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Clinical Trials in China / NCT05741905
Recruiting Not applicable

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

NCT05741905 · tracked via the Priya Life Science China tracker
Sponsor
Yi Yang
Phase
Not applicable
Started
2023-06-01
Last updated
2024-10-02

Condition(s) studied

Acute Ischemic Stroke

Investigational drug(s) / intervention(s)

LevofloxacinLevofloxacin simulant

Levofloxacin: Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent. Intravenous thrombolysis is one of the treatments for acute ischemic stroke.

Levofloxacin simulant: Levofloxacin simulant is placebo. Intravenous thrombolysis is one of the treatments for acute ischemic stroke.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
First Hospital of Jilin University Changchun Jilin Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05741905 on ClinicalTrials.gov ↗ ← All trials in China