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

October 22, 2026 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 change in percent atheroma volume (PAV) from baseline to week 52, assessed by grayscale IVUS. Secondary outcomes include changes in lipid core burden, inflammatory markers, and clinical events like myocardial infarction and ischemic stroke. Seven hospitals participated in the study. A total of 410 participants were enrolled at six sites; no participants were enrolled at Inje University Ilsan Paik Hospital. Follow-up is ongoing.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
410

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • South Korea
      • Goyang, South Korea, 10380
        • Inje University Ilsan Paik Hospital
      • Seoul, South Korea, 05278
        • Kyung Hee University Hospital at Gangdong
      • Seoul, South Korea, 02447
        • Kyung Hee University Hospital
      • Seoul, South Korea, 06973
        • Chung-Ang University Hospital
      • Seoul, South Korea, 04763
        • Hanyang University Hospital
      • Suwon, South Korea, 16499
        • Ajou University Hospital
    • Seoul
      • Seoul, Seoul, South Korea, 02841
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult men and women aged 18 years or older.

  • 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 (saphenous vein 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 randomized device study or a drug study involving lipid-lowering therapy.

  • 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: High Intensity Statin monotherapy

Rosuvastatin 20 mg once daily
Drug: Rosuvastatin

Rosuvastatin 20mg once daily
Experimental: Combination therapy

Rosuvastatin 10mg plus Ezetimibe 10mg fixed dose single-pill combination
Drug: Rosuvastatin/ezetimibe

Rosuvastatin 10mg + Ezetimibe 10mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in percent atheroma volume (PAV) from baseline to week 52, assessed by gray-scale IVUS
Time Frame: 52 weeks

Percent atheroma volume (PAV) is calculated within matched coronary-artery regions of interest as 100 × Σ(EEM CSA - lumen CSA)/Σ(EEM CSA), where EEM CSA is the external elastic membrane cross-sectional area and lumen CSA is the lumen cross-sectional area. Change in PAV between baseline and week 52 is assessed by gray-scale IVUS.
52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
Change from baseline to week 52 in total lipid core burden index measured by NIRS (LCBItotal)
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
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. Blood samples will be collected at baseline and after 52 weeks.
52 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Korea University Anam Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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