an Investigator-initiated, Multicenter, Open-label, 2-by-2 Factorial, and Randomized Trial to Evaluate the Role of Aspirin and High-intensity Statin Therapy, Respectively, in Individuals With Severe Coronary Calcification (Coronary Calcium Score ≥300) to Prevent Atherosclerotic Cardiovascular Disease (ASCVD) Events With Severe Coronary Calcification (CAC ≥300)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 32
- 主要终点
- Event rate of a composite of atherosclerotic cardiovascular disease event
研究概览
简要总结
The primary objective of the ASA-3C trial is to evaluate the role of aspirin and high-intensity statin therapy, respectively, in individuals with severe coronary calcification (coronary calcium score ≥300) to prevent atherosclerotic cardiovascular disease (ASCVD) events with severe coronary calcification (CAC ≥300).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must be aged between 40 and 75 years.
- •Patients who have coronary artery calcium score ≥300 Agatston Unit on coronary calcium computed tomography.
- •Patients who have 1 or more CVD risk factors in below;
- •dyslipidemia or,
- •diabetes or,
- •hypertension or,
- •family history of CVD or,
- •Patients agree to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
排除标准
- •Individuals who have symptomatic coronary artery disease or heart failure.
- •Patients who have documented clinical Atherosclerotic Cardiovascular Disease: previous myocardial infarction, acute coronary syndrome, stable angina, coronary revascularization and other arterial revascularization procedures, stroke and Transient ischaemic attack (TIA), >50% carotid stenosis or previous carotid endarterectomy or stenting, aortic aneurysm and peripheral artery disease.
- •Patients who have evidence of myocardial ischemia on non-invasive stress test including stress single photon emission CT myocardial perfusion imaging (SPECT MPI), cardiovascular magnetic resonance (CMR) imaging, stress echocardiography, or treadmill test, or on invasive stress test including Fractional flow reserve (FFR) < 0.80 on invasive coronary angiography (diameter stenosis>50% without objective evidence of ischemia could be enrolled).
- •Patients at high risk of bleeding: gastrointestinal hemorrhage or peptic ulcer within the previous 6 months; active hepatic disease such as cirrhosis or active hepatitis; use of warfarin, or other anticoagulant therapy; or has a history of aspirin allergy.
- •Patients with atrial fibrillation and flutter.
- •Patients with severe left ventricular dysfunction (ejection fraction ≤30%) or severe valvular heart disease who experience dyspnea on exertion (The NYHA (New York Heart Association) Functional Classification III-IV).
- •History of allergy or severe adverse reaction to aspirin or statin or ezetimibe.
- •History of myositis or myopathy with active disease in the 180 days prior to study entry.
- •Patients with active liver disease or persistent unexplained serum transaminase elevation.
- •Patients who have significantly abnormal findings which identified violation for safety by investigator on physical examination, blood test and electrocardiogram.
- •History of alcohol or drug abuse.
- •Concurrent medical condition with a life expectancy of less than 1 years.
- •Pregnant and/or lactating women.
- •Patient was unable to provide written informed consent or participate in log-term follow up.
研究组 & 干预措施
No aspirin and High-intensity statin
Patients will take no aspirin and high-intensity statin therapy. Statin intensity is defined according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia
干预措施: High-intensity statin (Drug)
Aspirin and High-intensity statin
Patients will take aspirin 100 mg/day and high-intensity statin therapy. Statin intensity is defined according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia
干预措施: Aspirin (Drug)
Aspirin and guideline-directed statin
Patients will take aspirin 100 mg/day and guideline-directed statin therapy.
干预措施: Aspirin (Drug)
Aspirin and guideline-directed statin
Patients will take aspirin 100 mg/day and guideline-directed statin therapy.
干预措施: Guideline-directed statin therapy (Drug)
Aspirin and High-intensity statin
Patients will take aspirin 100 mg/day and high-intensity statin therapy. Statin intensity is defined according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia
干预措施: High-intensity statin (Drug)
No aspirin and guideline-directed statin
Patients will take no aspirin and guideline-directed statin therapy.
干预措施: Guideline-directed statin therapy (Drug)
结局指标
主要结局
Event rate of a composite of atherosclerotic cardiovascular disease event
时间窗: 3 years
cardiovascular death; myocardial infarction ; hospitalization for Acute coronary syndrome; stroke; Transient ischaemic attack; peripheral arterial ischemia ;revascularization of coronary, carotid, or peripheral artery ;or death from an undetermined cause
次要结局
- Event rate of Death from any causes(3 years)
- Event rate of Hospitalization for heart failure(3 years)
- Event rate of Each individual component of primary composite outcome(3 years)
- Event rate of the first occurrence of any major bleeding(3 years)
- Event rate of the Safety secondary endpoint(3 years)
研究者
Jung-min Ahn
Professor, Cardiology, Aortic Disease Center, Cardiovascular Disease Prevention & Rehabilitation Center, Asan Medical Center Heart Institute, Valvular Heart Disease Center, Ischemic Heart Disease Center
Asan Medical Center