Safety and Efficacy Study of Levofloxacin Combined With Endovascular Thrombectomy for Acute Ischemic Stroke

• Status: Not yet recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yi Yang
• Treatments: Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

1. Age 18-65 years.

2. Patients with clinically confirmed acute ischemic stroke, CTA or DSA confirmed anterior circulation large vessel occlusion (ICA, M1/proximal M2 segment of MCA, tandem lesions), received emergency thrombectomy and successful recanalization (mTICI≥2b).

3. mRS≤2 before stroke onset.

4. Signed and dated informed consent is obtained.

5. Levofloxacin/simulant treatment initiated with in 24h of endovascular thrombectomy.

Exclusion Criteria:

1. 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;

2. 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;

3. 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;

4. Ion disorders: hyponatremia (Na<130mmol/L), hypokalemia (K<3.5mmol/L), hyperkalemia (K>5.5mmol/L);

5. Fasting blood glucose lower than 3.9 mmol/L;

6. Patients with symptomatic intracranial hemorrhage confirmed by clinical signs and imaging before randomization;

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.