Clinical trial NCT06767345: Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization
Official title: Comparing the Moderate Intensity STatin With Ezetimibe COmbination TheraPy With High Intensity Statin Monotherapy on Coronary PLAQUE Stabilization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Coronary Artery Disease
Atherosclerosis of Coronary Artery
Plaque, Atherosclerotic
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: Yuhan Corporation
name: Hanmi Pharmaceutical co., ltd.
First posted: 2025-01-09
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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), 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 330 patients undergoing coronary intervention across 9 domestic institutions, with rigorous follow-up protocols and adherence to international research guidelines.


Eligibility criteria: 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.
* 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.

Primary outcomes:
measure: percentage change in coronary atheroma volume (PAV) by gray-scale IVUS from baseline to week 52.
timeFrame: 52 weeks
Secondary outcomes:
measure: Change from baseline to week 52 in total lipid core BMI measured by NIRS (LCBItotal)
timeFrame: 52 weeks
measure: Change in maximum LCBI within a 4-mm bin measured by NIRS from baseline to week 52 (maxLCBI4mm)
timeFrame: 52 weeks
measure: Change in corrected total atherosclerotic plaque volume (NTAV) measured by IVUS from baseline to week 52
timeFrame: 52 weeks
Other outcomes:
measure: Changes in LDL-cholesterol from baseline to 52 weeks and associations with plaque progression/regression indices
timeFrame: 52 weeks
measure: All deaths from baseline to week 52
timeFrame: 52 weeks
measure: Cardiac-related deaths from baseline to week 52
timeFrame: 52 weeks
measure: Nonfatal myocardial infarction from baseline to week 52
timeFrame: 52 weeks
measure: Ischemic Coronary Revascularization From Baseline to Week 52
timeFrame: 52 weeks
measure: Ischemic Stroke/TIA from Baseline to Week 52
timeFrame: 52 weeks
measure: Incidence of new diabetes from baseline to week 52
timeFrame: 52 weeks
measure: Incidence of statin-associated muscle syndrome (SAMS) from baseline to week 52
timeFrame: 52 weeks
measure: Adherence from baseline to week 52 (80% or greater)
timeFrame: 52 weeks
measure: Cataract incidence from baseline to 52 weeks
timeFrame: 52 weeks
measure: Changes in hsCRP from baseline to 52 weeks and associations with plaque progression/regression indices
timeFrame: 52 weeks
measure: Changes in hsTnT from baseline to 52 weeks and associations with plaque progression/regression indices
timeFrame: 52 weeks
measure: Changes in NT-pro-BNP from baseline to 52 weeks and associations with plaque progression/regression indices
timeFrame: 52 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References:
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