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The purpose of this study is to determine the efficacy and safety of levofloxacin combined with intravenous thrombolysis in treating acute ischemic stroke
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levofloxacin group | Experimental | Levofloxacin 200mg twice per day is administrated. |
|
| Levofloxacin simulant group | Placebo Comparator | Levofloxacin simulant 200mg twice per day is administrated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levofloxacin | Drug | Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent. Intravenous thrombolysis is one of the treatments for acute ischemic stroke. |
| Measure | Description | Time Frame |
|---|---|---|
| National Institute of Health stroke scale (NIHSS) | NIHSS ranged from 0 to 42, a low value represents a better outcome | in 24 hours of intravenous thrombolysis |
| NIHSS at discharge/7 days | NIHSS ranged from 0 to 42, a low value represents a better outcome | discharge/7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hemorrhagic transformation and symptomatic intracranial hemorrhage | defined by computed tomography (CT) brain scan showed bleeding and a concomitant increase in National Institute of Health stroke scale (NIHSS) score of ≥4 points. | 24h,3 days and discharge/7 days |
| Infarct volume after 3 days of Levofloxacin/simulant treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Yang, MD, PhD | Contact | 13756661217 | 0086 | doctoryangyi@163.com |
| Zhen-Ni Guo, MD, PhD | Contact | 18186872986 | 0086 | zhen1ni2@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130000 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
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|
| Levofloxacin simulant | Drug | Levofloxacin simulant is placebo. Intravenous thrombolysis is one of the treatments for acute ischemic stroke. |
|
|
assessed by magnetic resonance imaging brain scan |
| Immediately after 3 days of Levofloxacin/simulant treatment |
| Modified rankin scale (mRS) score at 30 days | mRS ranged from 0 to 6, a low value represents a better outcome | 30 days |
| mRS score at 90 days | mRS ranged from 0 to 6, a low value represents a better outcome | 90 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |