The purpose of this study is to determine the efficacy and safety of levofloxacin combined with intravenous thrombolysis in treating acute ischemic stroke
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent. Intravenous thrombolysis is one of the treatments for acute ischemic stroke.
Levofloxacin simulant is placebo. Intravenous thrombolysis is one of the treatments for acute ischemic stroke.
First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGNational Institute of Health stroke scale (NIHSS)
NIHSS ranged from 0 to 42, a low value represents a better outcome
Time frame: in 24 hours of intravenous thrombolysis
NIHSS at discharge/7 days
NIHSS ranged from 0 to 42, a low value represents a better outcome
Time frame: discharge/7 days
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.
Time frame: 24h,3 days and discharge/7 days
Infarct volume after 3 days of Levofloxacin/simulant treatment
assessed by magnetic resonance imaging brain scan
Time frame: Immediately after 3 days of Levofloxacin/simulant treatment
Modified rankin scale (mRS) score at 30 days
mRS ranged from 0 to 6, a low value represents a better outcome
Time frame: 30 days
mRS score at 90 days
mRS ranged from 0 to 6, a low value represents a better outcome
Time frame: 90 days
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