title: Low-dose intravenous recombinant tissue-type plasminogen activator therapy for patients with stroke outside European indications: Stroke Acute Management with Urgent Risk-factor Assessment and Improvement (SAMURAI) rtPA Registry.
abstract: OBJECTIVE
  The purpose of this study was to determine the safety and efficacy of intravenous recombinant tissue-type plasminogen activator (0.6 mg/kg alteplase) within 3 hours of stroke onset in Japanese patients outside the indications in the European license.
  
  
  METHODS
  Of the 600 patients who were treated with recombinant tissue-type plasminogen activator, 422 met the inclusion criteria of the European license (IN group) and 178 did not (OUT group).
  
  
  RESULTS
  The OUT group was inversely associated with any intracerebral hemorrhage (adjusted OR, 0.50; 95% CI, 0.29-0.84), positively associated with an unfavorable outcome (2.48; 1.55-3.94) and mortality (2.04; 1.02-4.04), and not associated with symptomatic intracerebral hemorrhage (0.53; 0.11-1.79) or complete independency (0.65; 0.40-1.03) after multivariate adjustment.
  
  
  CONCLUSIONS
  Functional and vital outcomes 3 months after low-dose recombinant tissue-type plasminogen activator in patients outside the European indications were less favorable compared with those included in the indications; however, the risk of intracerebral hemorrhage was not.
authors.affiliation: National Cerebral and Cardiovascular Center, 5-7-1 Fujishiro-dai, Suita 565-8565, Japan.
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Koga
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Shiokawa
authors.forename: Jyoji
authors.initials: J
authors.lastname: Nakagawara
authors.forename: Eisuke
authors.initials: E
authors.lastname: Furui
authors.forename: Kazumi
authors.initials: K
authors.lastname: Kimura
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yamagami
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Okada
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Hasegawa
authors.forename: Kazuomi
authors.initials: K
authors.lastname: Kario
authors.forename: Satoshi
authors.initials: S
authors.lastname: Okuda
authors.forename: Kaoru
authors.initials: K
authors.lastname: Endo
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Miyagi
authors.forename: Masato
authors.initials: M
authors.lastname: Osaki
authors.forename: Kazuo
authors.initials: K
authors.lastname: Minematsu
authors.forename: Kazunori
authors.initials: K
authors.lastname: Toyoda
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D002545:Brain Ischemia / Q000188:drug therapy* / Q000401:mortality; D002543:Cerebral Hemorrhage / Q000139:chemically induced*; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D007564:Japan; D008297:Male; D011379:Prognosis; D018570:Risk Assessment; D020521:Stroke / Q000188:drug therapy* / Q000401:mortality; D015912:Thrombolytic Therapy / Q000009:adverse effects*; D010959:Tissue Plasminogen Activator / Q000009:adverse effects* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator