A Phase 4 interventional study of Inclisiran and Atorvastatin or Rosuvastatin in Acute Coronary Syndromes (ACS), sponsored by Seoul National University Bundang Hospital. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Seoul National University Bundang Hospital · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Drug: Inclisiran · Drug: Atorvastatin or Rosuvastatin · Drug: Ezetimibe
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.
Drug: Atorvastatin or Rosuvastatin · Drug: Ezetimibe
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.
Change in Minimal Fibrous Cap Thickness
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.
Time frame: Baseline to 12 months
Change in OCT-Derived Lipid Plaque Characteristics
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.
Time frame: Baseline to 12 months
Change in Lipid Parameters and LDL-C Target Attainment
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).
Time frame: Baseline to 12 months
Changes in IVUS-Derived Plaque Burden in the IVUS Substudy
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.
Time frame: Baseline to 12 months
Exploratory Clinical Events
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.
Time frame: Up to 12 months
Plan to share: No
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Seoul National University Bundang Hospital