title: A prospective, randomized, double-blind multicenter trial of a single bolus injection of the novel modified t-PA E6010 in the treatment of acute myocardial infarction: comparison with native t-PA. E6010 Study Group.
abstract: OBJECTIVE
  This prospective, randomized, double-blind multicenter trial evaluated the efficacy and safety of a single bolus injection of the novel modified tissue-type plasminogen activator (t-PA) E6010 in the treatment of acute myocardial infarction compared with that of native t-PA.
  
  
  BACKGROUND
  E6010 is a novel modified t-PA with a prolonged half-life (t1/2 alpha > or = 23 min) compared with native t-PA (t1/2 alpha = 4 min). E6010 can be administered in patients as a single intravenous bolus injection, and early recanalization can be expected.
  
  
  METHODS
  The efficacy of E6010 was compared with that of native t-PA in 199 patients with acute myocardial infarction who were treated within 6 h of onset in a prospective, randomized, double-blind multicenter trial. Patients were given either 0.22 mg/kg body weight of E6010 intravenously over 2 min or native t-PA (tisokinase) 28.8 mg or 14.4 million IU (10% of the total dose over 1 to 2 min, the remainder infused over 60 min).
  
  
  RESULTS
  The primary end point was the recanalization rate of the infarct-related coronary artery at 60 min after the start of treatment. Time to reperfusion was shorter in the E6010 group than in the native t-PA group. Thrombolysis in Myocardial Infarction flow grade 2 or 3 recanalization at 15, 30, 45 and 60 min after administration was observed in 37%, 62%, 74% and 79% (95% confidence interval [CI] 70% to 87%) of the E6010-treated patients and in 14%, 32%, 50% and 65% (95% CI 55% to 74%) of native t-PA-treated patients, respectively (p = 0.032 at 60 min).
  
  
  CONCLUSIONS
  The present study indicates that, compared with native t-PA, a single bolus injection of E6010 over 2 min produces a higher rate of early recanalization of the infarct-related coronary artery without fatal bleeding complications.
authors.affiliation: Kyoto University, Japan.
authors.forename: C
authors.initials: C
authors.lastname: Kawai
authors.forename: Y
authors.initials: Y
authors.lastname: Yui
authors.forename: S
authors.initials: S
authors.lastname: Hosoda
authors.forename: M
authors.initials: M
authors.lastname: Nobuyoshi
authors.forename: S
authors.initials: S
authors.lastname: Suzuki
authors.forename: H
authors.initials: H
authors.lastname: Sato
authors.forename: F
authors.initials: F
authors.lastname: Takatsu
authors.forename: T
authors.initials: T
authors.lastname: Motomiya
authors.forename: K
authors.initials: K
authors.lastname: Kanmatsuse
authors.forename: K
authors.initials: K
authors.lastname: Kodama
authors.forename: Y
authors.initials: Y
authors.lastname: Yabe
authors.forename: T
authors.initials: T
authors.lastname: Minamino
authors.forename: S
authors.initials: S
authors.lastname: Kimata
authors.forename: M
authors.initials: M
authors.lastname: Nakashima
mesh_terms: D000368:Aged; D003331:Coronary Vessels / Q000187:drug effects*; D004311:Double-Blind Method; D004815:Epidermal Growth Factor / Q000008:administration & dosage*; D005260:Female; D005342:Fibrinolysis / Q000187:drug effects; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy*; D011446:Prospective Studies; D012039:Regional Blood Flow / Q000187:drug effects; D015912:Thrombolytic Therapy / Q000379:methods*; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: C076356:E 6010; D004815:Epidermal Growth Factor; D010959:Tissue Plasminogen Activator