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ACTIVE NOT 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 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

DRUG

Rosuvastatin

Rosuvastatin 20mg once daily

DRUG

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