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

Last updated: May 12, 2025
Sponsor: Korea University Anam Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Chest Pain

Atherosclerosis

Myocardial Ischemia

Treatment

statins, ezetimibe

Combination therapy

Clinical Study ID

NCT06767345
STOP-PLAQUE
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Adult men and women over the age of 18 years.

  • Patients with coronary artery disease undergoing a coronary intervention procedureusing intravascular imaging.

  • At least one major native coronary artery ("target vessel") meeting all thefollowing criteria for intracoronary imaging immediately following a qualifying PCIprocedure:

  • Angiographic evidence of coronary artery stenosis ≥30% by angiographic visualestimation.

  • Target vessel is accessible to the imaging catheter and suitable forintracoronary imaging in the proximal 50 mm segment.

  • Target vessel is not a bypass graft (aortic or arterial) or a bypassed graftvessel.

  • 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 6months thereafter (per investigator's judgment).

  • Patients who have provided written informed consent to participate in the study.

Exclusion

Exclusion Criteria:

  • Left main stem lesion: Left main coronary artery stenosis ≥50% by coronaryangiographic 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, orevaluation.

  • Uncontrolled cardiac arrhythmia (recurrent and symptomatic ventricular tachycardiaor atrial fibrillation with rapid ventricular response) not controlled by medicationwithin 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 asdetermined 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

Total Participants: 330
Treatment Group(s): 2
Primary Treatment: statins, ezetimibe
Phase: 4
Study Start date:
May 12, 2025
Estimated Completion Date:
June 25, 2028

Connect with a study center

  • Korea University Anam Hospital

    Seoul, 02841
    Korea, Republic of

    Active - Recruiting

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