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Not Yet Recruiting NCT05741905

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

Conditions: Acute Ischemic Stroke

Sex: All
Ages: 18 Years – 65 Years
Phase: NA
Enrollment: 100
Sponsor: Yi Yang

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 Criteria

Inclusion Criteria:Age 18-65 years.Acute ischemic stroke patients underwent intravenous thrombolysis, treated with ateplase (0.9mg/kg)mRS≤2 before stroke onset, NIHSS≥5 after intravenous thrombolysisSigned and dated informed consent is obtainedLevofloxacin/simulant treatment initiated within 24h of intravenous thrombolysisExclusion 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05741905). StuddyBuddy aggregates publicly available trial information.