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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy Study of Levofloxacin Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: Levofloxacin
* Drug: Levofloxacin simulant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levofloxacin group<br>Levofloxacin 200mg twice per day is administrated. | Drug: Levofloxacin<br>* Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent.Endovascular thrombectomy is one of the treatments for acute ischemic stroke.<br>* Other names: Endovascular thrombectomy;|
| Placebo Comparator: Levofloxacin simulant group<br>Levofloxacin simulant 200mg twice per day is administrated. | Drug: Levofloxacin simulant<br>* Levofloxacin simulant is placebo.Endovascular thrombectomy is one of the treatments for acute ischemic stroke.<br>* Other names: Endovascular thrombectomy;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24h,3days and discharge/7 days | 
| Infarct volume after 3 days of Levofloxacin/simulant treatment | assessed by magnetic resonance imaging brain scan | immediately after 3 days of Levofloxacin/simulant treatment | 
| Modified rankin scale (mRS) score at 30 days | Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome. | 30 days | 
| mRS score at 90 days | Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endovascular thrombectomy, Levofloxacin