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

<p>Abstract</p> <p>Background</p> <p>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...

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Main Authors: Sandercock Peter, Lindley Richard, Wardlaw Joanna, Dennis Martin, Innes Karen, Cohen Geoff, Whiteley Will, Perry David, Soosay Vera, Buchanan David, Venables Graham, Czlonkowska Anna, Kobayashi Adam, Berge Eivind, Slot Karsten, Murray Veronica, Peeters Andre, Hankey Graeme J, Matz Karl, Brainin Michael, Ricci Stefano, Cantisani Teresa A, Gubitz Gordon, Phillips Stephen J, Antonio Arauz, Correia Manuel, Lyrer Phillippe, Kane Ingrid, Lundstrom Erik
Format: Article
Language:English
Published: BMC 2011-11-01
Series:Trials
Online Access:http://www.trialsjournal.com/content/12/1/252
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author Sandercock Peter
Lindley Richard
Wardlaw Joanna
Dennis Martin
Innes Karen
Cohen Geoff
Whiteley Will
Perry David
Soosay Vera
Buchanan David
Venables Graham
Czlonkowska Anna
Kobayashi Adam
Berge Eivind
Slot Karsten
Murray Veronica
Peeters Andre
Hankey Graeme J
Matz Karl
Brainin Michael
Ricci Stefano
Cantisani Teresa A
Gubitz Gordon
Phillips Stephen J
Antonio Arauz
Correia Manuel
Lyrer Phillippe
Kane Ingrid
Lundstrom Erik
author_facet Sandercock Peter
Lindley Richard
Wardlaw Joanna
Dennis Martin
Innes Karen
Cohen Geoff
Whiteley Will
Perry David
Soosay Vera
Buchanan David
Venables Graham
Czlonkowska Anna
Kobayashi Adam
Berge Eivind
Slot Karsten
Murray Veronica
Peeters Andre
Hankey Graeme J
Matz Karl
Brainin Michael
Ricci Stefano
Cantisani Teresa A
Gubitz Gordon
Phillips Stephen J
Antonio Arauz
Correia Manuel
Lyrer Phillippe
Kane Ingrid
Lundstrom Erik
author_sort Sandercock Peter
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Design</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusion</p> <p>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.</p> <p>Trial registration</p> <p><a href="http://www.controlled-trials.com/ISRCTN25765518">ISRCTN25765518</a></p>
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spelling doaj.art-03cca3e3b5d748dc8c2c12b4e11038712022-12-21T22:02:52ZengBMCTrials1745-62152011-11-0112125210.1186/1745-6215-12-252Update on the third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke and baseline features of the 3035 patients recruitedSandercock PeterLindley RichardWardlaw JoannaDennis MartinInnes KarenCohen GeoffWhiteley WillPerry DavidSoosay VeraBuchanan DavidVenables GrahamCzlonkowska AnnaKobayashi AdamBerge EivindSlot KarstenMurray VeronicaPeeters AndreHankey Graeme JMatz KarlBrainin MichaelRicci StefanoCantisani Teresa AGubitz GordonPhillips Stephen JAntonio ArauzCorreia ManuelLyrer PhillippeKane IngridLundstrom Erik<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Design</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusion</p> <p>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.</p> <p>Trial registration</p> <p><a href="http://www.controlled-trials.com/ISRCTN25765518">ISRCTN25765518</a></p>http://www.trialsjournal.com/content/12/1/252
spellingShingle Sandercock Peter
Lindley Richard
Wardlaw Joanna
Dennis Martin
Innes Karen
Cohen Geoff
Whiteley Will
Perry David
Soosay Vera
Buchanan David
Venables Graham
Czlonkowska Anna
Kobayashi Adam
Berge Eivind
Slot Karsten
Murray Veronica
Peeters Andre
Hankey Graeme J
Matz Karl
Brainin Michael
Ricci Stefano
Cantisani Teresa A
Gubitz Gordon
Phillips Stephen J
Antonio Arauz
Correia Manuel
Lyrer Phillippe
Kane Ingrid
Lundstrom Erik
Update on the third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke and baseline features of the 3035 patients recruited
Trials
title Update on the third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke and baseline features of the 3035 patients recruited
title_full Update on the third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke and baseline features of the 3035 patients recruited
title_fullStr Update on the third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke and baseline features of the 3035 patients recruited
title_full_unstemmed Update on the third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke and baseline features of the 3035 patients recruited
title_short Update on the third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke and baseline features of the 3035 patients recruited
title_sort update on the third international stroke trial ist 3 of thrombolysis for acute ischaemic stroke and baseline features of the 3035 patients recruited
url http://www.trialsjournal.com/content/12/1/252
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