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NCT Number: NCT06767345

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

statins, ezetimibe

Drug

Rosuvastatin 20mg once daily

Combination therapy

Drug

Rosuvastatin 10mg + Ezetimibe 10mg

Primary outcomes

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

    Time frame: 52 weeks

Secondary outcomes

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

    Time frame: 52 weeks

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

    Time frame: 52 weeks

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

    Time frame: 52 weeks

Other outcomes

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

    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.

  2. All deaths from baseline to week 52

    Time frame: 52 weeks

  3. Cardiac-related deaths from baseline to week 52

    Time frame: 52 weeks

  4. Nonfatal myocardial infarction from baseline to week 52

    Time frame: 52 weeks

  5. Ischemic Coronary Revascularization From Baseline to Week 52

    Time frame: 52 weeks

  6. Ischemic Stroke/TIA from Baseline to Week 52

    Time frame: 52 weeks

  7. Incidence of new diabetes from baseline to week 52

    Time frame: 52 weeks

  8. Incidence of statin-associated muscle syndrome (SAMS) from baseline to week 52

    Time frame: 52 weeks

  9. Adherence from baseline to week 52 (80% or greater)

    Time frame: 52 weeks

    Proportion of patients achieving ≥80% adherence to prescribed medication from baseline to week 52

  10. Cataract incidence from baseline to 52 weeks

    Time frame: 52 weeks

  11. Changes in hsCRP from baseline to 52 weeks and associations with plaque progression/regression indices

    Time frame: 52 weeks

  12. Changes in hsTnT from baseline to 52 weeks and associations with plaque progression/regression indices

    Time frame: 52 weeks

  13. Changes in NT-pro-BNP from baseline to 52 weeks and associations with plaque progression/regression indices

    Time frame: 52 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Soon Jun Hong

CONTACT

[email protected]

+82-2-920-5445

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Collaborators

  • Hanmi Pharmaceutical co., ltd.
  • Yuhan Corporation

Registry information

Official study title

Comparing the Moderate Intensity STatin With Ezetimibe COmbination TheraPy With High Intensity Statin Monotherapy on Coronary PLAQUE Stabilization

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 9, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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