Factors Predicting Outcome in Stroke Patients Treated With 0.6 mg/kg Alteplase: Evidence From the Japan Alteplase Clinical Trial (J-ACT)

Abstract

The aim of the present study was to identify factors associated with functional outcome, mortality, and symptomatic intracranial hemorrhage (sICH) in patients from the Japan Alteplase Clinical Trial (J-ACT) data set with ischemic stroke treated with intravenous (IV) 0.6 mg/kg alteplase within 3 hours after onset. The patient sample comprised 103 patients from the J-ACT, a multicenter, single-dose, open-label cohort study conducted to verify the efficacy and safety of IV 0.6 mg/kg alteplase in treating acute hemispheric stroke. The effects of 21 patient baseline characteristics on a favorable outcome (as evaluated by modified Rankin scale [mRS] score of 0-1 after 3 months), death within 3 months, and incidence of sICH within 36 hours after the start of treatment were examined by univariate analysis and stepwise logistic regression analysis. The baseline characteristics associated with a favorable outcome in univariate analysis included age and National Institutes of Health Stroke Scale (NIHSS) score. The factors associated with death included age and the NIHSS score. No factors were significantly associated with sICH. In stepwise logistic regression analysis, age and NIHSS score significantly predicted both favorable outcome and death. No factors significantly predicted sICH. Age and baseline NIHSS score were independent predictors for both favorable outcome and death. Although these factors are consistent with those found to be predictors in studies on IV 0.9 mg/kg alteplase, there were no factors predicting outcomes specific for IV 0.6 mg/kg alteplase.