Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke "EAST"

Completed

Phase 4 Results

Results

The FAS consisted of 808 patients, 406 being assigned to the combination therapy and 402 to the monotherapy group. Background characteristics were comparable between the groups, including the baseline NIH Stroke Scale score. Patients with mRS 0 to 1 (47% vs. 42%, p=0.126) and those with Barthel Index 95 to 100 (60% vs. 53%, p=0.032) were more frequent at 3 weeks post-stroke in the combination than in the monotherapy group. However, both the groups had frequently the primary end point of excellent outcome (mRS 0 to 1) at 90 days, being not different between the groups (51% vs. 50%). The 90-day mortality (1.2% vs. 1.5%), and the rates of 3 weeks SICH (0.5% vs. 0.5%) and other secondary endpoints were also similar. We could not demonstrate favorable effects of edaravone when added to the baseline treatment with argatroban, which was often associated with excellent outcome at 90 days, in patients with acute ATBI within 24 hours after the onset of symptoms.