Edaravone Dexborneol Combining With Mechanical Thrombectomy in the Treatment of Acute Ischemic Stroke
- Registration Number
- NCT05121883
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- Patients without recanalization (TICI 0,1, 2a)
- Pre-existing neurological disability (a score greater than 2 on the mRS)
- Contraindication of edaravone dexborneol
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Edaravone dexborneol group Edaravone Dexborneol 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
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
Frequency of parenchymal hemorrhage (PH) (%) 24 hours The presence of PH is defined according the standard from ECASS-2 study thrombectomy
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
Recovery assessed by modefied Rankin Scale (mRS) score 90 days mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome
Trial Locations
- Locations (1)
The second affiliated hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China