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

NCT07799779 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2026-09-02

No results posted yet for this 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.

Conditions

  • Acute Coronary Syndromes (ACS)

Interventions

DRUG

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).

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Dotter Co., Ltd.

    collaborator UNKNOWN

  • Novartis Korea Ltd.

    collaborator INDUSTRY

  • Hanmi Pharmaceutical co., ltd.

    collaborator OTHER

  • Seoul National University Bundang Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-09-30
Completion
2029-09-30

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07799779 on ClinicalTrials.gov