NCT06767345

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 408 (estimated)
• Sponsor: Korea University Anam Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Coronary Artery Disease
• Atherosclerosis of Coronary Artery
• Plaque, Atherosclerotic

Interventions

Type	Name	Description
DRUG	statins, ezetimibe	Rosuvastatin 20mg once daily
DRUG	Combination therapy	Rosuvastatin 10mg + Ezetimibe 10mg

Timeline

• Start date: 2025-05-12
• Primary completion: 2028-01-25
• Completion: 2028-06-25
• First posted: 2025-01-09
• Last updated: 2025-09-15

Locations

1 site across 1 country: South Korea