Safety and Efficacy of Evolocumab in Ischemic Stroke
SEEIS
1 other identifier
interventional
200
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2023
CompletedFirst Posted
Study publicly available on registry
January 25, 2023
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJanuary 25, 2023
January 1, 2023
1 year
January 15, 2023
January 15, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change in LDL-C
baseline, 4 weeks, 8 weeks, 12 weeks after treatment
Secondary Outcomes (3)
Vascular events
3 months, 6months
mRS (0-2)
3 months, 6months
death of any causes
12 months
Study Arms (2)
the evolocumab plus statin therapy
EXPERIMENTALPatients with AIS are treated with atorvastatin (40mg) daily and evolocumab (420 mg) every months throughout the study period
the statin alone therapy
NO INTERVENTIONPatients with AIS are treated with atorvastatin (40mg) daily throughout the study period.
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Qiu X, Liang Y, Wei Y, Lu M, Mei Y, Tang S, Tang J, Liang J, Liang J. Evolocumab for early reduction of LDL-C levels in patients with acute ischemic stroke: a randomized controlled trial. Front Neurol. 2024 Dec 23;15:1454608. doi: 10.3389/fneur.2024.1454608. eCollection 2024.
PMID: 39764289DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Junli Liang, PhD
The Second Affiliated Hospital of Guangxi Medical University, Nanning, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 15, 2023
First Posted
January 25, 2023
Study Start
February 1, 2023
Primary Completion
February 1, 2024
Study Completion
December 1, 2024
Last Updated
January 25, 2023
Record last verified: 2023-01