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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: Levofloxacin; Drug: Levofloxacin simulant

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Yang, MD,PhD; Phone Number: 0086 13756661217; Email: doctoryangyi@163.com
• Study Contact Backup: Name: Zhenni Guo, MD,PhD; Phone Number: 0086 18186872986; Email: zhen1ni2@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-75 years.
2. Patients with clinically confirmed acute ischemic stroke within 24 hours after onset, CTA or DSA confirmed anterior circulation large vessel occlusion (ICA, M1/proximal M2 segment of MCA, tandem lesions), met the current guidelines for emergency endovascular interventional therapy, and underwent emergency thrombectomy.
3. mRS≤1 before stroke onset.
4. Signed and dated informed consent is obtained.

Exclusion Criteria:

1. Patients with contraindications to emergency thrombectomy;
2. The head CT showed large facial cerebral infarction;
3. 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;
4. 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;
5. 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;
6. Fasting blood glucose lower than 3.9 mmol/L;
7. Patients allergy to fluoroquinolones or other antibiotics;
8. Patients with a life expectancy less than 3 months or patients unable to complete the study for other reasons;
9. Not willing to be followed up or poor treatment compliance;
10. 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;
11. Other conditions not suitable for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yi Yang
• Investigators: Principal Investigator: Yi Yang, MD,PhD, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Endovascular thrombectomy, Levofloxacin
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Levofloxacin; Ofloxacin
• Other Study ID Numbers: LVX-EVT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No