Thrombolysis With 0.6 mg/kg Intravenous Alteplase for Acute Ischemic Stroke in Routine Clinical Practice The Japan post-Marketing Alteplase Registration Study (J-MARS)

Background and Purpose—In Japan, alteplase at 0.6 mg/kg was approved in October 2005 for use within 3 hours of stroke onset by the Ministry of Health, Labor and Welfare (MHLW). The aim of the Japan post-Marketing Alteplase Registration Study (J-MARS), which was requested by MHLW at the time of approval, was to assess the safety and efficacy of 0.6 mg/kg alteplase in routine clinical practice for the Japanese. Methods—A total of 7492 patients from 942 centers were enrolled in the J-MARS, an open-label, nonrandomized, observational study, from October 2005 to October 2007. Primary outcome measures were symptomatic intracranial hemorrhage (a deterioration in NIHSS score ≥4 from baseline) and favorable outcome (modified Rankin Scale score, 0–1) at 3 months after stroke onset. Results—The proportion of patients with symptomatic intracranial hemorrhage in 7492 patients (safety analysis) was 3.5% (95% confidence interval [CI], 3.1%–3.9%) within 36 hours and 4.4% (95% CI, 3.9%–4.9%) at 3 months. The overall morta...