Early Intensive Lipid-Lowering With Inclisiran for Plaque Stabilization in Acute Coronary Syndrome (SEsiR-ACS)
2026년 8월 28일 업데이트: Chang-Hwan Yoon, Seoul National University Bundang Hospital
Statin, Ezetimibe, and Inclisiran for Plaque Regression in Acute Coronary Syndrome: A Randomized Controlled Trial (SEsiR-ACS Trial)
This multicenter, randomized, open-label clinical trial will evaluate whether an early intensive lipid-lowering strategy can improve coronary plaque stabilization in patients hospitalized with acute coronary syndrome. A total of 294 participants will be randomly assigned in a 1:1 ratio to either an early intensive treatment strategy with a high-intensity statin, ezetimibe, and inclisiran, or a guideline-based stepwise lipid-lowering strategy.
Coronary plaque characteristics will be assessed using optical coherence tomography (OCT) at baseline and at 12 months. The primary outcome is the change in minimal fibrous cap thickness from baseline to 12 months. Additional assessments will include other OCT-based plaque characteristics, lipid levels, safety outcomes, and, in a subset of participants, intravascular ultrasound measurements of plaque burden.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
294
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Chang-Hwan Yoon, MD, PhD
- 전화번호: +82-031-787-7019
- 이메일: changhwanyoon@gmail.com
연구 장소
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, 대한민국, 13620
- Seoul National University Bundang Hospital
-
연락하다:
- Chang-Hwan Yoon
- 전화번호: +82-031-787-7019
- 이메일: changhwanyoon@gmail.com
-
-
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:
- Age 19 to 85 years.
- Hospitalization for acute coronary syndrome (UA, NSTEMI, or STEMI) with planned coronary angiography and PCI, or PCI already performed during the index hospitalization with adequate baseline OCT images obtained during the procedure that meets the study imaging analysis criteria.
- Presence of a target vessel/segment considered by the investigator to be suitable for OCT assessment at baseline and at the 12-month follow-up.
LDL-C level at screening meeting one of the following criteria according to background lipid-lowering therapy:
i) ≥40 mg/dL in patients receiving stable combination therapy with a statin and ezetimibe, defined as no dose change for at least 4 weeks before screening; ii) ≥55 mg/dL in patients receiving high-intensity statin therapy; iii) ≥70 mg/dL in patients receiving low- or moderate-intensity statin therapy; or iv) ≥100 mg/dL in patients not receiving stable statin therapy.
- Provision of voluntary written informed consent after receiving sufficient information regarding the study objectives, procedures, and follow-up plan.
Exclusion Criteria:
- Severe hepatic dysfunction, defined as AST or ALT >3 times the upper limit of normal.
- CK >5 times the upper limit of normal or suspected clinically significant myopathy.
- Severe renal impairment, defined as eGFR <30 mL/min/1.73 m².
- Severe hypersensitivity to or contraindication to statins, ezetimibe, or inclisiran.
- Pregnancy, breastfeeding, or plans to become pregnant during the study period.
- Inability to undergo 12-month follow-up coronary angiography and OCT.
- Life expectancy <1 year or, in the investigator's judgment, inappropriate participation in the study because of concerns regarding adherence or safety.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Early Intensive Lipid-Lowering Strategy
Participants will receive an early intensive lipid-lowering strategy consisting of a high-intensity statin, ezetimibe 10 mg once daily, and inclisiran 284 mg by subcutaneous injection initiated during the index hospitalization or as early as feasible.
Inclisiran will be repeated at 3 months and 9 months.
|
Inclisiran sodium 284 mg/1.5 mL will be administered by subcutaneous injection in the early intensive lipid-lowering group.
Inclisiran will be initiated during the index hospitalization or as early as feasible thereafter, within 2 weeks, followed by additional doses at 3 months (±2 weeks) and 9 months (±2 weeks).
High-intensity statin therapy will consist of atorvastatin 40-80 mg orally once daily or rosuvastatin 20 mg orally once daily, or the maximally tolerated dose.
High-intensity statin therapy will be initiated or continued during the index hospitalization in both treatment groups.
Ezetimibe 10 mg will be administered orally once daily.
In the early intensive lipid-lowering group, ezetimibe will be initiated during the index hospitalization.
In the guideline-based stepwise intensification group, ezetimibe will be added according to follow-up LDL-C levels if the treatment target is not achieved with high-intensity statin therapy.
|
|
활성 비교기: Guideline-Based Stepwise Intensification Strategy
Participants will receive a guideline-based stepwise lipid-lowering strategy.
High-intensity statin therapy will be initiated or continued during the index hospitalization.
Ezetimibe will be added according to follow-up LDL-C levels, and a PCSK9 inhibitor may be considered if the LDL-C target remains unmet.
|
High-intensity statin therapy will consist of atorvastatin 40-80 mg orally once daily or rosuvastatin 20 mg orally once daily, or the maximally tolerated dose.
High-intensity statin therapy will be initiated or continued during the index hospitalization in both treatment groups.
Ezetimibe 10 mg will be administered orally once daily.
In the early intensive lipid-lowering group, ezetimibe will be initiated during the index hospitalization.
In the guideline-based stepwise intensification group, ezetimibe will be added according to follow-up LDL-C levels if the treatment target is not achieved with high-intensity statin therapy.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Minimal Fibrous Cap Thickness
기간: Baseline to 12 months
|
Change from baseline to 12 months in minimal fibrous cap thickness (FCT), measured by optical coherence tomography (OCT) in one prespecified representative matched non-stented coronary plaque or segment per participant.
|
Baseline to 12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in OCT-Derived Lipid Plaque Characteristics
기간: Baseline to 12 months
|
Changes from baseline to 12 months in maximum lipid arc, mean lipid arc, lipid length, lipid index, and the prevalence of thin-cap fibroatheroma (TCFA), assessed by optical coherence tomography (OCT) in matched non-stented coronary plaque segments.
|
Baseline to 12 months
|
|
Change in Lipid Parameters and LDL-C Target Attainment
기간: Baseline to 12 months
|
Absolute and percentage changes in LDL-C from baseline during follow-up, achievement of the prespecified LDL-C target, defined as LDL-C <40 mg/dL and a reduction of at least 50% from baseline, and changes in non-HDL-C, hsCRP, and, when available, ApoB and Lp(a).
|
Baseline to 12 months
|
|
Changes in IVUS-Derived Plaque Burden in the IVUS Substudy
기간: Baseline to 12 months
|
Change from baseline to 12 months in percent atheroma volume (PAV), assessed by intravascular ultrasound (IVUS) in matched non-stented coronary segments.
Additional IVUS assessments include changes in total atheroma volume (TAV) and plaque burden.
|
Baseline to 12 months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Exploratory Clinical Events
기간: Up to 12 months
|
Exploratory clinical events will include cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, unplanned revascularization, and hospitalization.
Event numbers and cumulative incidence rates will be assessed during follow-up.
|
Up to 12 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 9월 1일
기본 완료 (추정된)
2029년 9월 1일
연구 완료 (추정된)
2029년 9월 1일
연구 등록 날짜
최초 제출
2026년 8월 28일
QC 기준을 충족하는 최초 제출
2026년 8월 28일
처음 게시됨 (실제)
2026년 9월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 28일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- B-2607-1057-003
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .