Acute Ischemic Stroke
Conditions
Keywords
Endovascular thrombectomy, Levofloxacin
Brief summary
The purpose of this study is to determine the efficacy and safety of levofloxacin combined with endovascular thrombectomy in treating acute ischemic stroke due to large vessel occlusion of anterior circulation.
Detailed description
Acute ischemic stroke is a leading cause of disability and mortality. Emergency thrombectomy is the highest recommended treatment for patients with large vessel occlusion. However, there are still some patients with severe disability or mortality within 90 days after surgery. It is necessary to find new interventions combined to endovascular thrombectomy, which promote the efficacy of endovascular thrombectomy. 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 endovascular thrombectomy in treating acute ischemic stroke patients due to large vessel occlusion of anterior circulation, the prospective, multicenter and randomized controlled trial was designed.
Interventions
DRUGLevofloxacin
Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent.Endovascular thrombectomy is one of the treatments for acute ischemic stroke.
Levofloxacin simulant is placebo.Endovascular thrombectomy is one of the treatments for acute ischemic stroke.
Sponsors
Yi Yang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75 years. 2. Patients with clinically confirmed acute ischemic stroke within 24 hours after onset, CTA or DSA confirmed anterior circulation large vessel occlusion (ICA, M1/proximal M2 segment of MCA, tandem lesions), met the current guidelines for emergency endovascular interventional therapy, and underwent emergency thrombectomy. 3. mRS≤1 before stroke onset. 4. Signed and dated informed consent is obtained.
Exclusion criteria
1. Patients with contraindications to emergency thrombectomy; 2. The head CT showed large facial cerebral infarction; 3. 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; 4. 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; 5. 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; 6. Fasting blood glucose lower than 3.9 mmol/L; 7. Patients allergy to fluoroquinolones or other antibiotics; 8. Patients with a life expectancy less than 3 months or patients unable to complete the study for other reasons; 9. Not willing to be followed up or poor treatment compliance; 10. 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; 11. Other conditions not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| National Institute of Health stroke scale (NIHSS) after 3 days of Levofloxacin/simulant treatment | immediately after 3 days of Levofloxacin/simulant treatment | National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome. |
| NIHSS at discharge/7 days | discharge/7 days | National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemorrhagic transformation and symptomatic intracranial hemorrhage | 24h,3days and discharge/7 days | defined by computed Tomography (CT) brain scan suggested bleeding, accompanied by an increase in National Institute of Health stroke scale (NIHSS) score of ≥4 points. |
| Infarct volume after 3 days of Levofloxacin/simulant treatment | immediately after 3 days of Levofloxacin/simulant treatment | assessed by magnetic resonance imaging brain scan |
| Modified rankin scale (mRS) score at 30 days | 30 days | Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome. |
| mRS score at 90 days | 90 days | Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome. |
Contacts
Primary ContactYi Yang, MD,PhD
Backup ContactZhenni Guo, MD,PhD
Outcome results
None listed