An observational study in Stroke, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-23.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 200 is above the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Drug: Edaravone Dexborneol
Patients who do not recieve edaravone dexborneol will be classified into this group.
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)
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
Time frame: 90 days
Growth in infarct volume (mL)
24 hour infarct volume (mL) - 7 day infarct volume (mL)
Time frame: from 24 hours to 7 days
Salvaged ischemic tissue index (%)
100%\*(baseline hypoperfusion (mL) - 7 day infarction lesion (mL))/ baseline hypoperfusion (mL)
Time frame: from baseline to 7 days
Frequency of parenchymal hemorrhage (PH) (%)
The presence of PH is defined according the standard from ECASS-2 study thrombectomy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 90 days
Recovery assessed by modefied Rankin Scale (mRS) score
mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome
Time frame: 90 days
Plan to share: Undecided
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This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University