PREventive Invasive Strategy for Obstructive Coronary Artery Disease With Vulnerable Plaque Evaluated by CoroNary Computed Tomography Angiography-2 (PREVENT-2)
2026년 5월 6일 업데이트: 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).
연구 개요
연구 유형
중재적
등록 (추정된)
2500
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Duk-woo Park Professor in Department of Cardiology, Asan Medical Center, MD, PhD
- 전화번호: 82-2-3010-4812
- 이메일: dwpark@amc.seoul.kr
연구 장소
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Seoul, 대한민국
- Asan Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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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.
기간: 3 years
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3 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The event rate of Individual components of the primary composite outcome
기간: 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)
기간: 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)
기간: 3 years
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3 years
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The event rate of Revascularization (any, target-vessel, non-target-vessel)
기간: 3 years
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3 years
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The event rate of Unplanned hospitalization for unstable or progressive angina
기간: 3 years
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3 years
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The event rate of Hospitalization (any, cardiac or noncardiac causes)
기간: 3 years
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3 years
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The event rate of Stent thrombosis (definite or probable)
기간: 3 years
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3 years
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The event rate of stroke (any, ischemic, or hemorrhagic)
기간: 3 years
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3 years
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The event rate of Bleeding events (Bleeding Academic Research Consortium (BARC) criteria)
기간: 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
기간: 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)
기간: 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])
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Duk-woo Park, MD, PhD, Asan Medical Center
- 수석 연구원: Jung-min Ahn, MD, PhD, Asan Medical Center
- 수석 연구원: Do-yoon Kang, MD, PhD, Asan Medical Center
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 30일
기본 완료 (추정된)
2031년 7월 30일
연구 완료 (추정된)
2031년 12월 31일
연구 등록 날짜
최초 제출
2026년 4월 24일
QC 기준을 충족하는 최초 제출
2026년 5월 2일
처음 게시됨 (실제)
2026년 5월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 6일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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