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

NCT ID: NCT05741905

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-12-31

Brief Summary

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

Detailed Description

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.

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. Intravenous thrombolysis 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. Intravenous thrombolysis is one of the treatments for acute ischemic stroke.

Interventions

Levofloxacin

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

Intervention Type: DRUG

Levofloxacin simulant

Levofloxacin simulant is placebo. Intravenous thrombolysis is one of the treatments for acute ischemic stroke.

Intervention Type: DRUG

Other Intervention Names

Intravenous Thrombolysis; Intravenous Thrombolysis

Eligibility Criteria

Inclusion Criteria

1. Age 18-75 years.

2. Acute ischemic stroke patients underwent intravenous thrombolysis, treated with ateplase (0.9mg/kg)

3. mRS≤1 before stroke onset, NIHSS ≥ 5 and ≤ 15，la (NIHSS) level of consciousness < 1

Exclusion Criteria

1. Endovascular treatment

2. 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;

3. 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;

4. 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;

5. Concurrent infection;

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

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

8. Patients allergy to fluoroquinolones or other antibiotics;

9. Patients with a life expectancy less than 3 months or patients unable to complete the study for other reasons;

10. Not willing to be followed up or poor treatment compliance;

11. 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;

12. 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

Locations

First Hospital of Jilin University

Changchun, Jilin, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yi Yang, MD, PhD

Role: CONTACT

doctoryangyi@163.com

13756661217 ext. 0086

Zhen-Ni Guo, MD, PhD

Role: CONTACT

zhen1ni2@163.com

18186872986 ext. 0086

Facility Contacts

Yi Yang, MD, PhD

Role: primary

doctoryangyi@163.com

86-18186870008

Other Identifiers

LVX-IVT

Identifier Type: -

Identifier Source: org_study_id