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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Initial Conservative Strategy; Procedure: Initial Invasive Strategy

• Study Type: Interventional
• Enrollment (Estimated): 2500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Duk-woo Park Professor in Department of Cardiology, Asan Medical Center, MD, PhD; Phone Number: 82-2-3010-4812; Email: dwpark@amc.seoul.kr

Study Locations

• South Korea
  • Seoul, South Korea
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Initial Invasive Strategy	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.
Active Comparator: Initial Conservative Strategy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The event rate of Individual components of the primary composite outcome	death from cardiac causes, target-vessel myocardial infarction, unplanned urgent revascularization, or hospitalization for unstable or progressive angina at 3 years after randomization.	3 years
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 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	Healthcare resource utilization (including hospitalizations, procedures, and outpatient visits) will be collected and used to estimate total healthcare costs. Cost-effectiveness will be assessed using the incremental cost-effectiveness ratio (ICER), expressed as cost per quality-adjusted life year (QALY) gained. These components will be analyzed within a unified economic evaluation framework.	From baseline to 3 years; assessed at 1 month, 6 months, 1 year, 2 years, and 3 years

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea
• Investigators: Principal Investigator: Duk-woo Park, MD, PhD, Asan Medical Center; Principal Investigator: Jung-min Ahn, MD, PhD, Asan Medical Center; Principal Investigator: Do-yoon Kang, MD, PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): July 30, 2031
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: May 2, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: coronary computed tomography angiography; vulnerable plaque; preventive percutaneous coronary intervention
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: AMCCV 2026-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No