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 @ 12:18 PM
Ignite Modification Date:
2025-12-24 @ 12:18 PM
NCT ID:
NCT06641661
Eligibility Criteria:
Inclusion Criteria:
1. Patients with high/very high risk of ASCVD were only treated with moderate intensity statins (including atorvastatin 10-20mg, rosuvastatin 5-10mg, fluvastatin 80mg, lovastatin 40mg, pivastatin 1-4mg, pravastatin 40mg, simvastatin 20-40mg, etc.) for at least 8 weeks before enlistment.
2. The LDL-C level did not meet the lipid reduction target corresponding to the risk stratification level of ASCVD recommended by the Chinese Lipid Management Guidelines (2023), or the level of LDL-C was still not up to the standard as clinicians expected that patients should continue to use medium-dose statins for lipid-lowering treatment alone, and the cholesterol absorption inhibitor Hybomab should be combined;
3. Age 18-75 years old;
4. BMI range 22-45 kg/m2;
5. Can understand and voluntarily sign informed consent.
Exclusion Criteria:
1. Allergic history of cholesterol absorption inhibitors and statins;
2. other types of cholesterol absorption inhibitors have been used;
3. Homozygous familial hypercholesterolemia;
4. any clinically serious endocrine disease affecting blood lipids or lipid proteins;
5. Abnormal liver function with AST or ALT greater than three times the upper limit of normal, or bilirubin \>34uM, creatine muscle enzyme greater than five times the upper limit of normal, or evidence of serologically infectious liver disease;
6. Thyroid dysfunction;
7. History of malignant tumor;
8. Patients with coagulation dysfunction;
9. Women who are pregnant or planning to become pregnant;
10. Taking fenofibrate, gefilozil, probucol, warfarin, glucocorticoids, cyclosporine or another immunosuppressant within 30 days prior to the trial;
11. can not adhere to medication or regular follow-up;
12. Communication disorders, people with severe aphasia, audio-visual impairment, serious mental illness, and difficulty cooperating with investigators;
13. There are other circumstances that the researcher considers inappropriate to participate in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06641661
Study Brief:
Protocol Section:
NCT06641661