PREventive Invasive Strategy for Obstructive Coronary Artery Disease With Vulnerable Plaque Evaluated by CoroNary Computed Tomography Angiography-2 (PREVENT-2)
6. mai 2026 oppdatert 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).
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
2500
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Duk-woo Park Professor in Department of Cardiology, Asan Medical Center, MD, PhD
- Telefonnummer: 82-2-3010-4812
- E-post: dwpark@amc.seoul.kr
Studiesteder
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Seoul, Sør -Korea
- Asan Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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.
Tidsramme: 3 years
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3 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The event rate of Individual components of the primary composite outcome
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 3 years
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3 years
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The event rate of Revascularization (any, target-vessel, non-target-vessel)
Tidsramme: 3 years
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3 years
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The event rate of Unplanned hospitalization for unstable or progressive angina
Tidsramme: 3 years
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3 years
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The event rate of Hospitalization (any, cardiac or noncardiac causes)
Tidsramme: 3 years
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3 years
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The event rate of Stent thrombosis (definite or probable)
Tidsramme: 3 years
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3 years
|
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The event rate of stroke (any, ischemic, or hemorrhagic)
Tidsramme: 3 years
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3 years
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The event rate of Bleeding events (Bleeding Academic Research Consortium (BARC) criteria)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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])
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Duk-woo Park, MD, PhD, Asan Medical Center
- Hovedetterforsker: Jung-min Ahn, MD, PhD, Asan Medical Center
- Hovedetterforsker: Do-yoon Kang, MD, PhD, Asan Medical Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
30. juli 2026
Primær fullføring (Antatt)
30. juli 2031
Studiet fullført (Antatt)
31. desember 2031
Datoer for studieregistrering
Først innsendt
24. april 2026
Først innsendt som oppfylte QC-kriteriene
2. mai 2026
Først lagt ut (Faktiske)
6. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AMCCV 2026-03
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