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The third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke
BACKGROUND: Intravenous recombinant tissue plasminogen activator (rt-PA) is approved for use in selected patients with ischaemic stroke within 3 hours of symptom onset. IST-3 seeks to determine whether a wider range of patients may benefit. DESIGN: International, multi-centre, prospective, randomize...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2008
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2442584/ https://www.ncbi.nlm.nih.gov/pubmed/18559104 http://dx.doi.org/10.1186/1745-6215-9-37 |
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author | Sandercock, Peter Lindley, Richard Wardlaw, Joanna Dennis, Martin Lewis, Steff Venables, Graham Kobayashi, Adam Czlonkowska, Anna Berge, Eivind Slot, Karsten Bruins Murray, Veronica Peeters, Andre Hankey, Graeme Matz, Karl Brainin, Michael Ricci, Stefano Celani, Maria Grazia Righetti, Enrico Cantisani, Teresa Gubitz, Gord Phillips, Steve Arauz, Antonio Prasad, Kameshwar Correia, Manuel Lyrer, Phillippe |
author_facet | Sandercock, Peter Lindley, Richard Wardlaw, Joanna Dennis, Martin Lewis, Steff Venables, Graham Kobayashi, Adam Czlonkowska, Anna Berge, Eivind Slot, Karsten Bruins Murray, Veronica Peeters, Andre Hankey, Graeme Matz, Karl Brainin, Michael Ricci, Stefano Celani, Maria Grazia Righetti, Enrico Cantisani, Teresa Gubitz, Gord Phillips, Steve Arauz, Antonio Prasad, Kameshwar Correia, Manuel Lyrer, Phillippe |
author_sort | Sandercock, Peter |
collection | PubMed |
description | BACKGROUND: Intravenous recombinant tissue plasminogen activator (rt-PA) is approved for use in selected patients with ischaemic stroke within 3 hours of symptom onset. IST-3 seeks to determine whether a wider range of patients may benefit. DESIGN: International, multi-centre, prospective, randomized, open, blinded endpoint (PROBE) trial of intravenous rt-PA in acute ischaemic stroke. Suitable patients must be assessed and able to start treatment within 6 hours of developing symptoms, and brain imaging must have excluded intracerebral haemorrhage. With 1000 patients, the trial can detect a 7% absolute difference in the primary outcome. With3500 patients, it can detect a 4.0% absolute benefit & with 6000, (mostly treated between 3 & 6 hours), it can detect a 3% benefit. TRIAL PROCEDURES: Patients are entered into the trial by telephoning a fast, secure computerised central randomisation system or via a secure web interface. Repeat brain imaging must be performed at 24–48 hours. The scans are reviewed 'blind' by expert readers. The primary measure of outcome is the proportion of patients alive and independent (Modified Rankin 0–2) at six months (assessed via a postal questionnaire mailed directly to the patient). Secondary outcomes include: events within 7 days (death, recurrent stroke, symptomatic intracranial haemorrhage), outcome at six months (death, functional status, EuroQol). TRIAL REGISTRATION: ISRCTN25765518 |
format | Text |
id | pubmed-2442584 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2008 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-24425842008-07-02 The third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke Sandercock, Peter Lindley, Richard Wardlaw, Joanna Dennis, Martin Lewis, Steff Venables, Graham Kobayashi, Adam Czlonkowska, Anna Berge, Eivind Slot, Karsten Bruins Murray, Veronica Peeters, Andre Hankey, Graeme Matz, Karl Brainin, Michael Ricci, Stefano Celani, Maria Grazia Righetti, Enrico Cantisani, Teresa Gubitz, Gord Phillips, Steve Arauz, Antonio Prasad, Kameshwar Correia, Manuel Lyrer, Phillippe Trials Study Protocol BACKGROUND: Intravenous recombinant tissue plasminogen activator (rt-PA) is approved for use in selected patients with ischaemic stroke within 3 hours of symptom onset. IST-3 seeks to determine whether a wider range of patients may benefit. DESIGN: International, multi-centre, prospective, randomized, open, blinded endpoint (PROBE) trial of intravenous rt-PA in acute ischaemic stroke. Suitable patients must be assessed and able to start treatment within 6 hours of developing symptoms, and brain imaging must have excluded intracerebral haemorrhage. With 1000 patients, the trial can detect a 7% absolute difference in the primary outcome. With3500 patients, it can detect a 4.0% absolute benefit & with 6000, (mostly treated between 3 & 6 hours), it can detect a 3% benefit. TRIAL PROCEDURES: Patients are entered into the trial by telephoning a fast, secure computerised central randomisation system or via a secure web interface. Repeat brain imaging must be performed at 24–48 hours. The scans are reviewed 'blind' by expert readers. The primary measure of outcome is the proportion of patients alive and independent (Modified Rankin 0–2) at six months (assessed via a postal questionnaire mailed directly to the patient). Secondary outcomes include: events within 7 days (death, recurrent stroke, symptomatic intracranial haemorrhage), outcome at six months (death, functional status, EuroQol). TRIAL REGISTRATION: ISRCTN25765518 BioMed Central 2008-06-17 /pmc/articles/PMC2442584/ /pubmed/18559104 http://dx.doi.org/10.1186/1745-6215-9-37 Text en Copyright © 2008 Sandercock et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 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. |
spellingShingle | Study Protocol Sandercock, Peter Lindley, Richard Wardlaw, Joanna Dennis, Martin Lewis, Steff Venables, Graham Kobayashi, Adam Czlonkowska, Anna Berge, Eivind Slot, Karsten Bruins Murray, Veronica Peeters, Andre Hankey, Graeme Matz, Karl Brainin, Michael Ricci, Stefano Celani, Maria Grazia Righetti, Enrico Cantisani, Teresa Gubitz, Gord Phillips, Steve Arauz, Antonio Prasad, Kameshwar Correia, Manuel Lyrer, Phillippe The third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke |
title | The third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke |
title_full | The third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke |
title_fullStr | The third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke |
title_full_unstemmed | The third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke |
title_short | The third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke |
title_sort | third international stroke trial (ist-3) of thrombolysis for acute ischaemic stroke |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2442584/ https://www.ncbi.nlm.nih.gov/pubmed/18559104 http://dx.doi.org/10.1186/1745-6215-9-37 |
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