Acute ischemic stroke
Conditions
Interventions
Edaravone is administered before or at the same time with t-PA infusion
Edaravone is administered after the assessment of the presence of recanalization.
Sponsors
Neurology, Nippon Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients who can be treated with edaravone within 3 h of onset (When the Japanese guideline of the t-PA infusion permits the t-PA infusion in patients within within 4.5h of onset, this criteria will be automatically modefied to include patietns within 4.5 of onset.) (2)Patients with horizontal or silvian portion of middle cerebral artery (MCA, M1 and M2) occlusion. (3)All patients or their family provided a written Institutional Review Board-approved informed consent. (4)Other inclusion criteria are similar to the Japanese guidelin of the t-PA infusion.
Exclusion criteria
Exclusion criteria: (1)Patients with large infarcts on initial diffusion-weighted imaging (DWI) were excluded, using a DWI Alberta Stroke Programme Early computed tomography score (DWI-ASPECTS) of 4 and under to define large infarcts. (2)Patients with internal carotid artery occlusion. (3)Patients diagniosed as having bilateral symptomatic MCA occlusion. (4)Patients with serum concentration of creatinine over 1.5mg/dl (5)Patients who cannot be exmined using Magnetic resonance imaging. (6)Patients who is and is suspected to be pregnant (7)Patients with contraindication to the use of edaravone and to the Japanese guidelin of the t-PA infusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recanalization within one hour after t-PA infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Recanalization over 50% within one hour after t-PA infusion (2)Complete recanalization within one hour after t-PA infusion (3)Clinical outcome at 3 months after onset. We defined favorable outcomes as an modified Rankin scale (mRS) score of 0-2. (4)Clinical improvement and deterioration after 1 h, 24 h, and 5-7 days. Dramatic recovery was defined as a 10-point and over reduction in total National Institutes of Health Stroke Scale (NIHSS) score or a total NIHSS score of 0 or 1. Good recovery was a 4-point and over reduction in total NIHSS score, excluding dramatic recovery. No change was from a 3-point increase to a 3-point reduction in total NIHSS score. Worsening was a 4-point and over increase in total NIHSS sore. (5)Symptomatic cerebral hemorrhage at 1 h, 24 h, and 5-7 days, defined as an increase in NIHSS score of 4 and over | — |
Countries
Japan
Contacts
Public ContactJunya Aoki
Nippon Medical School Neurology
Outcome results
None listed