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

Phase 4

Recruiting

• Conditions: Coronary Artery Disease; Atherosclerosis of Coronary Artery; Plaque, Atherosclerotic
• Interventions: Drug: statins, ezetimibe; Drug: Combination therapy

• Registration Number: NCT06767345
• Lead Sponsor: Korea University Anam Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-03
• Study First Submitted QC: 2025-01-05
• Study First Posted: 2025-01-09
• Status Verified: 2025-05
• Study Start: 2025-05-12
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2028-01-25
• Study Completion: 2028-06-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Intensity Statin monotherapy	statins, ezetimibe	Rosuvastatin 20mg once a daily
Combination therapy	Combination therapy	Rosuvastatin 10mg plus Ezetimibe 10mg fixed dose single-pill combination

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of