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

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.

NCT Number	NCT06767345
Lead Sponsor	Korea University Anam Hospital Collaborators: Yuhan Corporation, Hanmi Pharmaceutical co., ltd.
Conditions	Coronary Artery Disease, Atherosclerosis of Coronary Artery, Plaque, Atherosclerotic
Enrollment	408 participants
Start Date	2025-05-12
Primary Completion	2028-01-25 (estimated)
Study Completion	2028-06-25 (estimated)
Updated on ClinicalTrials.gov	2025-09-15