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Not yet recruitingNCT07569692PREVENT-2Updated May 11, 2026

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

An interventional study of Initial Invasive Strategy and Initial Conservative Strategy in Coronary Artery Disease, sponsored by Seung-Jung Park. Not yet recruiting at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by Seung-Jung Park · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
2,500
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • vulnerable plaque
  • coronary computed tomography angiography
  • preventive percutaneous coronary intervention
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,500 participants (estimated)

Study arms

  • Experimental
    Initial Invasive Strategy

    Procedure: Initial Invasive Strategy

  • Active comparator
    Initial Conservative Strategy

    Drug: Initial Conservative Strategy

Interventions

  • ProcedureInitial 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.

  • DrugInitial 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.

05

What researchers measure

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.

    Time frame: 3 years

Secondary outcomes

  1. 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.

    Time frame: 3 years

  2. The event rate of Death (all-cause, cardiac, or non-cardiac causes)

    Time frame: 3 years

  3. The event rate of Myocardial Infarction (any, periprocedural or spontaneous; target-vessel or non-target-vessel)

    Time frame: 3 years

  4. The event rate of Revascularization (any, target-vessel, non-target-vessel)

    Time frame: 3 years

  5. The event rate of Unplanned hospitalization for unstable or progressive angina

    Time frame: 3 years

  6. The event rate of Hospitalization (any, cardiac or noncardiac causes)

    Time frame: 3 years

  7. The event rate of Stent thrombosis (definite or probable)

    Time frame: 3 years

  8. The event rate of stroke (any, ischemic, or hemorrhagic)

    Time frame: 3 years

  9. The event rate of Bleeding events (Bleeding Academic Research Consortium (BARC) criteria)

    Time frame: 3 years

  10. The event rate of Procedural complications requiring active intervention related to Percutaneous coronary intervention

    Time frame: 3 years

  11. Patient-oriented composite outcome (POCO) (a composite of all-cause death, all myocardial infarction, or any repeat revascularization)

    Time frame: 3 years

  12. Change in Angina-related quality of life (assessed by the Seattle Angina Questionnaire [SAQ])

    Time frame: Baseline, 6 months, 1 year, 2 years, and 3 years

  13. 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.

    Time frame: From baseline to 3 years; assessed at 1 month, 6 months, 1 year, 2 years, and 3 years

06

Study locations

1 site
  • Asan Medical Center
    Seoul, South Korea
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07569692
Lead sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
Responsible party
Seung-Jung Park (Professor in Department of Cardiology, Asan Medical Center, Asan Medical Center) — Sponsor-investigator
First posted
May 6, 2026
Start date
Jul 30, 2026 (estimated)
Primary completion
Jul 30, 2031 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
May 11, 2026

Study contacts

Duk-woo Park Professor in Department of Cardiology, Asan Medical Center, MD, PhD
Contact
dwpark@amc.seoul.kr
82-2-3010-4812
Duk-woo Park, MD, PhD
principal investigator · Asan Medical Center
Jung-min Ahn, MD, PhD
principal investigator · Asan Medical Center
Do-yoon Kang, MD, PhD
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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