NCT06767345Active, not recruitingPhase 4
Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization
Comparing the Moderate Intensity STatin With Ezetimibe COmbination TheraPy With High Intensity Statin Monotherapy on Coronary PLAQUE Stabilization
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 410 (actual)
- First submitted
- 3 Jan 2025
- Start date
- 12 May 2025
- Primary completion date
- Nov 2027
- Lead sponsor
- Korea University Anam Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT06767345
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 410
- From 12 May 2025 to the primary completion date, Nov 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Planned surgery within 12 months.
- Currently enrolled in another randomized device study or a drug study involving lipid-lowering therapy.
Other illness
- History of coronary artery bypass graft surgery (CABG).
- Unstable clinical condition (hemodynamic or electrical instability).
- 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 as determined by the investigator.
Lab values
- Severe renal dysfunction (eGFR \<30 mL/min/1.73m²)
Age
- 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.
Other
- Left main stem lesion: Left main coronary artery stenosis ≥50% by coronary angiographic visual estimation.
- Severe coronary artery calcification or tortuosity interfering with IVUS, NIRS, or evaluation.
- Estimated life expectancy of less than 2 years.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Inje University Ilsan Paik Hospital Coordinator of this site? Confirm its status | Goyang | South Korea | Unknown status |
| Kyung Hee University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kyung Hee University Hospital at Gangdong Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Hanyang University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Chung ang University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.