Safety and Efficacy of Evolocumab in Ischemic Stroke (SEEIS)

Second Affiliated Hospital of Guangxi Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Ischemic Stroke, Acute

Treatments: Drug: Evolocumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05697185

KY-0012

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

the evolocumab plus statin therapy

Experimental group

Description:

Patients with AIS are treated with atorvastatin (40mg) daily and evolocumab (420 mg) every months throughout the study period

Treatment:

Drug: Evolocumab

the statin alone therapy

No Intervention group

Description:

Patients with AIS are treated with atorvastatin (40mg) daily throughout the study period.