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Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization
Sponsor: Korea University Anam Hospital
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 change in percent atheroma volume (PAV) from baseline to week 52, assessed by grayscale IVUS. Secondary outcomes include changes in lipid core burden, inflammatory markers, and clinical events like myocardial infarction and ischemic stroke. Seven hospitals participated in the study. A total of 408 participants were enrolled at six sites; no participants were enrolled at Inje University Ilsan Paik Hospital. Follow-up is ongoing.
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
2026-10-06
Healthy Volunteers
No
Interventions
Rosuvastatin
Rosuvastatin 20mg once daily
Rosuvastatin/ezetimibe
Rosuvastatin 10mg + Ezetimibe 10mg
Locations (7)
Korea University Anam Hospital
Seoul, Seoul, South Korea
Inje University Ilsan Paik Hospital
Goyang, South Korea
Kyung Hee University Hospital
Seoul, South Korea
Hanyang University Hospital
Seoul, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea