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

ConditionsCoronary Artery Disease Atherosclerosis of Coronary Artery Plaque, Atherosclerotic

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorKorea University Anam Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult men and women over the age of 18 years.

Patients with coronary artery disease undergoing a coronary intervention procedure using intravascular imaging.

Angiographic evidence of coronary artery stenosis ≥30% by angiographic visual estimation.

Target vessel is accessible to the imaging catheter and suitable for intracoronary imaging in the proximal 50 mm segment.

Disqualifiers

Left main stem lesion: Left main coronary artery stenosis ≥50% by coronary angiographic visual estimation.

History of coronary artery bypass graft surgery (CABG).

Unstable clinical condition (hemodynamic or electrical instability).

Severe coronary artery calcification or tortuosity interfering with IVUS, NIRS, or evaluation.

Trial design

Design model

Parallel

Treatments tested in this trial

statins, ezetimibe
Drug
Rosuvastatin 20mg once daily
Combination therapy
Drug
Rosuvastatin 10mg + Ezetimibe 10mg

Treatment groups

408 Participants

are divided into 2 treatment groups

Group A: High Intensity Statin monotherapyActive comparator 1 intervention

Group B: Combination therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

percentage change in coronary atheroma volume (PAV) by gray-scale IVUS from baseline to week 52.

Time frame

52 weeks

Secondary outcomes

Change from baseline to week 52 in total lipid core BMI measured by NIRS (LCBItotal)

Time frame

52 weeks

Change in maximum LCBI within a 4-mm bin measured by NIRS from baseline to week 52 (maxLCBI4mm)

Time frame

52 weeks

Change in corrected total atherosclerotic plaque volume (NTAV) measured by IVUS from baseline to week 52

Time frame

52 weeks

Other outcomes

Changes in LDL-cholesterol from baseline to 52 weeks and associations with plaque progression/regression indices

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

All deaths from baseline to week 52

Time frame

52 weeks

Cardiac-related deaths from baseline to week 52

Time frame

52 weeks

Nonfatal myocardial infarction from baseline to week 52

Time frame

52 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Korea University Anam Hospital

Lead sponsor

Yuhan Corporation

Collaborator

Hanmi Pharmaceutical co., ltd.

Collaborator

Source ClinicalTrials.gov

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