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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT01697735
Eligibility Criteria:
Inclusion Criteria:
1. Current use of lipid-lowering medications;
2. Documented cardiovascular disease (CVD) by invasive or non-invasive testing (such as coronary angiography, nuclear imaging, stress echocardiography, carotid plaque on ultrasound), previous myocardial infarction (MI), acute coronary syndrome (ACS), coronary revascularization \[percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)\] and other arterial revascularization procedures, ischaemic stroke, peripheral arterial disease(PAD);
3. Patients with type 2 diabetes, patients with type 1 diabetes with target organ damage (such as microalbuminuria); Patients with moderate to severe chronic kidney disease \[glomerular filtration rate (GFR) \< 60 mL/min/1.73㎡\];
4. Markedly elevated single risk factors such as familial dyslipidaemias and severe hypertension;
5. A calculated SCORE ≥1% for 10 year risk of fatal CVD
Exclusion Criteria:
1. Cancer;
2. HIV infected;
3. Medical or psychiatric condition that prevents full study participation or follow-up (e.g., active psychosis);
4. Active liver disease or unexplained persistent elevated transaminase levels；
5. Major surgery or hospitalization in the 3 months prior to study entry;
6. Current use of cyclosporin, erythromycin, clarithromycin, nefazodone, or any "azole" antifungals, including fluconazole, itraconazole, ketoconazole, mibefradil, or protease inhibitors;
7. Female of childbearing potential;
8. Severe gastrointestinal disease;
9. With berberine using contraindications;
10. Secondary hyperlipidemia
11. Current participation in another clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT01697735
Study Brief:
Protocol Section:
NCT01697735