tissue type plasminogen activator(t-PA) and Edaravon combination therapy study

Phase 3

Completed

Conditions: Acute ischemic stroke

Registration Number: JPRN-UMIN000006330

Lead Sponsor: eurology, Nippon Medical School

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete: follow-up complete

Sex: All

Target Recruitment: 200

Inclusion Criteria

Not provided

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recanalization within one hour after t-PA infusion

Secondary Outcome Measures

Name	Time	Method
(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