Abstract
The aim of the Japan post-Marketing Registration Study (J-MARS) was to assess the safety and efficacy of 0.6 mg/kg alteplase in routine clinical practice for the Japanese. A total of 7492 patients from 942 centers were finally enrolled in J-MARS, an open-label, non-randomized, observational study, from October 2005 to October 2007. Primary outcome measures were symptomatic intracranial hemorrhage (sICH) (a deterioration in NIHSS score ≥4 from baseline, or the ICH leading to death) and favorable outcome (mRS 0–1) at 3 months after stroke onset. The proportion of patients with sICH in 7492 patients (safety analysis) was 3.5% within 36 hours and 4.4% at 3 months. The overall mortality rate was 13.1% and the proportion of patients with fatal sICH was 0.9%. The outcomes at 3 months were available for 4944 patients and the proportion of favorable outcome (efficacy analysis) was 33.1%, and the proportion of mRS 6 was 17%. The subgroup analysis in 3576 patients between 18 and 80 years, with a baseline NIHSS score <25 demonstrated that favorable outcome at 3 months was 39.0%. These data suggest that 0.6 mg/kg intravenous alteplase within 3 hours of stroke onset could be safe and effective in routine clinical practice.
