Comparing the Moderate Intensity STatin With Ezetimibe COmbination TheraPy With High Intensity Statin Monotherapy on Coronary PLAQUE Stabilization
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.
• 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.