Switch to Rosuvastatin Plus Ezetimibe From Statin Monotherapy to Achieve Target LDL-Cholesterol Goal: A Multi-Center, Open-Label, Single-Arm Trial

For patients with cerebrovascular disease of atherosclerotic origin, the target low-density lipoprotein cholesterol (LDL-C) level is less than 70 mg/dL. 1However, despite being on statin monotherapy, approximately 50% of patients fail to achieve the target LDL-C goal. 2,3Further LDL-C reduction by increasing statin dosage is limited; doubling the statin dose generally results in only a 5% to 7% absolute reduction.Recent clinical trials involving patients with atherosclerotic cardiovascular disease or recent stroke demonstrated the superiority of the rosuvastatin/ezetimibe combination therapy over doubling rosuvastatin dose for LDL-C reduction. 4,5However, there is no salient data on achieving target LDL-C goals by adding ezetimibe in Korean patients with ischemic stroke, transient ischemic attack (TIA), or cerebral atherosclerosis who were indicated for and have been on statin monotherapy.Switch to ROSuvastatin plus Ezetimibe Treatment from statin monotherapy for Target LDL-C goal Achievement in patients with ischemic STROKE, TIA, or cerebral atherosclerosis (S-ROSETTA-Stroke) aimed to evaluate the effectiveness of switch-ing to combination of ezetimibe and rosuvastatin with equivalent prior statin intensity on achieving LDL-C <70 mg/dL in patients with ischemic stroke, TIA, or cerebrovascular atherosclerosis whose LDL-C was 70 mg/dL despite statin monotherapy.This was an investigator-initiated, multicenter, open-label, single-arm trial conducted in 10 centers in South Korea.The trial was supported by Samjin Pharm, which provided study medications but had no role in the trial's design, conduct, data collection, analysis, interpretation of data, or preparation of the manuscript.All data were collected by site investigators and monitored by an independent research organization contracted by the principal investigator's academic institution.The trial was registered at cris.nih.go.kr (KCT0008455).Key inclusion criteria were (1) ischemic stroke, TIA, or cerebral atherosclerosis without clinical cerebral ischemia, (2) statin monotherapy before enrollment, and (3) baseline LDL-C level >70 mg/dL.Detailed inclusion and exclusion criteria are described in the Supplementary Table 1.The local institutional review boards of all participating centers approved the study.