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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.
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.
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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.Endovascular thrombectomy is one of the treatments for acute ischemic stroke. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24h,3days 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 |
| Zhenni Guo, MD,PhD | Contact | 18186872986 | 0086 | zhen1ni2@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Yang, MD,PhD | The First Hospital of Jilin University | Principal Investigator |
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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.Endovascular thrombectomy 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 | Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome. | 30 days |
| mRS score at 90 days | Modified Rankin Scale (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 |