title: Guidelines for the intravenous application of recombinant tissue-type plasminogen activator (alteplase), the second edition, October 2012: a guideline from the Japan Stroke Society.
abstract: In Japan, intravenous alteplase, a recombinant tissue-type plasminogen activator (rt-PA), was approved for an indication of ischemic stroke in 2005 on the basis of the results of a clinical trial with a unique dose of the drug (0.6 mg/kg). The Japan Stroke Society published the guidelines for intravenous application of rt-PA and organized training sessions for proper use all over Japan in an effort to promote the safe, widespread use of intravenous alteplase. Seven years following its approval, clinical experience with intravenous alteplase has accumulated, additional evidence of intravenous alteplase has been found in Japan and overseas, and the medical environment has substantially changed, including approvals for new drugs and medical devices. Notably, the use of alteplase in the extended therapeutic time window (within 4.5 hours of symptom onset) became covered by insurance in Japan in August 2012. To address these changing situations, we have decided to prepare the revised guidelines. In preparing the second edition, we took care to make its contents more practical by emphasizing information needed in clinical practice. While the first edition was developed with emphasis on safety in light of limited clinical experience with intravenous alteplase in Japan in 2005, this second edition is a substantial revision of the first edition mainly in terms of eligibility criteria, on the basis of accumulated evidence and the clinical experience.
authors.affiliation: National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Minematsu
authors.forename: Kazunori
authors.initials: K
authors.lastname: Toyoda
authors.forename: Teruyuki
authors.initials: T
authors.lastname: Hirano
authors.forename: Kazumi
authors.initials: K
authors.lastname: Kimura
authors.forename: Rei
authors.initials: R
authors.lastname: Kondo
authors.forename: Etsuro
authors.initials: E
authors.lastname: Mori
authors.forename: Jyoji
authors.initials: J
authors.lastname: Nakagawara
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Sakai
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Shiokawa
authors.forename: Norio
authors.initials: N
authors.lastname: Tanahashi
authors.forename: Masahiro
authors.initials: M
authors.lastname: Yasaka
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Katayama
authors.forename: Susumu
authors.initials: S
authors.lastname: Miyamoto
authors.forename: Akira
authors.initials: A
authors.lastname: Ogawa
authors.forename: Makoto
authors.initials: M
authors.lastname: Sasaki
authors.forename: Sadao
authors.initials: S
authors.lastname: Suga
authors.forename: Takenori
authors.initials: T
authors.lastname: Yamaguchi
mesh_terms: D061605:Administration, Intravenous; D004334:Drug Administration Schedule; D019317:Evidence-Based Medicine / Q000592:standards; D005343:Fibrinolytic Agents / Q000008:administration & dosage*; D006801:Humans; D007258:Informed Consent / Q000592:standards; D007564:Japan; D018579:Patient Selection; D011237:Predictive Value of Tests; D020521:Stroke / Q000175:diagnosis / Q000188:drug therapy*; D015912:Thrombolytic Therapy / Q000592:standards*; D061665:Time-to-Treatment / Q000592:standards*; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator