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Safety and Efficacy of Evolocumab in Ischemic Stroke (SEEIS)

Primary Purpose

Ischemic Stroke, Acute

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Evolocumab
Sponsored by
Second Affiliated Hospital of Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    the evolocumab plus statin therapy

    the statin alone therapy

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Percent change in LDL-C

    Secondary Outcome Measures

    Vascular events
    incidence of Transient ischemic attack, stroke or other vascular events
    mRS (0-2)
    proportion of mRS (0-2)
    death of any causes
    proportion of death

    Full Information

    First Posted
    January 15, 2023
    Last Updated
    January 15, 2023
    Sponsor
    Second Affiliated Hospital of Guangxi Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05697185
    Brief Title
    Safety and Efficacy of Evolocumab in Ischemic Stroke
    Acronym
    SEEIS
    Official Title
    Safety and Efficacy of Evolocumab in in Combination With Statin Therapy in Adults With Ischemic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    February 1, 2024 (Anticipated)
    Study Completion Date
    December 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Second Affiliated Hospital of Guangxi Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Stroke, Acute

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    the evolocumab plus statin therapy
    Arm Type
    Experimental
    Arm Description
    Patients with AIS are treated with atorvastatin (40mg) daily and evolocumab (420 mg) every months throughout the study period
    Arm Title
    the statin alone therapy
    Arm Type
    No Intervention
    Arm Description
    Patients with AIS are treated with atorvastatin (40mg) daily throughout the study period.
    Intervention Type
    Drug
    Intervention Name(s)
    Evolocumab
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Percent change in LDL-C
    Time Frame
    baseline, 4 weeks, 8 weeks, 12 weeks after treatment
    Secondary Outcome Measure Information:
    Title
    Vascular events
    Description
    incidence of Transient ischemic attack, stroke or other vascular events
    Time Frame
    3 months, 6months
    Title
    mRS (0-2)
    Description
    proportion of mRS (0-2)
    Time Frame
    3 months, 6months
    Title
    death of any causes
    Description
    proportion of death
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Junli Liang, PhD
    Phone
    +86-13481138068
    Email
    liangjl80@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Junli Liang, PhD
    Organizational Affiliation
    The Second Affiliated Hospital of Guangxi Medical University, Nanning, China
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy of Evolocumab in Ischemic Stroke

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