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Safety and Efficacy Study of Levofloxacin Combined With Endovascular Thrombectomy for Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Levofloxacin
Levofloxacin simulant
Sponsored by
Yi Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Endovascular thrombectomy, Levofloxacin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-65 years. Patients with clinically confirmed acute ischemic stroke, CTA or DSA confirmed anterior circulation large vessel occlusion (ICA, M1/proximal M2 segment of MCA, tandem lesions), received emergency thrombectomy and successful recanalization (mTICI≥2b). mRS≤2 before stroke onset. Signed and dated informed consent is obtained. Levofloxacin/simulant treatment initiated with in 24h of endovascular thrombectomy. Exclusion Criteria: Patients using glucocorticoids, antiarrhythmic drugs (class I and class III antiarrhythmic drugs: quinidine, procaine amine, lidocaine, phenytoin sodium, verapamil, etc.), and quinolones within 14 days; Patients with other diseases that may aggravate adverse drug reactions, such as ventricular arrhythmias, prolonged QT interval (male: QTc>430ms, female: QTc>450ms), severe cardiac insufficiency (NYHA functional grade ≥ III), myasthenia gravis, peripheral neuropathy, seizures, tendon-related diseases, severe immune system-related diseases, hematological diseases, active hepatitis or cirrhosis, serious respiratory diseases; Abnormal liver and kidney function: glutamic oxaloacetic transaminase or glutamic pyruvic transaminase exceeds 3 times the upper limit of normal; Direct bilirubin or indirect bilirubin more than 3 times the normal upper limit; Blood creatinine exceeds 1.1 times the upper limit of normal; Creatinine clearance rate≤50ml/min; Urea nitrogen≥ 20mg/dL; Ion disorders: hyponatremia (Na<130mmol/L), hypokalemia (K<3.5mmol/L), hyperkalemia (K>5.5mmol/L); Fasting blood glucose lower than 3.9 mmol/L; Patients with symptomatic intracranial hemorrhage confirmed by clinical signs and imaging before randomization; Patients allergy to fluoroquinolones or other antibiotics; Patients with a life expectancy less than 3 months or patients unable to complete the study for other reasons; Not willing to be followed up or poor treatment compliance; Patients who are participating in other clinical studies, or have participated in other clinical studies within 3 months before enrollment, or have participated in this study; Other conditions not suitable for enrollment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Levofloxacin group

    Levofloxacin simulant group

    Arm Description

    Levofloxacin 200mg twice per day is administrated.

    Levofloxacin simulant 200mg twice per day is administrated.

    Outcomes

    Primary Outcome Measures

    National Institute of Health stroke scale (NIHSS) after 3 days of Levofloxacin/simulant treatment
    National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.
    NIHSS at discharge/7 days
    National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.

    Secondary Outcome Measures

    Hemorrhagic transformation and symptomatic intracranial hemorrhage
    defined by computed Tomography (CT) brain scan suggested bleeding, accompanied by an increase in National Institute of Health stroke scale (NIHSS) score of ≥4 points.
    Infarct volume after 3 days of Levofloxacin/simulant treatment
    assessed by magnetic resonance imaging brain scan
    Modified rankin scale (mRS) score at 30 days
    Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome.
    mRS score at 90 days
    Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome.

    Full Information

    First Posted
    February 6, 2023
    Last Updated
    February 14, 2023
    Sponsor
    Yi Yang
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05743101
    Brief Title
    Safety and Efficacy Study of Levofloxacin Combined With Endovascular Thrombectomy for Acute Ischemic Stroke
    Official Title
    Safety and Efficacy Study of Levofloxacin Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 13, 2023 (Anticipated)
    Primary Completion Date
    February 14, 2024 (Anticipated)
    Study Completion Date
    May 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Yi Yang

