NCT07569692尚未招募不适用
A Comparison of Initial Invasive Strategy and Initial Conservative Strategy for the Treatment of Vulnerable Atherosclerotic Coronary Plaques Identified by Coronary CT Angiography
Seung-Jung Park1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2026年7月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- The event rate of Composite of death from cardiac causes, target-vessel myocardial infarction, unplanned urgent revascularization, or hospitalization for unstable or progressive angina at 3 years after randomization.
研究概览
简要总结
The PREVENT-2 trial is to determine whether an initial invasive strategy-consisting of early coronary angiography (CAG) with intent for preventive percutaneous coronary intervention (PCI) in addition to optimal medical therapy (OMT)-reduces the incidence of the primary composite outcome of cardiac death, target-vessel myocardial infarction (MI), unplanned urgent revascularization, or hospitalization for unstable or progressive angina at 3 years, compared with an initial conservative strategy of optimal medical therapy (OMT) alone, in patients with high-risk vulnerable plaque identified by coronary computed tomography angiography (CCTA).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years
- •Patients with suspected coronary artery disease (CAD) (e.g., chest pain syndrome or equivalent symptoms) who are evaluated with coronary computed tomography angiography (CCTA)
- •Coronary computed tomography angiography (CCTA) showing:
- •Plaque with at least moderate stenosis in one or more major epicardial coronary arteries; and
- •At least two high-risk plaque (HRP) feature at the site of stenotic lesions, defined as any of the following:
- •Low-attenuation plaque (LAP) (<70 Hounsfield units)
- •Positive remodeling (PR) (remodeling index >1.2)
- •Napkin-ring sign (NRS)
- •Spotty calcification (SC) (<3 mm in length)
- •Willing and able to provide written informed consent
排除标准
- •Acute coronary syndrome (ACS) requiring urgent or emergent invasive evaluation
- •Hemodynamically unstable conditions
- •Significant left main coronary artery disease (≥50% diameter stenosis)
- •Coronary anatomy unsuitable for either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
- •Left ventricular ejection fraction (LVEF) <35%
- •→ Left ventricular ejection fraction <35%
- •New York Heart Association (NYHA) class III or IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months
- •Prior coronary artery bypass grafting (CABG)
- •Severe renal dysfunction (estimated glomerular filtration rate <30 mL/min/1.73 m²) or end-stage renal disease on dialysis
- •Contraindication to undergoing coronary computed tomography angiography (CTA) (e.g., allergy to radiographic contrast that cannot be adequately premedicated, any prior anaphylaxis to radiographic contrast, or inability to cooperate with scan acquisition)
- •Contraindications to or planned discontinuation of dual antiplatelet therapy within 1 year
- •Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
- •Planned cardiac or major noncardiac surgery within the study period
- •Women who are breastfeeding, pregnant, or planning to become pregnant during the course of the study
- •Inability to comply with the study protocol
- •Active participation in another interventional clinical trial involving an unapproved investigational drug or device
研究组 & 干预措施
Initial Invasive Strategy
Experimental
干预措施: Initial Invasive Strategy (Procedure)
Initial Conservative Strategy
Active Comparator
干预措施: Initial Conservative Strategy (Drug)
结局指标
主要结局
The event rate of Composite of death from cardiac causes, target-vessel myocardial infarction, unplanned urgent revascularization, or hospitalization for unstable or progressive angina at 3 years after randomization.
时间窗: 3 years
次要结局
- The event rate of Death (all-cause, cardiac, or non-cardiac causes)(3 years)
- The event rate of Myocardial Infarction (any, periprocedural or spontaneous; target-vessel or non-target-vessel)(3 years)
- The event rate of Revascularization (any, target-vessel, non-target-vessel)(3 years)
- The event rate of Unplanned hospitalization for unstable or progressive angina(3 years)
- The event rate of Hospitalization (any, cardiac or noncardiac causes)(3 years)
- The event rate of Individual components of the primary composite outcome(3 years)
- The event rate of Stent thrombosis (definite or probable)(3 years)
- The event rate of stroke (any, ischemic, or hemorrhagic)(3 years)
- The event rate of Bleeding events (Bleeding Academic Research Consortium (BARC) criteria)(3 years)
- The event rate of Procedural complications requiring active intervention related to Percutaneous coronary intervention(3 years)
- Patient-oriented composite outcome (POCO) (a composite of all-cause death, all myocardial infarction, or any repeat revascularization)(3 years)
- Change in Angina-related quality of life (assessed by the Seattle Angina Questionnaire [SAQ])(Baseline, 6 months, 1 year, 2 years, and 3 years)
- Economic evaluation of healthcare resource use, costs, and cost-effectiveness(From baseline to 3 years; assessed at 1 month, 6 months, 1 year, 2 years, and 3 years)
研究者
Seung-Jung Park
Professor in Department of Cardiology, Asan Medical Center
Asan Medical Center
研究点 (1)
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