About this trial
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
This trial does not accept healthy volunteersQualifiers
Age 18-75 years.
Acute ischemic stroke patients underwent intravenous thrombolysis, treated with ateplase (0.9mg/kg)
mRS≤1 before stroke onset, NIHSS ≥ 5 and ≤ 15,la (NIHSS) level of consciousness < 1
Disqualifiers
Endovascular treatment
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;
Trial design
Parallel
Treatments tested in this trial
Levofloxacin
DrugLevofloxacin is a quinolone antibiotics and newly identified neuro-protective agent. Intravenous thrombolysis is one of the treatments for acute ischemic stroke.
Levofloxacin simulant
DrugLevofloxacin simulant is placebo. Intravenous thrombolysis is one of the treatments for acute ischemic stroke.
Treatment groups
Trial outcomes
Primary outcomes
National Institute of Health stroke scale (NIHSS)
NIHSS ranged from 0 to 42, a low value represents a better outcome
NIHSS at discharge/7 days
NIHSS ranged from 0 to 42, a low value represents a better outcome
Secondary outcomes
Hemorrhagic transformation and symptomatic intracranial hemorrhage
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.
Infarct volume after 3 days of Levofloxacin/simulant treatment
assessed by magnetic resonance imaging brain scan
Modified rankin scale (mRS) score at 30 days
mRS ranged from 0 to 6, a low value represents a better outcome
mRS score at 90 days
mRS ranged from 0 to 6, a low value represents a better outcome
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yi Yang
Lead sponsor
The First Hospital of Jilin University
Sponsor institution