Abstract | AIMS: 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.
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Authors | InTIME-II Investigators |
Journal | European heart journal
(Eur Heart J)
Vol. 21
Issue 24
Pg. 2005-13
(Dec 2000)
ISSN: 0195-668X [Print] England |
PMID | 11102251
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | Copyright 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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