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BACKGROUND AND PURPOSE-Based on previous studies comparing different recombinant tissue plasminogen activator(rt-PA)doses,we performed a clinical trial with 0.6 mg/kg,which is lower than the internationally approved dosage of 0.9 mg/kg,aiming to assess the efficacy and safety of alteplase in acute ischemic stroke for the Japanese.METHODS-Our prospective,multicenter,single-arm,open-label trial was designed with a target sample size of 100 patients.The primary end points were the proportion of patients with a modified Rankin Scale(mRS)score of 0 to 1 at 3 months and the incidence of symptomatic intracranial hemorrhage(sICH)within 36 hours.Thresholds for these end points were determined by calculating 90%CIs of weighted averages derived from published reports.The protocol was defined according to the National Institute of Neurological Disorders and Stroke(NINDS)rt-PA stroke study with slight modifications.RESULTS-Among the 103 patients enrolled,38 had an mRS of 0 to 1 at 3 months;this proportion(36.9%)exceeded the predetermined threshold of 33.9%.sICH within 36 hours occurred in 6 patients;this incidence(5.8%)was lower than the threshold of 9.6%.CONCLUSIONS-In patients receiving 0.6 mg/kg alteplase,the outcome and the incidence of sICH were comparable to published data for 0.9 mg/kg.These findings indicate that alteplase,when administered at 0.6 mg/kg to Japanese patients,might offer a clinical efficacy and safety that are compatible with data reported in North America and the European Union for a 0.9 mg/kg dose.
BACKGROUND AND PURPOSE-Based on previous studies comparing different recombinant tissue plasminogen activator (rt-PA) doses, we performed a clinical trial with 0.6 mg / kg, which is lower than the internationally approved dosage of 0.9 mg / kg, aiming to assess the efficacy and safety of alteplase in acute ischemic stroke for the Japanese. METHODS-Our prospective, multicenter, single-arm, open-label trial was designed with a target sample size of 100 patients. the primary end points were the proportion of patients with a modified Rankin Scale (mRS) score of 0 to 1 at 3 months and the incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours. Thresholds for these end points were determined by calculating 90% CIs of weighted averages derived from published reports. protocol was defined according to the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA stroke study with slight modifications .RESULTS-Among the 103 patients enrolled, 38 had an mRS of 0 to 1 at 3 months; this pro This incidence (5.8%) was lower than the threshold of 9.6% .CONCLUSIONS-In patients receiving 0.6 mg / kg alteplase, the outcome (36.9%) exceeded the predetermined threshold of 33.9%. sICH within 36 hours occurred in 6 patients and the incidence of sICH were comparable to published data for 0.9 mg / kg. These findings of that alteplase, when administered at 0.6 mg / kg to Japanese patients, might offer a clinical efficacy and safety that are compatible with data reported in North America and the European Union for a 0.9 mg / kg dose.