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RECRUITING
NCT06767345
PHASE4

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

Sponsor: Korea University Anam Hospital

View on ClinicalTrials.gov

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.

Official title: Comparing the Moderate Intensity STatin With Ezetimibe COmbination TheraPy With High Intensity Statin Monotherapy on Coronary PLAQUE Stabilization

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

408

Start Date

2025-05-12

Completion Date

2028-06-25

Last Updated

2025-09-15

Healthy Volunteers

No

Interventions

DRUG

statins, ezetimibe

Rosuvastatin 20mg once daily

DRUG

Combination therapy

Rosuvastatin 10mg + Ezetimibe 10mg

Locations (1)

Korea University Anam Hospital

Seoul, Seoul, South Korea