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Intravenous NPA for the treatment of infarcting myocardium early; InTIME-II, a double-blind comparison of single-bolus lanoteplase vs accelerated alteplase for the treatment of patients with acute myocardial infarction.

AbstractAIMS:
To compare the efficacy and safety of lanoteplase, a single-bolus thrombolytic drug derived from alteplase tissue plasminogen activator, with the established accelerated alteplase regimen in patients presenting within 6 h of onset of ST elevation acute myocardial infarction.
METHODS AND RESULTS:
15,078 patients were recruited from 855 hospitals worldwide and randomized in a 2:1 ratio to receive either lanoteplase 120 KU. kg(-1)as a single intravenous bolus, or up to 100 mg accelerated alteplase given over 90 min. The primary end-point was all-cause mortality at 30 days and the hypothesis was that the two treatments would be equivalent. By 30 days, 6.61% of alteplase-treated patients and 6.75% lanoteplase-treated patients had died (relative risk 1.02). Total stroke occurred in 1.53% alteplase- and 1.87% lanoteplase-treated patients (ns); haemorrhagic stroke rates were 0.64% alteplase and 1.12% lanoteplase (P=0.004). The net clinical deficit of 30-day death or non-fatal disabling stroke was 7.0% and 7.2%, respectively. By 6 months, 8.8% of alteplase-treated patients and 8.7% of lanoteplase-treated patients had died.
CONCLUSION:
Single-bolus weight-adjusted lanoteplase is an effective thrombolytic agent, equivalent to alteplase in terms of its impact on survival and with a comparable risk-benefit profile. The single-bolus regimen should shorten symptoms to treatment times and be especially convenient for emergency department or out-of-hospital administration.
AuthorsInTIME-II Investigators
JournalEuropean heart journal (Eur Heart J) Vol. 21 Issue 24 Pg. 2005-13 (Dec 2000) ISSN: 0195-668X [Print] England
PMID11102251 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
CopyrightCopyright 2000 The European Society of Cardiology.
Chemical References
  • Fibrinolytic Agents
  • lanoteplase
  • Tissue Plasminogen Activator
Topics
  • Aged
  • Double-Blind Method
  • Female
  • Fibrinolytic Agents (administration & dosage, therapeutic use)
  • Humans
  • Infusions, Intravenous
  • Intracranial Hemorrhages (epidemiology, etiology)
  • Male
  • Middle Aged
  • Myocardial Infarction (drug therapy, physiopathology)
  • Risk
  • Stroke (epidemiology, etiology)
  • Survival Analysis
  • Thrombolytic Therapy
  • Tissue Plasminogen Activator (administration & dosage, therapeutic use)

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