Coronary Artery DiseasePREVENT-2NCT07569692
PREventive Invasive Strategy for Obstructive Coronary Artery Disease With Vulnerable Plaque Evaluated by CoroNary Computed Tomography Angiography-2
A study testing Initial Invasive Strategy and Initial Conservative Strategy in people with Coronary Artery Disease, run by Duk-Woo Park, MD at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Initial Invasive Strategy and Initial Conservative Strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Dec 2026to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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%
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- 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
- Active participation in another interventional clinical trial involving an unapproved investigational drug or device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Duk-woo Park Professor in Department of Cardiology, Asan Medical Center, MD, PhD contact
About this study
Official title: 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).
- Conditions
- Coronary Artery Disease
- Being tested
- Initial Invasive Strategy, Initial Conservative Strategy
- Keywords
- vulnerable plaque, coronary computed tomography angiography, preventive percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial Invasive StrategyProcedure or surgery
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.
Initial Conservative StrategyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Initial Invasive Strategy | Experimental | Not described Receives: Procedure: Initial Invasive Strategy |
| Initial Conservative Strategy | Active comparator | Not described Receives: Drug: Initial Conservative Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (13)
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.
Measured: 3 years
The event rate of Death (all-cause, cardiac, or non-cardiac causes)
Measured: 3 years
The event rate of Myocardial Infarction (any, periprocedural or spontaneous; target-vessel or non-target-vessel)
Measured: 3 years
The event rate of Revascularization (any, target-vessel, non-target-vessel)
Measured: 3 years
The event rate of Unplanned hospitalization for unstable or progressive angina
Measured: 3 years
The event rate of Hospitalization (any, cardiac or noncardiac causes)
Measured: 3 years
The event rate of Stent thrombosis (definite or probable)
Measured: 3 years
The event rate of stroke (any, ischemic, or hemorrhagic)
Measured: 3 years
The event rate of Bleeding events (Bleeding Academic Research Consortium (BARC) criteria)
Measured: 3 years
The event rate of Procedural complications requiring active intervention related to Percutaneous coronary intervention
Measured: 3 years
Patient-oriented composite outcome (POCO) (a composite of all-cause death, all myocardial infarction, or any repeat revascularization)
Measured: 3 years
Change in Angina-related quality of life (assessed by the Seattle Angina Questionnaire [SAQ])
Measured: 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.
Measured: From baseline to 3 years; assessed at 1 month, 6 months, 1 year, 2 years, and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start30 Dec 2026 (estimated)
- Primary completion30 Jul 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duk-Woo Park, MD
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Duk-Woo Park, MD, Asan Medical Center
- Investigators
- Seung-jung Park, MD, PhD, Study chair, Asan Medical CenterJung-min Ahn, MD, PhD, Principal investigator, Asan Medical CenterDo-yoon Kang, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569692
- Sponsor's protocol ID
- AMCCV 2026-03
- Acronym
- PREVENT-2
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Initial Invasive Strategy and Initial Conservative Strategy for the Treatment of Vulnerable Atherosclerotic Coronary Plaques Identified by Coronary CT Angiography
- ClinicalTrials.gov ID
- NCT07569692
- Acronym / sponsor ID
- PREVENT-2 / AMCCV 2026-03
- Conditions
- Coronary Artery Disease
- Keywords
- vulnerable plaque, coronary computed tomography angiography, preventive percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Duk-Woo Park, MDUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 30 Jul 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial Invasive Strategy | Experimental | Procedure: Initial Invasive Strategy |
| Initial Conservative Strategy | Active comparator | Drug: Initial Conservative Strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (16 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial Invasive StrategyInvasive 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. | Procedure or surgery | Initial Invasive Strategy |
| Initial Conservative StrategyOptimal 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. | Drug | Initial Conservative Strategy |
Primary outcome
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
13 secondary outcomes
The event rate of Individual components of the primary composite outcome
Time frame: 3 years
The event rate of Death (all-cause, cardiac, or non-cardiac causes)
Time frame: 3 years
The event rate of Myocardial Infarction (any, periprocedural or spontaneous; target-vessel or non-target-vessel)
Time frame: 3 years
The event rate of Revascularization (any, target-vessel, non-target-vessel)
Time frame: 3 years
The event rate of Unplanned hospitalization for unstable or progressive angina
Time frame: 3 years
The event rate of Hospitalization (any, cardiac or noncardiac causes)
Time frame: 3 years
The event rate of Stent thrombosis (definite or probable)
Time frame: 3 years
The event rate of stroke (any, ischemic, or hemorrhagic)
Time frame: 3 years
The event rate of Bleeding events (Bleeding Academic Research Consortium (BARC) criteria)
Time frame: 3 years
The event rate of Procedural complications requiring active intervention related to Percutaneous coronary intervention
Time frame: 3 years
Patient-oriented composite outcome (POCO) (a composite of all-cause death, all myocardial infarction, or any repeat revascularization)
Time frame: 3 years
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
Economic evaluation of healthcare resource use, costs, and cost-effectiveness
Time frame: From baseline to 3 years; assessed at 1 month, 6 months, 1 year, 2 years, and 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Duk-woo Park Professor in Department of Cardiology, Asan Medical Center, MD, PhD contact
Seung-jung Park, MD, PhD study chair
Asan Medical Center
Jung-min Ahn, MD, PhD principal investigator
Asan Medical Center
Do-yoon Kang, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial Invasive Strategy and Initial Conservative Strategy in people with Coronary Artery Disease, run by Duk-Woo Park, MD at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duk-woo Park Professor in Department of Cardiology, Asan Medical Center, MD, PhD (82-2-3010-4812, dwpark@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.