Background and aims: LDL-C <70 mg/dL is recommended for patients with cerebral ischemia of atherosclerotic origin or atherosclerosis in the cerebral vascular bed. However, many patients do not achieve this goal with statin monotherapy. This trial aimed to assess the target goal achievement rate with adding ezetimibe in these patients.
Methods: This multicenter, open-label, single arm, trial involved 10 centers from South Korea. Key inclusion criteria were 1) ischemic stroke, transient ischemic attack (TIA), or cerebral atherosclerosis without clinical cerebral ischemia, 2) having been on statin monotherapy, and 3) baseline LDL-C levels ≥70mg/dL. Eligible patients received once daily ezetimibe 10 mg plus rosuvastatin dose of 5, 10, or 20 mg which was an equivalent intensity of prior statins.
Results: We enrolled 410 patients between July 31, 2023 and Feb 6, 2024. The mean age was 66.6±10.9, and 37.1% were female. The qualifying event was ischemic stroke in 297 (72.4%), TIA in 43 (10.5%), and cerebral atherosclerosis without clinical cerebral ischemia in 70 (17.1%). Prior statins before enrollment were rosuvastatin 5, 10, and 20 mg or equivalent intensity of other statins in 41.9%, 35.9%, and 22.3%, respectively. The baseline LDL-C level was 94.3±19.7 mg/dL; 23.5% in 70-80 mg/dL, 25.9% in 81-90 mg/dL, 20.1% in 91-100 mg/dL, and 30.1% in >100 mg/dL.
Conclusions: Final results will be presented at the Congress (Funded by Samjin Pharm; Cris.nih.go.kr: KCT0008455).