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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.
MedLine Citation:
PMID:  21960585     Owner:  NLM     Status:  Publisher    
BACKGROUND AND PURPOSE: 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.
Masatoshi Koga; Yoshiaki Shiokawa; Jyoji Nakagawara; Eisuke Furui; Kazumi Kimura; Hiroshi Yamagami; Yasushi Okada; Yasuhiro Hasegawa; Kazuomi Kario; Satoshi Okuda; Kaoru Endo; Tetsuya Miyagi; Masato Osaki; Kazuo Minematsu; Kazunori Toyoda
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-9-29
Journal Detail:
Title:  Stroke; a journal of cerebral circulation     Volume:  -     ISSN:  1524-4628     ISO Abbreviation:  -     Publication Date:  2011 Sep 
Date Detail:
Created Date:  2011-9-30     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0235266     Medline TA:  Stroke     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
From the National Cerebral and Cardiovascular Center, Suita, Japan; Kyorin University School of Medicine, Mitaka, Japan; Nakamura Memorial Hospital, Sapporo, Japan; Kohnan Hospital, Sendai, Japan; Kawasaki Medical School, Kurashiki, Japan; Kobe City Medical Center General Hospital, Kobe, Japan; NHO Kyushu Medical Center, Fukuoka, Japan; St Marianna University School of Medicine, Kawasaki, Japan; Jichi Medical University School of Medicine, Shimotsuke, Japan; and NHO Nagoya Medical Center, Nagoya, Japan.
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