the acute phase of acute coronary syndromes has been established. Although it is still disputable about the duration, there is also a consensus for antiplatelet therapy in patients after percutaneous coronary revascularization. On the other hand, several large randomized clinical trials (RCTs) have shown that aspirin treatment for primary prevention of cardiovascular events increases bleeding events and does not provide net clinical benefit.Patient with chronic coronary syndromes (CCS) but not eligible for revascularization do not belong to any of these categories and there is no evidence on the efficacy of aspirin in this population. Therefore, we designed a multicenter, randomized, open-label study to evaluate the efficacy and safety of aspirin in patients with CCS who are not eligible for revascularization.
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
- 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 chronic coronary syndromes with ≧50% diameter stenosis in one or more major coronary vessels/major branches on coronary CT or coronary angiography but not eligible for coronary revascularization
- •Patients for whom consent can be obtained
排除标准
- •Patients with history of acute coronary syndromes (ACS)
- •Patients with history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
- •Patients with left main trunk stenosis (≥50%)
- •Patients for whom aspirin administration is mandatory
- •Patients undergoing antithrombotic therapy other than aspirin
- •Patients with atrial fibrillation
- •Patients with history of stroke within six months
- •Patients scheduled for major surgical procedures that will require aspirin discontinuation
- •Patients with contraindication of aspirin
- •Patients expected to have a prognosis of 1 year or less due to comorbidities
- •Women of child-bearing potential or women who have a positive pregnancy test at enrolment or randomization
- •Patients who are judged by attending physicians to be inappropriate to participate in this study
研究组 & 干预措施
Aspirin
Aspirin 100 mg/day
干预措施: Aspirin (Drug)
No Aspirin
No Aspirin
干预措施: No aspirin (Drug)
结局指标
主要结局
Composite cardiovascular events
时间窗: 5 years
Composite of all-cause death, myocardial infarction, ischemic stroke, coronary revascularization, peripheral revascularization, or critical limb ischemia
次要结局
- Ischemic stroke(5 years)
- Cancer incidence(5 years)
- Peripheral revascularization(5 years)
- Myocardial infarction(5 years)
- Cardiovascular death(5 years)
- Critical limb ischemia(5 years)
- Major bleeding(5 years)
- All-cause death(5 years)
- Coronary revascularization(5 years)
- Hospital admission for heart failure(5 years)
- Cancer death(5 years)
- Composite of all-cause mortality, myocardial infarction, ischemic stroke, coronary revascularization, lower extremity revascularization, critical lower extremity ischemia, major bleeding, hospital admission for heart failure, cancer death(5 years)
研究者
Takeshi Morimoto
Study Statistician
Kyoto University, Graduate School of Medicine