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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
408
Rosuvastatin 20mg once daily
Rosuvastatin 10mg + Ezetimibe 10mg
Korea University Anam Hospital
Seoul, Seoul, South Korea
RECRUITINGpercentage change in coronary atheroma volume (PAV) by gray-scale IVUS from baseline to week 52.
Time frame: 52 weeks
Change from baseline to week 52 in total lipid core BMI measured by NIRS (LCBItotal)
Time frame: 52 weeks
Change in maximum LCBI within a 4-mm bin measured by NIRS from baseline to week 52 (maxLCBI4mm)
Time frame: 52 weeks
Change in corrected total atherosclerotic plaque volume (NTAV) measured by IVUS from baseline to week 52
Time frame: 52 weeks
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