What this Trial Is About

Researchers are investigating how the drug ezetimibe, which primarily works by blocking cholesterol absorption in the intestines, may affect gut microbiota in patients with coronary artery disease (CAD) and dyslipidemia. This study explores ezetimibe's potential role in modifying gut microbes, which are known to influence cholesterol metabolism and cardiovascular disease through various pathways. The trial is a Phase 4, prospective, open-label, randomized clinical trial conducted at a single center, enrolling 110 CAD patients needing lipid-lowering treatment. Participants are randomly assigned to one of two treatment groups for 12 weeks: one group receives a combination of moderate-intensity atorvastatin (20 mg) plus ezetimibe (10 mg), while the other group receives high-intensity atorvastatin (40 mg) alone. Treatments are taken orally once daily at consistent times regardless of meals. The study includes baseline data collection, a possible 2-week washout period for those previously on statins or ezetimibe, and a follow-up period after 12 weeks of therapy. Throughout the study, participants provide stool samples analyzed by 16S rRNA sequencing to assess changes in gut microbiota composition as the primary outcome. Secondary outcomes include changes in blood lipid levels and inflammatory markers. Additional subgroup analyses focus on patients with varying cardiovascular risks and treatment responses. Clinical evaluations, blood tests, and stool samples are collected at baseline and after treatment to monitor safety and efficacy during the 12-week study period.

Effect of Ezetimibe on Gut Microbiota