Comparing two treatments for stabilizing coronary plaques
Comparing the Moderate Intensity STatin With Ezetimibe COmbination TheraPy With High Intensity Statin Monotherapy on Coronary PLAQUE Stabilization
PHASE4 · Korea University Anam Hospital · NCT06767345
This study is testing whether a combination of a moderate-intensity statin and ezetimibe works better than a high-intensity statin alone to stabilize coronary plaques in patients with coronary artery disease.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 408 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Korea University Anam Hospital (other) |
| Locations | 1 site (Seoul, Seoul) |
| Trial ID | NCT06767345 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multicenter, randomized study that compares the effectiveness of a moderate-intensity statin combined with ezetimibe against a high-intensity statin alone in stabilizing coronary plaques in patients with coronary artery disease. The trial utilizes advanced imaging techniques, specifically near-infrared spectroscopy-intravascular ultrasound (NIRS-IVUS), to assess changes in coronary atheroma volume over a 52-week period. It aims to enroll 330 patients undergoing coronary interventions and will monitor various secondary outcomes, including lipid core burden and clinical events such as myocardial infarction. The study adheres to rigorous follow-up protocols and international research guidelines.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with coronary artery disease who are undergoing a coronary intervention procedure.
Not a fit: Patients with left main stem lesions or those who have had recent PCI procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for stabilizing coronary plaques, potentially reducing the risk of heart attacks and strokes.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific combination therapy is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul, Seoul
- Korea University Anam Hospital — Seoul, Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: Soon Jun Hong
- Email: psyche94@gmail.com
- Phone: +82-2-920-5445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, Atherosclerosis of Coronary Artery, Plaque, Atherosclerotic