Comparing Early Combination of Statin and Ezetimibe Versus Statin Alone for Lowering LDL Cholesterol in Adults After Recent Ischemic Stroke with Atherosclerosis

What this Trial Is About

Researchers are evaluating the effects of starting a combination of moderate-intensity statin plus ezetimibe versus moderate- or high-intensity statin alone in patients who recently had an ischemic stroke or transient ischemic attack TIA and have atherosclerosis. This randomized controlled trial aims to determine which treatment better lowers LDL cholesterol levels to below 70 mgdL, with participants recruited within 30 days after their stroke or TIA. The study is conducted across six medical institutions in Taiwan and sponsored by Chang Gung Memorial Hospital. Participants will be randomly assigned to one of two groups the experimental group receiving a fixed-dose combination of statin and ezetimibe such as simvastatin 20mgezetimibe 10mg, atorvastatin 20mgezetimibe 10mg, rosuvastatin 10mgezetimibe 10mg, or ezetimibe added to moderate-intensity statins or the control group receiving moderate- or high-intensity statin monotherapy including atorvastatin 10-80 mgday, rosuvastatin 5-20 mgday, or pitavastatin 1-4 mgday. Treatment starts within 2 days after randomization. During the study, participants will have their LDL cholesterol levels measured at 3 and 6 months after randomization to assess treatment effects. Researchers will monitor LDL-C levels to see if they reach below 70 mgdL, the primary outcome measured at 6 months. Patients will be screened by research assistants and attending physicians for eligibility, and the trial runs until July 2029, involving adults aged 20 to 100 years old who had recent ischemic stroke or TIA with LDL-C levels of 100 mgdL or higher and evidence of atherosclerosis.

Early Statin-Ezetimibe Combination vs. Statin Monotherapy in Stroke With Atherosclerosis