Safety and Efficacy of Evolocumab in Ischemic Stroke

Second Affiliated Hospital of Guangxi Medical University200 enrolled

Overview

The goal of this clinical trial is to evaluate the effect of evolocumab in combination with statin therapy (atorvastatin) in acute ischemic stroke (AIS).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Ischemic Stroke, Acute

Interventions

EvolocumabDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percent change in LDL-C

Time frame: baseline, 4 weeks, 8 weeks, 12 weeks after treatment

Secondary Outcomes

Vascular events

incidence of Transient ischemic attack, stroke or other vascular events

Time frame: 3 months, 6months

mRS (0-2)

proportion of mRS (0-2)

Time frame: 3 months, 6months

death of any causes

proportion of death

Time frame: 12 months

Central Contacts

Junli Liang, PhD

CONTACT

+86-13481138068 liangjl80@163.com

Data from ClinicalTrials.gov

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