Acute Ischemic StrokeNCT05743101
Safety and Efficacy Study of Levofloxacin Combined With Endovascular Thrombectomy for Acute Ischemic Stroke
A study testing Levofloxacin and Levofloxacin simulant in people with Acute Ischemic Stroke, run by Yi Yang.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Levofloxacin and Levofloxacin simulant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Efficacy Study of Levofloxacin Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation
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.
Read the 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
- Being tested
- Levofloxacin, Levofloxacin simulant
- Keywords
- Endovascular thrombectomy, Levofloxacin
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
Also called Endovascular thrombectomy
Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent.Endovascular thrombectomy is one of the treatments for acute ischemic stroke.
Levofloxacin simulantDrug
Also called Endovascular thrombectomy
Levofloxacin simulant is placebo.Endovascular thrombectomy is one of the treatments for acute ischemic stroke.
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin group | Experimental | Levofloxacin 200mg twice per day is administrated. Receives: Drug: Levofloxacin |
| Levofloxacin simulant group | Placebo comparator | Levofloxacin simulant 200mg twice per day is administrated. Receives: Drug: Levofloxacin simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: discharge/7 days
Secondary outcomes (4)
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.
Measured: 24h,3days and discharge/7 days
Infarct volume after 3 days of Levofloxacin/simulant treatment
assessed by magnetic resonance imaging brain scan
Measured: immediately after 3 days of Levofloxacin/simulant treatment
Modified rankin scale (mRS) score at 30 days
Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome.
Measured: 30 days
mRS score at 90 days
Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 May 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
- Investigators
- Yi Yang, MD,PhD, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743101
- Sponsor's protocol ID
- LVX-EVT
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Levofloxacin Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation
- ClinicalTrials.gov ID
- NCT05743101
- Acronym / sponsor ID
- LVX-EVT
- Conditions
- Acute Ischemic Stroke
- Keywords
- Endovascular thrombectomy, Levofloxacin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin group | Experimental | Drug: LevofloxacinLevofloxacin 200mg twice per day is administrated. |
| Levofloxacin simulant group | Placebo comparator | Drug: Levofloxacin simulantLevofloxacin simulant 200mg twice per day is administrated. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevofloxacinAlso: Endovascular thrombectomyLevofloxacin is a quinolone antibiotics and newly identified neuro-protective agent.Endovascular thrombectomy is one of the treatments for acute ischemic stroke. | Drug | Levofloxacin group |
| Levofloxacin simulantAlso: Endovascular thrombectomyLevofloxacin simulant is placebo.Endovascular thrombectomy is one of the treatments for acute ischemic stroke. | Drug | Levofloxacin simulant group |
Primary outcome
National Institute of Health stroke scale (NIHSS) after 3 days of Levofloxacin/simulant treatment
Time frame: immediately 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.
NIHSS at discharge/7 days
Time frame: discharge/7 days
National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.
4 secondary outcomes
Hemorrhagic transformation and symptomatic intracranial hemorrhage
Time frame: 24h,3days and discharge/7 days
Infarct volume after 3 days of Levofloxacin/simulant treatment
Time frame: immediately after 3 days of Levofloxacin/simulant treatment
Modified rankin scale (mRS) score at 30 days
Time frame: 30 days
mRS score at 90 days
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Yang, MD,PhD principal investigator
The First Hospital of Jilin University
Questions about this trial
What is this clinical trial studying?
A study testing Levofloxacin and Levofloxacin simulant in people with Acute Ischemic Stroke, run by Yi Yang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Yang, MD,PhD (13756661217 ext. 0086, doctoryangyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institute of Health stroke scale (NIHSS) after 3 days of Levofloxacin/simulant treatment (time frame: immediately after 3 days of Levofloxacin/simulant treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.