Journal article

Effects of alteplase for acute stroke according to criteria defining the European Union and United States marketing authorizations: Individual-patient-data meta-analysis of randomized trials

W Hacke, P Lyden, J Emberson, C Baigent, L Blackwell, G Albers, E Bluhmki, T Brott, G Cohen, SM Davis, GA Donnan, JC Grotta, G Howard, M Kaste, M Koga, R von Kummer, MG Lansberg, RI Lindley, JM Olivot, M Parsons Show all

International Journal of Stroke | SAGE PUBLICATIONS LTD | Published : 2018

Abstract

Background: The recommended maximum age and time window for intravenous alteplase treatment of acute ischemic stroke differs between the Europe Union and United States. Aims: We compared the effects of alteplase in cohorts defined by the current Europe Union or United States marketing approval labels, and by hypothetical revisions of the labels that would remove the Europe Union upper age limit or extend the United States treatment time window to 4.5 h. Methods: We assessed outcomes in an individual-patient-data meta-analysis of eight randomized trials of intravenous alteplase (0.9 mg/kg) versus control for acute ischemic stroke. Outcomes included: excellent outcome (modified Rankin score 0–..

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Grants

Awarded by Medical Research Council


Funding Acknowledgements

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The Stroke Thrombolysis Trialists' Collaboration is coordinated by the MRC Population Health Research Unit, which is part of the Clinical Trial Service Unit & Epidemiological Studies Unit at the University of Oxford, UK. The Unit receives core funding from the UK Medical Research Council and the British Heart Foundation. This work also received support from the University of Glasgow and University of Edinburgh.