Early Intensive Lipid-Lowering With Inclisiran for Plaque Stabilization in Acute Coronary Syndrome

NCT07799779 · tracked via the Priya Life Science South Korea tracker

Sponsor

Seoul National University Bundang Hospital

Phase

Phase 4

Started

2026-09

Last updated

2026-09-02

Condition(s) studied

Acute Coronary Syndromes (ACS)

Investigational drug(s) / intervention(s)

Inclisiran →Atorvastatin or RosuvastatinAll Atorvastatin trials (44) →All Rosuvastatin trials (36) →Ezetimibe →

Inclisiran: 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).

Atorvastatin or Rosuvastatin: 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: 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.

Study summary

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.

Eligibility

Sex

ALL

Min age

19 Years

Max age

85 Years

Healthy volunteers

Inclusion Criteria: 1. Age 19 to 85 years. 2. 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. 3. 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. 4. 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. 5. Provision of voluntary written informed consent after receiving sufficient information regarding the study objectives, procedures, and follow-up plan. Exclusion Criteria: 1. Severe hepatic dysfunction, defined as AST or ALT \>3 times the upper limit of normal. 2. CK \>5 times the upper limit of normal or suspected clinically significant myopathy. 3. Severe renal impairment, defined as eGFR \<30 mL/min/1.73 m². 4. Severe hypersensitivity to or contraindication to statins, ezetimibe, or inclisiran. 5. Pregnancy, breastfeeding, or plans to become pregnant during the study period. 6. Inability to undergo 12-month follow-up coronary angiography and OCT. 7. Life expectancy \<1 year or, in the investigator's judgment, inappropriate participation in the study because of concerns regarding adherence or safety.

Primary outcome measure(s)

Change in Minimal Fibrous Cap Thickness — 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.

Trial sites (1)

Facility	City	Region	Status
Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

On this site

📄 Leqvio (inclisiran) drug profile → 📄 Zetia (ezetimibe) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07799779 on ClinicalTrials.gov ↗ ← All trials in South Korea