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To explore the safety and efficacy of edaravone dexborneol for patients of acute ischemic stroke received endovascular therapy in extended time windows.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Edaravone Dexborneol | Experimental |
| |
| conventional therapy | No Intervention | conventional therapy of acute ischemic stroke after Endovascular Therapy based on Chinese guidelines for endovascular therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edaravone Dexborneol | Drug | Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 7-14days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with modified Rankin Score 0 to 3 on day 90 | 90 days | |
| Proportion of symptomatic intracranial hemorrhage (sICH) | 48 hours | |
| mTICI grade (<2 b、≥2 b) stratified for primary outcome analysis | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in National Institute of Health stroke scale (NIHSS) on day 2,7,14 | 14 days | |
| Distribution of modified Rankin Score after the treatment | 90 days | |
| Change in infarct volume |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianfeng Han, MD | Contact | +8618991232708 | rabbit1110@163.com | |
| Ying Tan, MD | Contact | +8613581693768 | 13581693768@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xian Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | 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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| 7 days |
| The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90 | 90 days |
| Activity of Daily Living Scale(ADL) score on day 14, 30, 90 | 90 days |
| Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90 | 90 days |
| Serum inflammatory factors changes on day 1 and day 7 | 7 days |
| Proportion of PH1 and PH2 within 48 hours after the treatment | 48 hours |
| Midline shift on the CT scan | 7 days |
| Proportion of death due to any cause | 90 days |
| Proportion of Serious adverse events(SAE) | 90 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |