Safety and Efficacy of Levofloxacin Combined With Intravenous Thrombolysis for Acute Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Levofloxacin, Levofloxacin simulant.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Levofloxacin
Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent. Intravenous thrombolysis is one of the treatments for acute ischemic stroke. - Drug Levofloxacin simulant
Levofloxacin simulant is placebo. Intravenous thrombolysis is one of the treatments for acute ischemic stroke.
Primary outcome measures
- National Institute of Health stroke scale (NIHSS) [Time frame: in 24 hours of intravenous thrombolysis]
- NIHSS at discharge/7 days [Time frame: discharge/7 days]
Secondary outcome measures (4)
- Hemorrhagic transformation and symptomatic intracranial hemorrhage [Time frame: 24h,3 days and discharge/7 days]
- Infarct volume after 3 days of Levofloxacin/simulant treatment [Time frame: Immediately after 3 days of Levofloxacin/simulant treatment]
- Modified rankin scale (mRS) score at 30 days [Time frame: 30 days]
- mRS score at 90 days [Time frame: 90 days]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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;
- Concurrent infection;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- First Hospital of Jilin University — Changchun
Identifiers
NCT: NCT05741905 · LVX-IVT