Impact of Ezetimibe on Gut Microbiota in Patients with Atherosclerotic Cardiovascular Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.