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

NCT05743101 | Not Yet Recruiting

• 1 other identifier: LVX-EVT
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Ischemic Stroke

Keywords

Endovascular thrombectomy, Levofloxacin

Outcome Measures

Primary Outcomes (2)

• National Institute of Health stroke scale (NIHSS) 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.

  immediately after 3 days of Levofloxacin/simulant treatment

• NIHSS at discharge/7 days

  National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.

  discharge/7 days

Secondary Outcomes (4)

• Hemorrhagic transformation and symptomatic intracranial hemorrhage

  24h,3days and discharge/7 days

• Infarct volume after 3 days of Levofloxacin/simulant treatment

  immediately after 3 days of Levofloxacin/simulant treatment

• Modified rankin scale (mRS) score at 30 days

  30 days

• mRS score at 90 days

  90 days

Study Arms (2)

Levofloxacin group

EXPERIMENTAL

Levofloxacin 200mg twice per day is administrated.

Drug: Levofloxacin

Levofloxacin simulant group

PLACEBO COMPARATOR

Levofloxacin simulant 200mg twice per day is administrated.

Drug: Levofloxacin simulant

Interventions

Levofloxacin DRUG

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

Also known as: Endovascular thrombectomy

Levofloxacin group

Levofloxacin simulant DRUG

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

Also known as: Endovascular thrombectomy

Levofloxacin simulant group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years.
• 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.
• mRS≤1 before stroke onset.
• Signed and dated informed consent is obtained.

You may not qualify if:

• Patients with contraindications to emergency thrombectomy;
• The head CT showed large facial cerebral infarction;
• 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;
• Fasting blood glucose lower than 3.9 mmol/L;
• 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.

Sponsors & Collaborators

• Yi Yang: lead

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yi Yang, MD,PhD

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Yang, MD,PhD

CONTACT

13756661217; doctoryangyi@163.com

Zhenni Guo, MD,PhD

CONTACT

18186872986; zhen1ni2@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Dean of First Hospital of Jilin University

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 24, 2023
• Study Start: May 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 2, 2024

Record last verified: 2024-02