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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.

AbstractOBJECTIVES:
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.
AuthorsC Kawai, Y Yui, S Hosoda, M Nobuyoshi, S Suzuki, H Sato, F Takatsu, T Motomiya, K Kanmatsuse, K Kodama, Y Yabe, T Minamino, S Kimata, M Nakashima
JournalJournal of the American College of Cardiology (J Am Coll Cardiol) Vol. 29 Issue 7 Pg. 1447-53 (Jun 1997) ISSN: 0735-1097 [Print] United States
PMID9180103 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • E 6010
  • Epidermal Growth Factor
  • Tissue Plasminogen Activator
Topics
  • Aged
  • Coronary Vessels (drug effects)
  • Double-Blind Method
  • Epidermal Growth Factor (administration & dosage)
  • Female
  • Fibrinolysis (drug effects)
  • Humans
  • Injections, Intravenous
  • Male
  • Middle Aged
  • Myocardial Infarction (drug therapy)
  • Prospective Studies
  • Regional Blood Flow (drug effects)
  • Thrombolytic Therapy (methods)
  • Tissue Plasminogen Activator (administration & dosage)
  • Treatment Outcome

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