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NCT07569692

PREventive Invasive Strategy for Obstructive Coronary Artery Disease With Vulnerable Plaque Evaluated by CoroNary Computed Tomography Angiography-2

Sponsor: Seung-Jung Park

View on ClinicalTrials.gov

Summary

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).

Official title: A Comparison of Initial Invasive Strategy and Initial Conservative Strategy for the Treatment of Vulnerable Atherosclerotic Coronary Plaques Identified by Coronary CT Angiography

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2500

Start Date

2026-07-30

Completion Date

2031-12-31

Last Updated

2026-05-11

Healthy Volunteers

Conditions

Coronary Artery Disease

Interventions

PROCEDURE

Initial Invasive Strategy

Invasive coronary angiography (CAG) within 30 days after randomization, with the intent to perform preventive percutaneous coronary intervention (PCI) in addition to optimal medical therapy (OMT). For further detailed assessment of vulnerable plaque lesions detected by coronary computed tomography angiography, the use of intracoronary imaging modalities (near-infrared spectroscopy, optical coherence tomography, or intravascular ultrasound) will be strongly recommended.

DRUG

Initial Conservative Strategy

Optimal medical therapy (OMT) alone, with invasive coronary angiography (CAG) reserved only for failure of optimal medical therapy, defined as recurrent or worsening symptoms despite maximally tolerated medical therapy, or the occurrence of an acute coronary event.

Inclusion Criteria: 1. Patients aged ≥18 years 2. Patients with suspected coronary artery disease (CAD) (e.g., chest pain syndrome or equivalent symptoms) who are evaluated with coronary computed tomography angiography (CCTA) 3. 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) 4. Willing and able to provide written informed consent Exclusion Criteria: 1. Acute coronary syndrome (ACS) requiring urgent or emergent invasive evaluation 2. Hemodynamically unstable conditions 3. Significant left main coronary artery disease (≥50% diameter stenosis) 4. Coronary anatomy unsuitable for either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) 5. Left ventricular ejection fraction (LVEF) \<35% → Left ventricular ejection fraction \<35% 6. 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 7. Prior coronary artery bypass grafting (CABG) 8. Severe renal dysfunction (estimated glomerular filtration rate \<30 mL/min/1.73 m²) or end-stage renal disease on dialysis 9. 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) 10. Contraindications to or planned discontinuation of dual antiplatelet therapy within 1 year 11. Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity 12. Planned cardiac or major noncardiac surgery within the study period 13. Women who are breastfeeding, pregnant, or planning to become pregnant during the course of the study 14. Inability to comply with the study protocol 15. Active participation in another interventional clinical trial involving an unapproved investigational drug or device

Locations (1)

Asan Medical Center

Seoul, South Korea