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

Обзор

The purpose of this study is to determine the efficacy and safety of levofloxacin combined with intravenous thrombolysis in treating acute ischemic stroke

Подробное описание

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.

Вмешательства

• Препарат Levofloxacin
  Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent. Intravenous thrombolysis is one of the treatments for acute ischemic stroke.
• Препарат Levofloxacin simulant
  Levofloxacin simulant is placebo. Intravenous thrombolysis is one of the treatments for acute ischemic stroke.

Первичные конечные точки

• National Institute of Health stroke scale (NIHSS) [Срок оценки: in 24 hours of intravenous thrombolysis]
• NIHSS at discharge/7 days [Срок оценки: discharge/7 days]

Вторичные конечные точки (4)

• Hemorrhagic transformation and symptomatic intracranial hemorrhage [Срок оценки: 24h,3 days and discharge/7 days]
• Infarct volume after 3 days of Levofloxacin/simulant treatment [Срок оценки: Immediately after 3 days of Levofloxacin/simulant treatment]
• Modified rankin scale (mRS) score at 30 days [Срок оценки: 30 days]
• mRS score at 90 days [Срок оценки: 90 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• First Hospital of Jilin University — Changchun

Идентификаторы

NCT: NCT05741905 · LVX-IVT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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