Safety and Efficacy of Levofloxacin Combined With Intravenous Thrombolysis for Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- National Institute of Health stroke scale (NIHSS)
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of levofloxacin combined with intravenous thrombolysis in treating acute ischemic stroke
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Levofloxacin group
Levofloxacin 200mg twice per day is administrated.
干预措施: Levofloxacin (Drug)
Levofloxacin simulant group
Levofloxacin simulant 200mg twice per day is administrated.
干预措施: Levofloxacin simulant (Drug)
结局指标
主要结局
National Institute of Health stroke scale (NIHSS)
时间窗: in 24 hours of intravenous thrombolysis
NIHSS ranged from 0 to 42, a low value represents a better outcome
NIHSS at discharge/7 days
时间窗: discharge/7 days
NIHSS ranged from 0 to 42, a low value represents a better outcome
次要结局
- Infarct volume after 3 days of Levofloxacin/simulant treatment(Immediately after 3 days of Levofloxacin/simulant treatment)
- Modified rankin scale (mRS) score at 30 days(30 days)
- Hemorrhagic transformation and symptomatic intracranial hemorrhage(24h,3 days and discharge/7 days)
- mRS score at 90 days(90 days)
研究者
Yi Yang
Associated Dean of First Hospital of Jilin University
The First Hospital of Jilin University