NCT06767345 Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization
| NCT ID | NCT06767345 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Korea University Anam Hospital |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 408 participants |
| Start Date | 2025-05-12 |
| Primary Completion | 2028-01-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 408 participants in total. It began in 2025-05-12 with a primary completion date of 2028-01-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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) 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06767345 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06767345 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06767345 currently recruiting?
Yes, NCT06767345 is actively recruiting participants. Contact the research team at psyche94@gmail.com for enrollment information.
Where is the NCT06767345 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06767345 clinical trial?
NCT06767345 is sponsored by Korea University Anam Hospital. The trial plans to enroll 408 participants.