Status:
UNKNOWN
Short-term Effect of PCSK9 Inhibitor in Patients With Acute Ischemic Stroke
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-80 years
Brief Summary
This is a prospective cohort study to investigate the early impact of evolocumab on patients with acute ischemic stroke (AIS) in China. Evolocumab, a proprotein convertase subtilisin/kexin taye 9 inhi...
Detailed Description
Patients aged 18-80 years old admitted to the Department of Neurology, Xuanwu Hospital, Capital Medical University, with a definite diagnosis of acute ischemic stroke and receiving lipid-lowering ther...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06134635
Start Date
December 1 2023
End Date
December 1 2024
Last Update
November 18 2023
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