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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYi Yang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Levofloxacin

    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

    Drug

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Levofloxacin groupExperimental treatment 1 intervention
Group B: Levofloxacin simulant groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
immediately after 3 days of Levofloxacin/simulant treatment
2

NIHSS at discharge/7 days

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

Time frame
discharge/7 days

Secondary outcomes

1

Hemorrhagic transformation and symptomatic intracranial hemorrhage

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.

Time frame
24h,3days and discharge/7 days
2

Infarct volume after 3 days of Levofloxacin/simulant treatment

assessed by magnetic resonance imaging brain scan

Time frame
immediately after 3 days of Levofloxacin/simulant treatment
3

Modified rankin scale (mRS) score at 30 days

Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome.

Time frame
30 days
4

mRS score at 90 days

Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome.

Time frame
90 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yi Yang

Lead sponsor

The First Hospital of Jilin University

Sponsor institution

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