Ischemic Stroke, Acute
Conditions
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).
Interventions
DRUGEvolocumab
Patients were randomly assigned of the ratio of 1:1 using a computer-generated random number and divided into two treatment groups: the statin alone therapy and the evolocumab plus statin therapy.
Sponsors
Second Affiliated Hospital of Guangxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient age between 18-80 years 2. Time of onset: within 1 week 3. NIHSS score ≤12 4. Acute ischemic stroke confirmed by head CT or MRI 5. Premorbid mRS ≤1 6. Signed informed consent
Exclusion criteria
1. Intracranial hemorrhage found by head CT 2. Severe hepatic or renal dysfunction 3. Pregnant females 4. Abnormal elevation of creatine phosphokinase 5. Blood sugar is out of control 6. Receiving statins within 1 month before onset 7. Not willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures 8. Unsuitable for this clinical studies assessed by researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in LDL-C | baseline, 4 weeks, 8 weeks, 12 weeks after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactJunli Liang, PhD
Outcome results
None listed