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To explore the safety and efficacy of edaravone dexborneol for the treatment of acute ischemic stroke patients who received endovascular thrombectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.9% NaCl | Placebo Comparator | Intravenous injections of 0.9% NaCl BID for 12 ±2days. |
|
| Edaravone Dexborneol | Experimental | Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 12 ±2days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| edaravone dexborneol | Drug | Intravenous injections of edaravone dexborneol (37.5mg, dissolved in 100ml saline) twice a day for 12 ±2 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with modified Rankin Score 0 to 2 | Proportion of patients with modified Rankin Score 0 to 2 | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with modified Rankin Score 0 to 1 | Proportion of patients with modified Rankin Score 0 to 1 | Day 90 |
| Distribution of modified Rankin Score | Distribution of modified Rankin Score after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of symptomatic intracranial hemorrhage (sICH) | sICH was defined as 4 or more increase in NIHSS caused by hemorrhage | 48 hours |
| Proportion of intraparenchymal hemorrhage (PH1 and PH2) | Proportion of PH1 and PH2 within 48 hours after the treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Northern Theater Command | Shenyang | 110840 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40064868 | Derived | Chen HS, Zhao ZA, Shen XY, Qiu SQ, Cui Y, Qiu J, Li W, Zhang H, Chen WH, Wang LH, Zhang DH, Chen Y, Ma YT, Gao ZE, Wang SC, Li D, Liu H, Nguyen TN. Edaravone dexborneol for ischemic stroke with sufficient recanalization after thrombectomy: a randomized phase II trial. Nat Commun. 2025 Mar 10;16(1):2393. doi: 10.1038/s41467-025-57774-x. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Day 90 |
| Changes in National Institute of Health stroke scale (NIHSS) | the minimum and maximum values of NIHSS are 42 and 0, respectively; higher NIHSS mean a worse outcome | 24 hours, 48 hours, and 2 weeks |
| Change in infarct volume | infarct volume is determinted by CT or DWI | 1 week |
| 48 hours |
| Proportion of death | death due to any cause | Day 90 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |