Korea University Anam Hospital
Seoul, 02841, South Korea
Location status: Recruiting
NCT Number: NCT06767345
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Seoul, 02841, South Korea
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Rosuvastatin 20mg once daily
Rosuvastatin 10mg + Ezetimibe 10mg
Time frame: 52 weeks
Time frame: 52 weeks
Time frame: 52 weeks
Time frame: 52 weeks
Time frame: 52 weeks
LDL-cholesterol levels measured in mg/dL using [specific lab assay name]. Blood samples will be collected at baseline and after 52 weeks.
Time frame: 52 weeks
Time frame: 52 weeks
Time frame: 52 weeks
Time frame: 52 weeks
Time frame: 52 weeks
Time frame: 52 weeks
Time frame: 52 weeks
Time frame: 52 weeks
Proportion of patients achieving ≥80% adherence to prescribed medication from baseline to week 52
Time frame: 52 weeks
Time frame: 52 weeks
Time frame: 52 weeks
Time frame: 52 weeks
Contact information is provided by the study sponsor or research team.
Korea University Anam Hospital
Other
Comparing the Moderate Intensity STatin With Ezetimibe COmbination TheraPy With High Intensity Statin Monotherapy on Coronary PLAQUE Stabilization
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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