title: Treatment of acute stroke with recombinant tissue plasminogen activator and abciximab.
abstract: OBJECTIVE
  Preclinical data suggest that treatment of acute ischemic stroke (AIS) with the combination of recombinant tissue plasminogen activator (rt-PA) and abciximab may increase efficacy and decrease the rate of symptomatic intracranial hemorrhage (sICH). The authors report pilot data of five AIS patients with half-dose rt-PA and abciximab as part of an ongoing phase I safety trial with sICH as the primary outcome.
  
  
  METHODS
  Five patients with AIS were treated with the combination of half-dose rt-PA (0.45 mg/kg) and abciximab (0.25 mg/kg bolus followed by a 0.125 microg/kg/min infusion over 12 hours). Head computed tomographic scan was obtained after 24 hours of treatment onset.
  
  
  RESULTS
  Four patients received the combination of half-dose abciximab and rt-PA without major complications. One patient experienced a parenchymal hematoma type-1 ICH without significant decline of his neurological status. The average National Institutes of Health Stroke Scale change at discharge in comparison with pretreatment was -5.4 +/- 7.0, and the median change was 6 points with a range of 4 points (worsening) to -13 points (improvement) (p=0.07) based on a one-sided t-test.
  
  
  CONCLUSIONS
  Administration of rt-PA and abciximab to AIS patients was completed without difficulty. No sICH were observed; however, 20% (1 out of 5) experienced an asymptomatic ICH. Based on our observation of five patients, there was a trend of treatment efficacy; however, these results need to be confirmed in a larger-scale placebo-controlled clinical trial.
authors.affiliation: Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI 48202, USA. morris@neuro.hfh.edu
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Morris
authors.forename: Brian
authors.initials: B
authors.lastname: Silver
authors.forename: Panos
authors.initials: P
authors.lastname: Mitsias
authors.forename: Christopher
authors.initials: C
authors.lastname: Lewandowski
authors.forename: Suresh
authors.initials: S
authors.lastname: Patel
authors.forename: Sheila
authors.initials: S
authors.lastname: Daley
authors.forename: Zheng G
authors.initials: ZG
authors.lastname: Zhang
authors.forename: Mei
authors.initials: M
authors.lastname: Lu
mesh_terms: D000077284:Abciximab; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000925:Anticoagulants / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011994:Recombinant Proteins / Q000627:therapeutic use; D020521:Stroke / Q000188:drug therapy*; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D005343:Fibrinolytic Agents; D007140:Immunoglobulin Fab Fragments; D011994:Recombinant Proteins; D010959:Tissue Plasminogen Activator; D000077284:Abciximab