Impact of Ezetimibe on Gut Microbiota in Patients with Atherosclerotic Cardiovascular Disease
Gut Microbiota Alteration With Atorvastatin/Ezetimibe Combination in Patients With Atherosclerotic Cardiovascular Disease
This study is testing if adding Ezetimibe to a statin treatment can change the gut bacteria in people with heart disease and high cholesterol.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06784557 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Ezetimibe on gut microbiota composition in patients with atherosclerotic cardiovascular disease and dyslipidemia. It is a 12-week, open-label, randomized study involving 110 participants who will be divided into two groups: one receiving a combination of moderate-intensity statin and Ezetimibe, and the other receiving high-intensity statin therapy alone. The primary outcome is to assess changes in gut microbiota, while secondary outcomes include blood lipid levels and inflammatory biomarkers. The study aims to explore the potential interactions between Ezetimibe and gut microbial communities and their implications for cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 80 with diagnosed coronary artery disease requiring lipid-lowering therapy.
Not a fit: Patients with active liver disease, allergies to the study medications, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how Ezetimibe may improve cardiovascular health by modulating gut microbiota.
How similar studies have performed: While the specific impact of Ezetimibe on gut microbiota is not well-studied, similar approaches in modulating gut microbiota for cardiovascular health have shown promise in other research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 19 to 80 years old * Criteria for Diagnosis of Coronary Artery Disease: Patients diagnosed with coronary artery disease through coronary angiography, or Patients who require high-intensity lipid-lowering therapy according to current guidelines: Clinical atherosclerotic cardiovascular disease, LDL cholesterol ≥ 190 mg/dL, LDL 70-189 mg/dL in diabetic patients, 10-year calculated atherosclerotic cardiovascular disease risk ≥ 7.5% \- Voluntary Consent: Individuals who have voluntarily agreed to participate in the study and signed the consent form. Exclusion Criteria: * Patients with active liver disease or liver disease with AST/ALT levels elevated more than twice the upper limit of normal. * Individuals with allergies or hypersensitivity to HMG-CoA reductase inhibitors or ezetimibe. * Individuals with a history of adverse reactions to HMG-CoA reductase inhibitors or ezetimibe. * Pregnant, breastfeeding, or women of childbearing potential. * Organ transplant recipients or individuals scheduled for organ transplantation. * Patients with active malignant tumors. * Patients with inflammatory bowel disease. * Patients with wasting diseases, autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis), or connective tissue diseases (e.g., systemic sclerosis, polymyositis, and dermatomyositis). * Patients with a history of taking antibiotics, probiotics, or ezetimibe within 3 months prior to study screening. * Patients who have undergone gastrointestinal surgery within the past year. * Patients who do not understand the study content or are unable to provide consent.
Where this trial is running
Seoul
- Severance hospital, Yonsei University College of Medicine — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: jong won ha, MD,PhD
- Email: jwha@yuhs.ac
- Phone: 82-2-2228-8460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.