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Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization

NCT06767345 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2025-09-15

No results posted yet for this study

Summary

This study is a prospective, multicenter, randomized clinical trial aimed at comparing the effects of moderate-intensity statin plus ezetimibe combination therapy versus high-intensity statin monotherapy on coronary plaque stabilization. Using advanced imaging techniques such as near-infrared spectroscopy-intravascular ultrasound (NIRS-IVUS), the trial evaluates whether the combination therapy is non-inferior to monotherapy in stabilizing coronary plaques over 52 weeks. The primary endpoint is the percentage change in coronary atheroma volume (PAV) assessed by grayscale IVUS, with secondary outcomes including changes in lipid core burden, inflammatory markers, and clinical events like myocardial infarction and ischemic stroke. The study plans to enroll 408 patients undergoing coronary intervention across 7 domestic institutions, with rigorous follow-up protocols and adherence to international research guidelines.

Conditions

Interventions

DRUG

statins, ezetimibe

Rosuvastatin 20mg once daily

DRUG

Combination therapy

Rosuvastatin 10mg + Ezetimibe 10mg

Sponsors & Collaborators

  • Yuhan Corporation

    collaborator INDUSTRY

  • Hanmi Pharmaceutical co., ltd.

    collaborator OTHER

  • Korea University Anam Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-12
Primary Completion
2028-01-25
Completion
2028-06-25

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT06767345 on ClinicalTrials.gov