Safety and Efficacy of Evolocumab in Ischemic Stroke
- Registration Number
- NCT05697185
- Lead Sponsor
- Second Affiliated Hospital of Guangxi Medical University
- Brief Summary
The goal of this clinical trial is to evaluate the effect of evolocumab in combination with statin therapy (atorvastatin) in acute ischemic stroke (AIS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Patient age between 18-80 years
- Time of onset: within 1 week
- NIHSS score ≤12
- Acute ischemic stroke confirmed by head CT or MRI
- Premorbid mRS ≤1
- Signed informed consent
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Exclusion Criteria
- Intracranial hemorrhage found by head CT
- Severe hepatic or renal dysfunction
- Pregnant females
- Abnormal elevation of creatine phosphokinase
- Blood sugar is out of control
- Receiving statins within 1 month before onset
- Not willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures
- Unsuitable for this clinical studies assessed by researcher
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description the evolocumab plus statin therapy Evolocumab Patients with AIS are treated with atorvastatin (40mg) daily and evolocumab (420 mg) every months throughout the study period
- Primary Outcome Measures
Name Time Method Percent change in LDL-C baseline, 4 weeks, 8 weeks, 12 weeks after treatment
- Secondary Outcome Measures
Name Time Method Vascular events 3 months, 6months incidence of Transient ischemic attack, stroke or other vascular events
mRS (0-2) 3 months, 6months proportion of mRS (0-2)
death of any causes 12 months proportion of death