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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSeung-Jung Park

About this trial

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).

Eligibility criteria

Qualifiers

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)

Low-attenuation plaque (LAP) (<70 Hounsfield units)

Positive remodeling (PR) (remodeling index >1.2)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Initial Invasive Strategy
  • Initial Conservative Strategy

Treatment groups

2,500 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Seung-Jung Park

Lead sponsor

Asan Medical Center

Sponsor institution

CardioVascular Research Foundation, Korea

Collaborator