Statin, Ezetimibe, and Inclisiran for Plaque Regression in Acute Coronary Syndrome: A Randomized Controlled Trial (SEsiR-ACS Trial)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Change in Minimal Fibrous Cap Thickness
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and investigators are aware of treatment-group assignment. However, OCT images are analyzed by an independent imaging core laboratory blinded to treatment allocation, and major clinical events are adjudicated by an independent Clinical Event Committee blinded to treatment assignment.
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Atorvastatin or Rosuvastatin (Drug)
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.
干预措施: Inclisiran (Drug)
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.
干预措施: Ezetimibe (Drug)
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.
干预措施: Atorvastatin or Rosuvastatin (Drug)
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.
干预措施: Ezetimibe (Drug)
结局指标
主要结局
Change in Minimal Fibrous Cap Thickness
时间窗: 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.
次要结局
- Change in OCT-Derived Lipid Plaque Characteristics(Baseline to 12 months)
- Change in Lipid Parameters and LDL-C Target Attainment(Baseline to 12 months)
- Changes in IVUS-Derived Plaque Burden in the IVUS Substudy(Baseline to 12 months)
研究者
Chang-Hwan Yoon
Professor of Cardiology
Seoul National University Bundang Hospital