Phase 4Active, not recruitingAge-related condition
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
- Sponsor
- Korea University Anam Hospital (Academic or other)
- Enrolment
- 408 enrolled
- Conditions
- Coronary Artery Disease; Atherosclerosis of Coronary Artery; Plaque, Atherosclerotic
- Interventions
- Rosuvastatin; Rosuvastatin/ezetimibe
- Ages
- adults, older adults
- Registry
- NCT06767345
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change in percent atheroma volume (PAV) from baseline to week 52, assessed by gray-scale IVUS
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered