title: A pilot study of a new thrombolytic agent for acute ischemic stroke in Taiwan within a five-hour window.
abstract: OBJECTIVE
  This study was the first clinical trial in Taiwan of a new thrombolytic agent human tissue urokinase type plasminogen activator (HTUPA) in patients with acute ischemic stroke.
  
  
  METHODS
  Patients were treated with a single bolus intravenous HTUPA under an open-label dose escalation design within 5 hours after symptom onset. Safety outcomes were assessed by symptomatic and asymptomatic intracerebral hemorrhage (ICH) as well as other bleeding episodes. Preliminary efficacy was measured by National Institutes of Health Stroke Scale (NIHSS).
  
  
  RESULTS
  Three doses of HTUPA (0.3 mg/kg, 0.35 mg/kg, and 0.4 mg/kg) were administered to 33 patients, with the majority of patients (n=29) receiving 0.3 mg/kg. Two cases of fatal ICH occurred: 1 in the patient who received 0.4 mg/kg and the other in the 0.3 mg/kg group. Asymptomatic ICH occurred in 6 patients. Other treatment-related serious adverse events were ecchymosis, hematuria, and upper gastrointestinal bleeding, which were completely recovered. At day 90, in patients treated with 0.3 mg/kg within a 0- to 5-hour window, 34% reached NIHSS scores 0 to 1, whereas of those treated within 0 to 3 hours, 86% reached this score.
  
  
  CONCLUSIONS
  Intravenous HTUPA, given at 0.3 mg/kg as a bolus injection within 5 hours after symptom onset, had an acceptable safety and efficacious profile in patients with acute ischemic stroke.
authors.affiliation: Department of Neurology, Taipei Veterans General Hospital, Taiwan. hhhu@vghtpe.gov.tw
authors.forename: Han-Hwa
authors.initials: HH
authors.lastname: Hu
authors.forename: Michael Mu-Huo
authors.initials: MM
authors.lastname: Teng
authors.forename: Li-Chi
authors.initials: LC
authors.lastname: Hsu
authors.forename: Wen-Jang
authors.initials: WJ
authors.lastname: Wong
authors.forename: Lee-Min
authors.initials: LM
authors.lastname: Wang
authors.forename: Yun-On
authors.initials: YO
authors.lastname: Luk
authors.forename: Chang-Ming
authors.initials: CM
authors.lastname: Chern
authors.forename: Bing-Wen
authors.initials: BW
authors.lastname: Soong
authors.forename: Wen-Yung
authors.initials: WY
authors.lastname: Sheng
mesh_terms: D000368:Aged; D002545:Brain Ischemia / Q000473:pathology*; D002543:Cerebral Hemorrhage / Q000175:diagnosis / Q000188:drug therapy; D005260:Female; D005343:Fibrinolytic Agents / Q000494:pharmacology*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012720:Severity of Illness Index; D020521:Stroke / Q000188:drug therapy* / Q000473:pathology*; D013624:Taiwan; D015912:Thrombolytic Therapy / Q000379:methods*; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage*; D016896:Treatment Outcome; D014568:Urokinase-Type Plasminogen Activator / Q000008:administration & dosage*
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator; D014568:Urokinase-Type Plasminogen Activator