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

Korea University

Status and phase: Enrolling; Phase 4

Conditions: Coronary Artery Disease; Atherosclerosis of Coronary Artery; Plaque, Atherosclerotic

Treatments: Drug: Combination therapy; Drug: statins, ezetimibe

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06767345

STOP-PLAQUE

Details and patient eligibility

About

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.

Enrollment: 408 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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408 participants in 2 patient groups

High Intensity Statin monotherapy

Active Comparator group

Description:

Rosuvastatin 20mg once a daily

Treatment:

Drug: statins, ezetimibe

Combination therapy

Experimental group

Description:

Rosuvastatin 10mg plus Ezetimibe 10mg fixed dose single-pill combination

Treatment:

Drug: Combination therapy