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

September 8, 2025 updated by: Soon Jun Hong, Korea University Anam Hospital

Comparing the Moderate Intensity STatin With Ezetimibe COmbination TheraPy With High Intensity Statin Monotherapy on 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

408

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea, 02841
        • Recruiting
        • Korea University Anam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High Intensity Statin monotherapy
Rosuvastatin 20mg once a daily
Drug: statins, ezetimibe
Rosuvastatin 20mg once daily
Experimental: Combination therapy
Rosuvastatin 10mg plus Ezetimibe 10mg fixed dose single-pill combination
Drug: Combination therapy
Rosuvastatin 10mg + Ezetimibe 10mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage change in coronary atheroma volume (PAV) by gray-scale IVUS from baseline to week 52.
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to week 52 in total lipid core BMI measured by NIRS (LCBItotal)
Time Frame: 52 weeks
52 weeks
Change in maximum LCBI within a 4-mm bin measured by NIRS from baseline to week 52 (maxLCBI4mm)
Time Frame: 52 weeks
52 weeks
Change in corrected total atherosclerotic plaque volume (NTAV) measured by IVUS from baseline to week 52
Time Frame: 52 weeks
52 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
52 weeks
All deaths from baseline to week 52
Time Frame: 52 weeks
52 weeks
Cardiac-related deaths from baseline to week 52
Time Frame: 52 weeks
52 weeks
Nonfatal myocardial infarction from baseline to week 52
Time Frame: 52 weeks
52 weeks
Ischemic Coronary Revascularization From Baseline to Week 52
Time Frame: 52 weeks
52 weeks
Ischemic Stroke/TIA from Baseline to Week 52
Time Frame: 52 weeks
52 weeks
Incidence of new diabetes from baseline to week 52
Time Frame: 52 weeks
52 weeks
Incidence of statin-associated muscle syndrome (SAMS) from baseline to week 52
Time Frame: 52 weeks
52 weeks
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
52 weeks
Cataract incidence from baseline to 52 weeks
Time Frame: 52 weeks
52 weeks
Changes in hsCRP from baseline to 52 weeks and associations with plaque progression/regression indices
Time Frame: 52 weeks
52 weeks
Changes in hsTnT from baseline to 52 weeks and associations with plaque progression/regression indices
Time Frame: 52 weeks
52 weeks
Changes in NT-pro-BNP from baseline to 52 weeks and associations with plaque progression/regression indices
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Anam Hospital

Collaborators

Yuhan Corporation
Hanmi Pharmaceutical co., ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2025

Primary Completion (Estimated)

January 25, 2028

Study Completion (Estimated)

June 25, 2028

Study Registration Dates

First Submitted

January 3, 2025

First Submitted That Met QC Criteria

January 5, 2025

First Posted (Actual)

January 9, 2025

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STOP-PLAQUE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on statins, ezetimibe

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe