Actively Recruiting
Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization
Led by Korea University Anam Hospital · Updated on 2025-09-15
408
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
Sponsors
K
Korea University Anam Hospital
Lead Sponsor
Y
Yuhan Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men and women over the age of 18 years.
- Patients with coronary artery disease undergoing a coronary intervention procedure using intravascular imaging.
- At least one major native coronary artery eligible for intracoronary imaging immediately after PCI with: angiographic stenosis 6%
- Target vessel accessible to imaging catheter, suitable for imaging in proximal 50 mm segment.
- Target vessel not a bypass graft or bypassed vessel.
- Target vessel has not undergone PCI within the target segment.
- Target vessel is not a candidate for PCI at the time of procedure or for 6 months after per investigator's judgment.
- Provided written informed consent to participate.
You will not qualify if you...
- Left main coronary artery stenosis 50% by angiographic estimation.
- History of coronary artery bypass graft surgery (CABG).
- Unstable clinical condition including hemodynamic or electrical instability.
- Severe coronary artery calcification or tortuosity interfering with imaging.
- Uncontrolled cardiac arrhythmia not controlled by medication within 3 months prior to screening.
- Active liver disease or liver dysfunction.
- Severe renal dysfunction (eGFR <30 mL/min/1.73m).
- Known allergy to contrast media, heparin, aspirin, ticagrelor, or prasugrel.
- Active infection or major hematologic, metabolic, or endocrine dysfunction.
- Planned surgery within 12 months.
- Currently enrolled in another investigational device or drug study.
- Estimated life expectancy less than 2 years.
- Women of childbearing potential under 50 years who had last menstrual period within 12 months and have not had tubal ligation, oophorectomy, or hysterectomy.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Korea University Anam Hospital
Seoul, Seoul, South Korea, 02841
Actively Recruiting
Research Team
S
Soon Jun Hong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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