線溶療法 発症３時間以内の虚血性脳血管障害に対するＧＭＫ‐５２７（アルテプラーゼ）静注療法臨床試験の結果

Abstract

Treatment of acute ischemic stroke with alteplase, an intravenous recombinant tissue plasminogen activator (rt-PA) has been approved in 40 countries, but not yet in Japan. To assess the clinical applicability of this therapy in Japan, we conducted a single dose open label multicenter trial (Japan Alteplase Clinical Trial, J-ACT).Inclusion and exclusion criteria in this study were almost the same as NINDS rt-PA Stroke Study, except that excluded were patients with early ischemic changes>1/3 of the MCA territory on the pretreatment CT, mild stroke defined as the pretreatment NIH Stroke Scale (NIHSS) score 4 or less, and patients with coma. Patients received alteplase at dose of 0.6 mg/kg. The dose was chosen because of the results of a study for patients with acute myocardial infarction and the duteplase study for embolic stroke patients both carried out earlier in Japan. The modified Rankin Scale (mRS), NIHSS, and Barthel Index scores at 3 months from stroke onset were evaluated for outcome measures. Adverse events and symptomatic intracranial hemorrhage (s-ICH) were assessed within the initial 3 months.A total of 103 patients (78% for cardioembolic stroke) were enrolled. The baseline NIHSS scores were comparable to those in the NINDS trial. The incidence of s-ICH within 36 hours from treatment, and the ratio of good outcome (mRS 0-1) and mortality at 3 months were consistent with those in the NINDS trial. In con-clusion, the efficacy and safety of alteplase at 6.0 mg/kg in J-ACT was comparable to that at the 0.9 mg/kg in the NINDS trial.