Atherosclerosis of Coronary Artery, Coronary Artery Disease, Plaque, Atherosclerotic
Conditions
Brief 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 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.
Interventions
Rosuvastatin 20mg once daily
DRUGCombination therapy
Rosuvastatin 10mg + Ezetimibe 10mg
Sponsors
Yuhan Corporation
Hanmi Pharmaceutical co., ltd.
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 (target vessel) meeting all the following criteria for intracoronary imaging immediately following a qualifying PCI procedure: * 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. * Target vessel is not a bypass graft (aortic or arterial) or a bypassed graft vessel. * Target vessel has not undergone PCI within the target segment. * Target vessel is not a candidate for PCI at the time of the procedure or for 6 months thereafter (per investigator's judgment). * Patients who have provided written informed consent to participate in the study.
Exclusion criteria
* 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. * Uncontrolled cardiac arrhythmia (recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response) not controlled by medication within 3 months prior to screening. * Active liver disease or liver dysfunction. * Severe renal dysfunction (eGFR \<30 mL/min/1.73m²) * Known allergy to contrast media, heparin, aspirin, ticagrelor, or prasugrel. * Active infection or major hematologic, metabolic, or endocrine dysfunction as determined by the investigator. * Planned surgery within 12 months. * Currently enrolled in another investigational device or drug study. * Estimated life expectancy of less than 2 years. * Women of childbearing potential (under 50 years of age) who: * Had their last menstrual period within the last 12 months. * Have not had tubal ligation, oophorectomy, or hysterectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage change in coronary atheroma volume (PAV) by gray-scale IVUS from baseline to week 52. | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to week 52 in total lipid core BMI measured by NIRS (LCBItotal) | 52 weeks |
| Change in maximum LCBI within a 4-mm bin measured by NIRS from baseline to week 52 (maxLCBI4mm) | 52 weeks |
| Change in corrected total atherosclerotic plaque volume (NTAV) measured by IVUS from baseline to week 52 | 52 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ischemic Coronary Revascularization From Baseline to Week 52 | 52 weeks | — |
| Ischemic Stroke/TIA from Baseline to Week 52 | 52 weeks | — |
| Incidence of new diabetes from baseline to week 52 | 52 weeks | — |
| Incidence of statin-associated muscle syndrome (SAMS) from baseline to week 52 | 52 weeks | — |
| Changes in LDL-cholesterol from baseline to 52 weeks and associations with plaque progression/regression indices | 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. |
| Cataract incidence from baseline to 52 weeks | 52 weeks | — |
| Changes in hsCRP from baseline to 52 weeks and associations with plaque progression/regression indices | 52 weeks | — |
| Changes in hsTnT from baseline to 52 weeks and associations with plaque progression/regression indices | 52 weeks | — |
| Changes in NT-pro-BNP from baseline to 52 weeks and associations with plaque progression/regression indices | 52 weeks | — |
| Adherence from baseline to week 52 (80% or greater) | 52 weeks | Proportion of patients achieving ≥80% adherence to prescribed medication from baseline to week 52 |
| All deaths from baseline to week 52 | 52 weeks | — |
| Cardiac-related deaths from baseline to week 52 | 52 weeks | — |
| Nonfatal myocardial infarction from baseline to week 52 | 52 weeks | — |
Countries
South Korea
Contacts
Primary ContactSoon Jun Hong
Outcome results
None listed