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Update on the third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke and baseline features of the 3035 patients recruited

Title: Update on the third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke and baseline features of the 3035 patients recruited
Authors: Sandercock, P
Lindley, R
Wardlaw, J
Dennis, M
Innes, K
Cohen, G
Whiteley, W
Perry, D
Soosay, V
Buchanan, D
Venables, G
Czlonkowska, A
Kobayashi, A
Berge, E
Slot, KB
Murray, V
Peeters, A
Hankey, GJ
Matz, K
Brainin, M
Ricci, S
Cantisani, TA
Gubitz, G
Phillips, SJ
Antonio, A
Correia, M
Lyrer, P
Kane, I
Lundstrom, E
Item Type: Journal Article
Abstract: Background Intravenous recombinant tissue plasminogen activator (rtPA) is approved in Europe for use in patients with acute ischaemic stroke who meet strictly defined criteria. IST-3 sought to improve the external validity and precision of the estimates of the overall treatment effects (efficacy and safety) of rtPA in acute ischaemic stroke, and to determine whether a wider range of patients might benefit. Design International, multi-centre, prospective, randomized, open, blinded endpoint (PROBE) trial of intravenous rtPA in acute ischaemic stroke. Suitable patients had to be assessed and able to start treatment within 6 hours of developing symptoms, and brain imaging must have excluded intracranial haemorrhage and stroke mimics. Results The initial pilot phase was double blind and then, on 01/08/2003, changed to an open design. Recruitment began on 05/05/2000 and closed on 31/07/2011, by which time 3035 patients had been included, only 61 (2%) of whom met the criteria for the 2003 European approval for thrombolysis. 1617 patients were aged over 80 years at trial entry. The analysis plan will be finalised, without reference to the unblinded data, and published before the trial data are unblinded in early 2012. The main trial results will be presented at the European Stroke Conference in Lisbon in May 2012 with the aim to publish simultaneously in a peer-reviewed journal. The trial result will be presented in the context of an updated Cochrane systematic review. We also intend to include the trial data in an individual patient data meta-analysis of all the relevant randomised trials. Conclusion The data from the trial will: improve the external validity and precision of the estimates of the overall treatment effects (efficacy and safety) of iv rtPA in acute ischaemic stroke; provide: new evidence on the balance of risk and benefit of intravenous rtPA among types of patients who do not clearly meet the terms of the current EU approval; and, provide the first large-scale randomised evidence on effects in patients over 80, an age group which had largely been excluded from previous acute stroke trials. Trial registration ISRCTN25765518
Issue Date: 30-Nov-2011
Date of Acceptance: 30-Nov-2011
URI: http://hdl.handle.net/10044/1/85253
DOI: 10.1186/1745-6215-12-252
ISSN: 1745-6215
Publisher: BioMed Central
Start Page: 1
End Page: 9
Journal / Book Title: Trials
Volume: 12
Copyright Statement: © 2011 Sandercock et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Keywords: Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
ALTEPLASE
Acute Disease
Brain Ischemia
Double-Blind Method
Fibrinolytic Agents
Humans
Prospective Studies
Sample Size
Stroke
Thrombolytic Therapy
Tissue Plasminogen Activator
IST-3 collaborative group
Humans
Brain Ischemia
Acute Disease
Tissue Plasminogen Activator
Fibrinolytic Agents
Thrombolytic Therapy
Prospective Studies
Double-Blind Method
Sample Size
Stroke
Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
ALTEPLASE
1102 Cardiorespiratory Medicine and Haematology
1103 Clinical Sciences
Cardiovascular System & Hematology
General & Internal Medicine
Publication Status: Published
Article Number: ARTN 252
Online Publication Date: 2011-11-30
Appears in Collections:Department of Brain Sciences



This item is licensed under a Creative Commons License Creative Commons