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

NCT ID: NCT05743101

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-07-01

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Levofloxacin group

Levofloxacin 200mg twice per day is administrated.

Group Type: EXPERIMENTAL

Levofloxacin

Intervention Type: DRUG

Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent.Endovascular thrombectomy is one of the treatments for acute ischemic stroke.

Levofloxacin simulant group

Levofloxacin simulant 200mg twice per day is administrated.

Group Type: PLACEBO_COMPARATOR

Levofloxacin simulant

Intervention Type: DRUG

Levofloxacin simulant is placebo.Endovascular thrombectomy is one of the treatments for acute ischemic stroke.

Interventions

Levofloxacin

Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent.Endovascular thrombectomy is one of the treatments for acute ischemic stroke.

Intervention Type: DRUG

Levofloxacin simulant

Levofloxacin simulant is placebo.Endovascular thrombectomy is one of the treatments for acute ischemic stroke.

Intervention Type: DRUG

Other Intervention Names

Endovascular thrombectomy; Endovascular thrombectomy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yi Yang

OTHER

Sponsor Role: lead

Responsible Party

Yi Yang

Associated Dean of First Hospital of Jilin University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yi Yang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Central Contacts

Yi Yang, MD,PhD

Role: CONTACT

doctoryangyi@163.com

13756661217 ext. 0086

Zhenni Guo, MD,PhD

Role: CONTACT

zhen1ni2@163.com

18186872986 ext. 0086

Other Identifiers

LVX-EVT

Identifier Type: -

Identifier Source: org_study_id