NCT07569692Not yet recruiting
PREventive Invasive Strategy for Obstructive Coronary Artery Disease With Vulnerable Plaque Evaluated by CoroNary Computed Tomography Angiography-2
A Comparison of Initial Invasive Strategy and Initial Conservative Strategy for the Treatment of Vulnerable Atherosclerotic Coronary Plaques Identified by Coronary CT Angiography
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 2500 (estimated)
- First submitted
- 24 Apr 2026
- Start date
- 30 Dec 2026
- Primary completion date
- 30 Jul 2031
- Lead sponsor
- Duk-Woo Park, MD
- Diseases
- Coronary artery disease
- NCT number
- NCT07569692
What you commit to
- Study type: Interventional
- Planned participants: 2500
- From 30 Dec 2026 to the primary completion date, 30 Jul 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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
- Active participation in another interventional clinical trial involving an unapproved investigational drug or device
Other illness
- Acute coronary syndrome (ACS) requiring urgent or emergent invasive evaluation
- Hemodynamically unstable conditions
- Significant left main coronary artery disease (≥50% diameter stenosis)
- Severe renal dysfunction (estimated glomerular filtration rate \<30 mL/min/1.73 m²) or end-stage renal disease on dialysis
- Planned cardiac or major noncardiac surgery within the study period
Lab values
- Left ventricular ejection fraction (LVEF) \<35%
- → Left ventricular ejection fraction \<35%
Other
- Coronary anatomy unsuitable for either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
- Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
- Women who are breastfeeding, pregnant, or planning to become pregnant during the course of the study
- Inability to comply with the study protocol
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.