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Edaravone dexborneol, comprised of 2 active ingredients, edaravone and (+)-borneol, has been developed as a novel neuroprotective agent with synergistic effects of antioxidant and anti-inflammatory in animal models. The TASTE trial (Treatment of Acute Ischemic Stroke with Edaravone Dexborneol) administered edaravone dexborneol or edaravone alone to stroke patients within 48 hours after stroke onset, finding that 90-d functional outcome was better in edaravone dexborneol group. However, the TASTE trial excluded patients undergoing reperfusion therapy (i.e., intravenous thrombolysis and mechanical thrombectomy). Therefore, the investigators aim to evaluate the efficacy of edaravone dexborneol in addition to mechanical thrombectomy in the treatment of acute ischemic stoke.
This is a prospective, non-randomized clinical trial in multiple stroke centres of China. The total sample size will be 200. Patients with anterior-circulation large artery occlusion obtaining successful recanalization after mechanical thrombectomy (MT) will be assigned into edaravone dexborneol or standard medication treatment group based on whether or not receiving edaravone dexborneol. Only patients with edaravone dexborneol initiating within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days could be enrolled as edaravone dexborneol group. Patients in standard medication treatment group must not receive edaravone dexborneol. Other neuroprotective agents are not limited to use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Edaravone dexborneol group | Patients with edaravone dexborneol initiating within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days will be classified into this group. |
| |
| Standard medication group | Patients who do not recieve edaravone dexborneol will be classified into this group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edaravone Dexborneol | Drug | Edaravone dexborneol (Jiangsu Simcere Pharmaceutical, Co, Ltd) will be initiated within 48 hours of stoke onset at 37.5 mg/dose, once every 12 hours, and continuing for more than 7 days (maximum: 14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of functional independence at 90 days | Functional independence will be assessed by ratio of modefied Rankin Scale (mRS) score of 0-2 mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Growth in infarct volume (mL) | 24 hour infarct volume (mL) - 7 day infarct volume (mL) | from 24 hours to 7 days |
| Salvaged ischemic tissue index (%) | 100%*(baseline hypoperfusion (mL) - 7 day infarction lesion (mL))/ baseline hypoperfusion (mL) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged between 18-80 years with anterior circulation stroke obtaining successful recanalization after mechanical thrombectomy within 24 hours of onset will be included. CTP prior to mechanical thrombectomy must be performed to verify infarct core < 70 ml, penumbra > 10 ml, hypoperfusion/core > 1.8. Patients without recanalization after mechanical thrombectomy or have a pre-mRS greater than 2 will be excluded.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Lou, PhD, MD | Contact | 13958007213 | loumingxc@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Min Lou, PhD, MD | the 2nd affiliated hospital of Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second affiliated hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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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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| from baseline to 7 days |
| Frequency of parenchymal hemorrhage (PH) (%) | The presence of PH is defined according the standard from ECASS-2 study thrombectomy | 24 hours |
| Change on the National Institute of Health stroke scale (NIHSS) score from baseline to 1 day | NIHSS: minimum value = 0, maximum value = 42, and higher scores mean severer symptoms | from baseline to 1 day |
| Change on the National Institute of Health stroke scale (NIHSS) score from 1 day to 7 day | NIHSS: minimum value = 0, maximum value = 42, and higher scores mean severer symptoms | from 1 day to 7 days |
| Excellent recovery assessed by the ratio of modefied Rankin Scale (mRS) score of 0-1 | mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome | 90 days |
| Recovery assessed by modefied Rankin Scale (mRS) score | mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome | 90 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |