Safety and Efficacy of Levofloxacin Combined With Intravenous Thrombolysis for Acute Ischemic Stroke

Not Applicable

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Levofloxacin simulant; Drug: Levofloxacin

• Registration Number: NCT05741905
• Lead Sponsor: Yi Yang

Brief Summary

The purpose of this study is to determine the efficacy and safety of levofloxacin combined with intravenous thrombolysis in treating acute ischemic stroke

Detailed Description

Acute ischemic stroke is a leading cause of disability and mortality. Intravenous thrombolysis is a major therapy for acute ischemic stroke, however, nearly half of patients failed to benefit from it. It is necessary to find new interventions combined to intravenous thrombolysis, which promote the efficacy of intravenous thrombolysis. 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 intravenous thrombolysis in treating acute ischemic stroke patients, the prospective, multicenter and randomized controlled trial was designed.

Study Timeline

• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-23
• Study Start: 2023-06-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age 18-75 years.
2. Acute ischemic stroke patients underwent intravenous thrombolysis, treated with ateplase (0.9mg/kg)
3. mRS≤1 before stroke onset, NIHSS ≥ 5 and ≤ 15，la (NIHSS) level of consciousness < 1

Exclusion Criteria

1. Endovascular treatment
2. 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;
3. 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;
4. 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;
5. Concurrent infection;
6. Fasting blood glucose lower than 3.9 mmol/L;
7. Patients with symptomatic intracranial hemorrhage confirmed by clinical signs and imaging before randomization;
8. Patients allergy to fluoroquinolones or other antibiotics;
9. Patients with a life expectancy less than 3 months or patients unable to complete the study for other reasons;
10. Not willing to be followed up or poor treatment compliance;
11. 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;
12. Other conditions not suitable for enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levofloxacin simulant group	Levofloxacin simulant	Levofloxacin simulant 200mg twice per day is administrated.
Levofloxacin group	Levofloxacin	Levofloxacin 200mg twice per day is administrated.

Primary Outcome Measures

Name	Time	Method
National Institute of Health stroke scale (NIHSS)	in 24 hours of intravenous thrombolysis	NIHSS ranged from 0 to 42, a low value represents a better outcome
NIHSS at discharge/7 days	discharge/7 days	NIHSS ranged from 0 to 42, a low value represents a better outcome

Secondary Outcome Measures

Name	Time	Method
Infarct volume after 3 days of Levofloxacin/simulant treatment	Immediately after 3 days of Levofloxacin/simulant treatment	assessed by magnetic resonance imaging brain scan
Modified rankin scale (mRS) score at 30 days	30 days	mRS ranged from 0 to 6, a low value represents a better outcome
Hemorrhagic transformation and symptomatic intracranial hemorrhage	24h,3 days and discharge/7 days	defined by computed tomography (CT) brain scan showed bleeding and a concomitant increase in National Institute of Health stroke scale (NIHSS) score of ≥4 points.
mRS score at 90 days	90 days	mRS ranged from 0 to 6, a low value represents a better outcome

Trial Locations

Locations (1)

First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China