Efficacy and Safety of Clopidogrel for Primary Prevention in Patients With Subclinical Coronary Atherosclerosis Identified on Imaging
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 11,086
- 试验地点
- 54
- 主要终点
- Major adverse cardiovascular and cerebrovascular events (MACCE)
研究概览
简要总结
The investigators will evaluate the efficacy and safety of clopidogrel for primary prevention in patients diagnosed with coronary atherosclerosis on imaging that did not require revascularization therapy.
The trial will test the hypothesis that clopidogrel is beneficial in preventing major adverse cardiovascular and cerebrovascular events (MACCE) in patients with subclinical coronary atherosclerosis identified on imaging.
详细描述
Coronary artery disease (CAD) is the most prevalent and lethal disease worldwide. Even though various studies have been performed regarding the prevention or treatment of CAD and its related cardiovascular events, the prevalence of CAD and the incidence of cardiovascular events are increasing.
Antiplatelet agents are among the most widely used drugs for preventing cardiovascular events. The efficacy of antiplatelet agents has been extensively proven in secondary prevention for cardiovascular events in CAD patients, and their use has been recommended in current guidelines. However, there is still controversy surrounding the prescription of antiplatelet agents for the primary prevention of cardiovascular events in CAD patients due to their unknown clear efficacy and risk of bleeding complications.
Recent studies reported the limited efficacy of aspirin in old patients, diabetes patients, or patients with cardiovascular events risks. However, the efficacy or safety of antiplatelet therapy in patients with subclinical coronary atherosclerosis has not been thoroughly investigated. These patients are at higher risk of cardiac death or myocardial infarction compared to patients without coronary atherosclerosis.
In this regard, the investigators will evaluate the efficacy and safety of clopidogrel for primary prevention in patients diagnosed with coronary atherosclerosis on imaging that did not require revascularization therapy.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged ≥40 years
- •Patients with subclinical coronary atherosclerosis identified from coronary CT angiography or coronary angiography within 2 years without clinical events after an imaging study
- •Without significant coronary artery stenosis (Diameter stenosis >50%), which needs revascularization
- •Agreement to give written informed consent
排除标准
- •A history of a diagnosed cardiovascular or cerebrovascular disease (Type1 myocardial infarction, heart failure, peripheral artery disease, stroke, transient ischemic attack, carotid artery stenosis>50%, carotid artery intervention)
- •A history of coronary artery intervention or coronary artery bypass graft surgery, which needs chronic maintenance of antiplatelet therapy
- •Absolute contraindication or allergy to clopidogrel
- •Patients receiving anticoagulants for other comorbidities
- •A history of Bleeding diathesis, known coagulopathy, or major bleeding, BARC class ≥3, resulting in the stop of antiplatelet agents
- •Planned surgery or intervention which needs to stop antiplatelet agents ≥1 month
- •Presence of non-cardiac comorbidity with life expectancy ≤ 5 years at randomization
- •Females with pregnancy or breast-feeding
- •Patients who are thought to be inappropriate for the trial based on physicians' decision
研究组 & 干预措施
Clopidogrel treatment group
Patients assigned to the clopidogrel treatment group will maintain clopidogrel 75mg once a day for at least 5 years.
干预措施: Clopidogrel treatment group (Drug)
No antiplatelet or anticoagulant group
Patients assigned to the no antiplatelet or anticoagulant group will not prescribe antithrombotics for at least 5 years. However, when there is a medical need for antithrombotic therapy during the follow-up, the prescription of antithrombotics is permitted with reporting to the research board.
干预措施: No antiplatelet or anticoagulant group (Other)
结局指标
主要结局
Major adverse cardiovascular and cerebrovascular events (MACCE)
时间窗: at 2 years after the last enrollment
A composite of all-cause death, non-fatal myocardial infarction, any coronary revascularization, ischemic stroke, or transient ischemic attack
次要结局
- Major adverse cardiovascular and cerebrovascular events (MACCE)(at 5 years after the last enrollment)
- Net adverse clinical event(at 2 years and 5 years after the last enrollment)
- All-cause death(at 2 years and 5 years after the last enrollment)
- Non-fatal myocardial infarction(at 2 years and 5 years after the last enrollment)
- Any coronary revascularization(at 2 years and 5 years after the last enrollment)
- Ischemic stroke or Transient ischemic attack(at 2 years and 5 years after the last enrollment)
- Any non-coronary revascularization(at 2 years and 5 years after the last enrollment)
- Major bleeding events(at 2 years and 5 years after the last enrollment)
- BARC type 2 bleeding events(at 2 years and 5 years after the last enrollment)
- BARC type 3 bleeding events(at 2 years and 5 years after the last enrollment)
- BARC type 5 bleeding events(at 2 years and 5 years after the last enrollment)
研究者
Hyo-Soo Kim
Professor
Seoul National University Hospital