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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07569692
PREventive Invasive Strategy for Obstructive Coronary Artery Disease With Vulnerable Plaque Evaluated by CoroNary Computed Tomography Angiography-2 (PREVENT-2)
A Comparison of Initial Invasive Strategy and Initial Conservative Strategy for the Treatment of Vulnerable Atherosclerotic Coronary Plaques Identified by Coronary CT Angiography
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Duk-woo Park Professor in Department of Cardiology, Asan Medical Center, MD, PhD
- Número de teléfono: 82-2-3010-4812
- Correo electrónico: dwpark@amc.seoul.kr
Ubicaciones de estudio
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Seoul, Corea del Sur
- Asan Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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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.
Periodo de tiempo: 3 years
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3 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The event rate of Individual components of the primary composite outcome
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 3 years
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3 years
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The event rate of Revascularization (any, target-vessel, non-target-vessel)
Periodo de tiempo: 3 years
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3 years
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The event rate of Unplanned hospitalization for unstable or progressive angina
Periodo de tiempo: 3 years
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3 years
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The event rate of Hospitalization (any, cardiac or noncardiac causes)
Periodo de tiempo: 3 years
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3 years
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The event rate of Stent thrombosis (definite or probable)
Periodo de tiempo: 3 years
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3 years
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The event rate of stroke (any, ischemic, or hemorrhagic)
Periodo de tiempo: 3 years
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3 years
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The event rate of Bleeding events (Bleeding Academic Research Consortium (BARC) criteria)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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])
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Duk-woo Park, MD, PhD, Asan Medical Center
- Investigador principal: Jung-min Ahn, MD, PhD, Asan Medical Center
- Investigador principal: Do-yoon Kang, MD, PhD, Asan Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AMCCV 2026-03
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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