[New era has begun since the approval of thrombolytic therapy for acute ischemic stroke in Japan].
Japan Alteplase Clinical Trial (J-ACT), a prospective multicenter clinical trial, demonstrated good clinical outcome in patients treated with 0.6 mg/kg of alteplase, being similar to that with 0.9 mg/kg of alteplase in the National Institute of Neurological Disorders and Stroke (NINDS) study. On that basis, intravenous aplteplase therapy was approved in Japan in October, 2005. This therapy resulted in better efficacy and similar safety in our stroke care unit (SCU) as compared to J-ACT or other clinical studies performed outside Japan. Our nation-wide survey demonstrated that the approval of the therapy resulted in dramatic changes in the processes of management for acute stroke patients. Preliminary results of the post-marketing surveillance study of alteplase in Japan suggested similar efficacy and safety profiles of the therapy to those reported by a European study, Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST). There are several limitations and problems in the therapy that will be overcome by new therapeutic strategies including the development of new-generation therombolytic agents having longer therapeutic time window, applications of magnetic resonance imaging techniques, and combination therapies with neuroprotective agents, sonothrombolysis, intraarterial application of the agent, or mechanical thrombectomy.
Minematsu
Kazuo
K
Cerebrovascular Division, Department of Medicine, National Cardiovascular Center.
D017277:Drug Approval; D004359:Drug Therapy, Combination; D004632:Emergency Medical Services; D006801:Humans; D007262:Infusions, Intravenous; D007564:Japan; D008279:Magnetic Resonance Imaging; D018696:Neuroprotective Agents / Q000008:administration & dosage; D011994:Recombinant Proteins / Q000008:administration & dosage; D020521:Stroke / Q000175:diagnosis / Q000188:drug therapy*; D017131:Thrombectomy; D015912:Thrombolytic Therapy; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage*
D018696:Neuroprotective Agents; D011994:Recombinant Proteins; D010959:Tissue Plasminogen Activator