Aspirin in Subclinical Coronary Artery Disease: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Monthly Recruitment Rate
研究概览
简要总结
In patients with subclinical coronary artery disease, the ASCAD-P study aims to assess the feasibility of a larger phase 3 pragmatic randomized controlled trial comparing prescription versus no prescription of low-dose aspirin in routine clinical practice.
详细描述
Cardiovascular disease remains the leading cause of mortality worldwide. Recent large randomized trials have demonstrated limited net clinical benefit of aspirin in unselected primary prevention populations, leading to guideline recommendations against its systematic routine use for cardiovascular protection.
Patients with subclinical coronary artery disease represent a high-risk subgroup. These individuals have documented coronary artery disease but have not experienced overt cardiovascular events or undergone revascularization. Observational data suggest that this population carries a substantially increased risk of myocardial infarction compared with individuals without coronary atherosclerosis. However, the benefit-risk balance of aspirin in this intermediate-risk group remains uncertain
Primary Objective:
To evaluate the recruitment rate of a pilot randomized trial comparing low-dose aspirin prescription versus no prescription.
Secondary Objectives
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
- •Documented coronary atherosclerosis, as defined by one of the following criteria:
- •Coronary artery calcium (CAC) score > 0;
- •Cardiac CT angiography (CCTA) / CoroScan: lesions <70% in the right coronary (RCA), left anterior descending (LAD), and circumflex (Cx) arteries or their branches, and <50% in the left main coronary artery;
- •Coronary angiography: lesions <70% in the right coronary (RCA), left anterior descending (LAD), and circumflex (Cx) arteries or their branches, and <50% in the left main coronary artery; if performed, physiological coronary assessments (FFR, dPR, iFR, etc.) and intracoronary imaging (IVUS or OCT) must be negative for significant disease.
- •Willing and able to provide informed consent and comply with study procedures
排除标准
- •History of myocardial infarction (MI), coronary revascularization, stroke, transient ischemic attack (TIA), or peripheral arterial revascularization procedure;
- •Current prescription or clear indication for aspirin, low-molecular-weight heparin (LMWH), direct oral anticoagulants, or any other antithrombotic medication;
- •Clear contraindication to aspirin;
- •History of significant bleeding within the past year;
- •Severe illness with limited life expectancy (i.e., <5 years);
- •Any condition that, in the investigator's judgment, would make participation unsafe for the patient.
研究组 & 干预措施
Low-dose Aspirin Prescription
Aspirin 81 mg orally once daily prescription
干预措施: Prescription of Aspirin (Drug)
No Prescription
No prescription of aspirin 81 mg orally once daily
干预措施: No prescription (Drug)
结局指标
主要结局
Monthly Recruitment Rate
时间窗: 12 months following study enrollment initiation
Average monthly patient recruitment rate: 0 ≤ Mean rate (patients/month) \< 2 = study not feasible; 2 ≤ Mean rate (patients/month) \< 4 = study feasible with protocol modifications; ≥ 4 Mean rate (patients/month) = study feasible without major protocol modifications.
次要结局
- Proportion of Eligible Patients Randomized(12 months following study enrollment initiation)
- Intervention Persistence(From randomization to end of follow-up (12 months))
- Proportion of Patients Lost to Follow-up(End of follow-up (12 months))
- Barriers to Recruitment, Adherence, and Patient Retention(From recruitment to the end of follow-up (12 months))
- Intervention Adherence(From randomization to the end of follow-up (12 months))
研究者
Guillaume Marquis-Gravel
Principal Investigator
Montreal Heart Institute