Stroke
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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)
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients presenting with anterior circulation acute ischemic stroke * Patients aged between 18-80 years. * CTA or DSA verified arterial occlusion of ICA, M1 or M2. * NIHSS on admission 4 - 26 * Baseline CTP verified infarct core \< 70 ml, penumbra \> 10 ml, hypoperfusion/core \> 1.8 * Undergoing mechanical thrombectomy within 24 hours of stroke onset. For wake-up stroke, the onset time is determined as the midpoint of last-seen-well and discovered time
Exclusion criteria
* Patients without recanalization (TICI 0,1, 2a) * Pre-existing neurological disability (a score greater than 2 on the mRS) * Contraindication of edaravone dexborneol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of functional independence at 90 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Growth in infarct volume (mL) | from 24 hours to 7 days | 24 hour infarct volume (mL) - 7 day infarct volume (mL) |
| Salvaged ischemic tissue index (%) | from baseline to 7 days | 100%\*(baseline hypoperfusion (mL) - 7 day infarction lesion (mL))/ baseline hypoperfusion (mL) |
| Frequency of parenchymal hemorrhage (PH) (%) | 24 hours | The presence of PH is defined according the standard from ECASS-2 study thrombectomy |
| Recovery assessed by modefied Rankin Scale (mRS) score | 90 days | mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome |
| Change on the National Institute of Health stroke scale (NIHSS) score from 1 day to 7 day | from 1 day to 7 days | NIHSS: minimum value = 0, maximum value = 42, and higher scores mean severer symptoms |
| Excellent recovery assessed by the ratio of modefied Rankin Scale (mRS) score of 0-1 | 90 days | mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome |
| Change on the National Institute of Health stroke scale (NIHSS) score from baseline to 1 day | from baseline to 1 day | NIHSS: minimum value = 0, maximum value = 42, and higher scores mean severer symptoms |
Countries
China
Contacts
Primary ContactMin Lou, PhD, MD
Outcome results
None listed