Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT06784557
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT06784557
Study Brief:
Protocol Section:
NCT06784557