PREventive Invasive Strategy for Obstructive Coronary Artery Disease With Vulnerable Plaque Evaluated by CoroNary Computed Tomography Angiography-2 (PREVENT-2)
6 maj 2026 uppdaterad av: Seung-Jung Park
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).
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
2500
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Duk-woo Park Professor in Department of Cardiology, Asan Medical Center, MD, PhD
- Telefonnummer: 82-2-3010-4812
- E-post: dwpark@amc.seoul.kr
Studieorter
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Seoul, Sydkorea
- Asan Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Active participation in another interventional clinical trial involving an unapproved investigational drug or device
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Initial Invasive Strategy
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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. |
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Aktiv komparator: Initial Conservative Strategy
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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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.
Tidsram: 3 years
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3 years
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The event rate of Individual components of the primary composite outcome
Tidsram: 3 years
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death from cardiac causes, target-vessel myocardial infarction, unplanned urgent revascularization, or hospitalization for unstable or progressive angina at 3 years after randomization.
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3 years
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The event rate of Death (all-cause, cardiac, or non-cardiac causes)
Tidsram: 3 years
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3 years
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The event rate of Myocardial Infarction (any, periprocedural or spontaneous; target-vessel or non-target-vessel)
Tidsram: 3 years
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3 years
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The event rate of Revascularization (any, target-vessel, non-target-vessel)
Tidsram: 3 years
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3 years
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The event rate of Unplanned hospitalization for unstable or progressive angina
Tidsram: 3 years
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3 years
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The event rate of Hospitalization (any, cardiac or noncardiac causes)
Tidsram: 3 years
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3 years
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The event rate of Stent thrombosis (definite or probable)
Tidsram: 3 years
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3 years
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The event rate of stroke (any, ischemic, or hemorrhagic)
Tidsram: 3 years
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3 years
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The event rate of Bleeding events (Bleeding Academic Research Consortium (BARC) criteria)
Tidsram: 3 years
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3 years
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The event rate of Procedural complications requiring active intervention related to Percutaneous coronary intervention
Tidsram: 3 years
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3 years
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Patient-oriented composite outcome (POCO) (a composite of all-cause death, all myocardial infarction, or any repeat revascularization)
Tidsram: 3 years
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3 years
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Change in Angina-related quality of life (assessed by the Seattle Angina Questionnaire [SAQ])
Tidsram: Baseline, 6 months, 1 year, 2 years, and 3 years
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Baseline, 6 months, 1 year, 2 years, and 3 years
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Economic evaluation of healthcare resource use, costs, and cost-effectiveness
Tidsram: From baseline to 3 years; assessed at 1 month, 6 months, 1 year, 2 years, and 3 years
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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.
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From baseline to 3 years; assessed at 1 month, 6 months, 1 year, 2 years, and 3 years
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Duk-woo Park, MD, PhD, Asan Medical Center
- Huvudutredare: Jung-min Ahn, MD, PhD, Asan Medical Center
- Huvudutredare: Do-yoon Kang, MD, PhD, Asan Medical Center
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
30 juli 2026
Primärt slutförande (Beräknad)
30 juli 2031
Avslutad studie (Beräknad)
31 december 2031
Studieregistreringsdatum
Först inskickad
24 april 2026
Först inskickad som uppfyllde QC-kriterierna
2 maj 2026
Första postat (Faktisk)
6 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AMCCV 2026-03
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