Clinical trial NCT05741905: Safety and Efficacy of Levofloxacin Combined With Intravenous Thrombolysis for Acute Ischemic Stroke
Official title: Safety and Efficacy of Levofloxacin Combined With Intravenous Thrombolysis for Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Acute ischemic stroke
Intravenous thrombolysis
Levofloxacin
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: National Institute of Health stroke scale (NIHSS)
timeFrame: in 24 hours of intravenous thrombolysis
measure: NIHSS at discharge/7 days
timeFrame: discharge/7 days
Secondary outcomes:
measure: Hemorrhagic transformation and symptomatic intracranial hemorrhage
timeFrame: 24h,3 days and discharge/7 days
measure: Infarct volume after 3 days of Levofloxacin/simulant treatment
timeFrame: Immediately after 3 days of Levofloxacin/simulant treatment
measure: Modified rankin scale (mRS) score at 30 days
timeFrame: 30 days
measure: mRS score at 90 days
timeFrame: 90 days
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
References: