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

NCT07569692 | Not Yet Recruiting DMC

• 1 other identifier: AMCCV 2026-03
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Coronary Artery Disease

Keywords

vulnerable plaque; coronary computed tomography angiography; preventive percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• The event rate of Individual components of the primary composite outcome

  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

Study Arms (2)

Initial Invasive Strategy

EXPERIMENTAL

Procedure: Initial Invasive Strategy

Initial Conservative Strategy

ACTIVE COMPARATOR

Drug: Initial Conservative Strategy

Interventions

Initial Conservative Strategy DRUG

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.

Initial Conservative Strategy

Initial Invasive Strategy PROCEDURE

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)

Initial Invasive Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 one 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seung-Jung Park: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Duk-woo Park, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Jung-min Ahn, MD, PhD

  Professor in Department of Cardiology, Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duk-woo Park Professor in Department of Cardiology, Asan Medical Center, MD, PhD

CONTACT

82-2-3010-4812; dwpark@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in Department of Cardiology, Asan Medical Center

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): July 30, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

KR (1)