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 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT06134635
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with acute ischemic stroke;
* Aged 18-80 years, gender unlimited;
* The fasting LDL-C≥1.8mmol/L (70mg/dL);
* Received lipid-lowering therapy with statins with or without evolocumab;
* Premorbid mRS ≤ 2;
* NIHSS ≤ 15;
* Subjects participated in the study voluntarily and signed informed consent.
Exclusion Criteria:
* Participants who changed their lipid-lowering regimen;
* Participants allergic to PCSK9 inhibitors;
* Participants treated with cholesterol ester transfer protein inhibitor within 12 months prior to enrollment;
* LDL or plasma apheresis within 12 months prior to enrollment；
* Last known left ventricular ejection fraction \< 30%
* Known hemorrhagic stroke at any time；
* Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73m2 at final screening；
* Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times；
* Pregnant or lactating women；
* Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06134635
Study Brief:
Protocol Section:
NCT06134635