Abstract
Edaravone was originally developed as a potent free radical scavenger and has been prevalent for the treatment of cerebral infarction in Japan since 2001. PROTECT4.5 (Post-marketing Registry On Treatment with Edaravone in acute Cerebral infarction by the Time window of 4.5 hours) is a prospective observational cohort study to investigate the efficacy and safety of edaravone or concomitant treatment with rt-PA in over 10,000 patients. 7,170 patients from 889 institutions were enrolled and had received edaravone treatment by December 2011. Case report forms (CRF) within 3 weeks after the onset of ischemic stroke were obtained in 4,270 patients. Of these, 2,066 patients were treated with rt-PA and 2,204 patients without. Symptomatic intracranial hemorrhage (sICH) was observed in 1.6% of the concomitantly treated rt-PA patients.