    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 purpose of this study is to determine the efficacy and safety of levofloxacin combined with endovascular thrombectomy in treating acute ischemic stroke due to large vessel occlusion of anterior circulation.
    Detailed Description
    Acute ischemic stroke is a leading cause of disability and mortality. Emergency thrombectomy is the highest recommended treatment for patients with large vessel occlusion. However, there are still some patients with severe disability or mortality within 90 days after surgery. It is necessary to find new interventions combined to endovascular thrombectomy, which promote the efficacy of endovascular thrombectomy. The investigators' previous studies suggested levofloxacin to be a newly identified neuro-protective agent, which could reduce infarct volume and improve neurologic function in animal models.To evaluate the efficacy and safety of levofloxacin combined with endovascular thrombectomy in treating acute ischemic stroke patients due to large vessel occlusion of anterior circulation, the prospective, multicenter and randomized controlled trial was designed.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Levofloxacin group
    Arm Type
    Experimental
    Arm Description
    Levofloxacin 200mg twice per day is administrated.
    Arm Title
    Levofloxacin simulant group
    Arm Type
    Placebo Comparator
    Arm Description
    Levofloxacin simulant 200mg twice per day is administrated.
    Intervention Type
    Drug
    Intervention Name(s)
    Levofloxacin
    Other Intervention Name(s)
    Endovascular thrombectomy
    Intervention Description
    Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent.Endovascular thrombectomy is one of the treatments for acute ischemic stroke.
    Intervention Type
    Drug
    Intervention Name(s)
    Levofloxacin simulant
    Other Intervention Name(s)
    Endovascular thrombectomy
    Intervention Description
    Levofloxacin simulant is placebo.Endovascular thrombectomy is one of the treatments for acute ischemic stroke.
    Primary Outcome Measure Information:
    Title
    National Institute of Health stroke scale (NIHSS) after 3 days of Levofloxacin/simulant treatment
    Description
    National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.
    Time Frame
    immediately after 3 days of Levofloxacin/simulant treatment
    Title
    NIHSS at discharge/7 days
    Description
    National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.
    Time Frame
    discharge/7 days
    Secondary Outcome Measure Information:
    Title
    Hemorrhagic transformation and symptomatic intracranial hemorrhage
    Description
    defined by computed Tomography (CT) brain scan suggested bleeding, accompanied by an increase in National Institute of Health stroke scale (NIHSS) score of ≥4 points.
    Time Frame
    24h,3days and discharge/7 days
    Title
    Infarct volume after 3 days of Levofloxacin/simulant treatment
    Description
    assessed by magnetic resonance imaging brain scan
    Time Frame
    immediately after 3 days of Levofloxacin/simulant treatment
    Title
    Modified rankin scale (mRS) score at 30 days
    Description
    Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome.
    Time Frame
    30 days
    Title
    mRS score at 90 days
    Description
    Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome.
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-65 years. Patients with clinically confirmed acute ischemic stroke, CTA or DSA confirmed anterior circulation large vessel occlusion (ICA, M1/proximal M2 segment of MCA, tandem lesions), received emergency thrombectomy and successful recanalization (mTICI≥2b). mRS≤2 before stroke onset. Signed and dated informed consent is obtained. Levofloxacin/simulant treatment initiated with in 24h of endovascular thrombectomy. Exclusion Criteria: Patients using glucocorticoids, antiarrhythmic drugs (class I and class III antiarrhythmic drugs: quinidine, procaine amine, lidocaine, phenytoin sodium, verapamil, etc.), and quinolones within 14 days; Patients with other diseases that may aggravate adverse drug reactions, such as ventricular arrhythmias, prolonged QT interval (male: QTc>430ms, female: QTc>450ms), severe cardiac insufficiency (NYHA functional grade ≥ III), myasthenia gravis, peripheral neuropathy, seizures, tendon-related diseases, severe immune system-related diseases, hematological diseases, active hepatitis or cirrhosis, serious respiratory diseases; Abnormal liver and kidney function: glutamic oxaloacetic transaminase or glutamic pyruvic transaminase exceeds 3 times the upper limit of normal; Direct bilirubin or indirect bilirubin more than 3 times the normal upper limit; Blood creatinine exceeds 1.1 times the upper limit of normal; Creatinine clearance rate≤50ml/min; Urea nitrogen≥ 20mg/dL; Ion disorders: hyponatremia (Na<130mmol/L), hypokalemia (K<3.5mmol/L), hyperkalemia (K>5.5mmol/L); Fasting blood glucose lower than 3.9 mmol/L; Patients with symptomatic intracranial hemorrhage confirmed by clinical signs and imaging before randomization; Patients allergy to fluoroquinolones or other antibiotics; Patients with a life expectancy less than 3 months or patients unable to complete the study for other reasons; Not willing to be followed up or poor treatment compliance; Patients who are participating in other clinical studies, or have participated in other clinical studies within 3 months before enrollment, or have participated in this study; Other conditions not suitable for enrollment.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yi Yang, MD,PhD
    Phone
    13756661217
    Ext
    0086
    Email
    doctoryangyi@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhenni Guo, MD,PhD
    Phone
    18186872986
    Ext
    0086
    Email
    zhen1ni2@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yi Yang, MD,PhD
    Organizational Affiliation
    The First Hospital of Jilin University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Safety and Efficacy Study of Levofloxacin Combined With Endovascular Thrombectomy for Acute Ischemic Stroke

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