The third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke
<p>Abstract</p> <p>Background</p> <p>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.</...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2008-06-01
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| Series: | Trials |
| Online Access: | http://www.trialsjournal.com/content/9/1/37 |
| _version_ | 1811315138777579520 |
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| author | Cantisani Teresa Righetti Enrico Celani Maria Ricci Stefano Brainin Michael Matz Karl Hankey Graeme Peeters Andre Murray Veronica Slot Karsten Berge Eivind Czlonkowska Anna Kobayashi Adam Venables Graham Lewis Steff Dennis Martin Wardlaw Joanna Lindley Richard Sandercock Peter Gubitz Gord Phillips Steve Arauz Antonio Prasad Kameshwar Correia Manuel Lyrer Phillippe |
| author_facet | Cantisani Teresa Righetti Enrico Celani Maria Ricci Stefano Brainin Michael Matz Karl Hankey Graeme Peeters Andre Murray Veronica Slot Karsten Berge Eivind Czlonkowska Anna Kobayashi Adam Venables Graham Lewis Steff Dennis Martin Wardlaw Joanna Lindley Richard Sandercock Peter Gubitz Gord Phillips Steve Arauz Antonio Prasad Kameshwar Correia Manuel Lyrer Phillippe |
| author_sort | Cantisani Teresa |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Design</p> <p>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.</p> <p>Trial procedures</p> <p>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).</p> <p>Trial registration</p> <p>ISRCTN25765518</p> |
| first_indexed | 2024-04-13T11:24:55Z |
| format | Article |
| id | doaj.art-11138270590b452185c170643c4280e5 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T11:24:55Z |
| publishDate | 2008-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-11138270590b452185c170643c4280e52022-12-22T02:48:43ZengBMCTrials1745-62152008-06-01913710.1186/1745-6215-9-37The third international stroke trial (IST-3) of thrombolysis for acute ischaemic strokeCantisani TeresaRighetti EnricoCelani MariaRicci StefanoBrainin MichaelMatz KarlHankey GraemePeeters AndreMurray VeronicaSlot KarstenBerge EivindCzlonkowska AnnaKobayashi AdamVenables GrahamLewis SteffDennis MartinWardlaw JoannaLindley RichardSandercock PeterGubitz GordPhillips SteveArauz AntonioPrasad KameshwarCorreia ManuelLyrer Phillippe<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Design</p> <p>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.</p> <p>Trial procedures</p> <p>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).</p> <p>Trial registration</p> <p>ISRCTN25765518</p>http://www.trialsjournal.com/content/9/1/37 |
| spellingShingle | Cantisani Teresa Righetti Enrico Celani Maria Ricci Stefano Brainin Michael Matz Karl Hankey Graeme Peeters Andre Murray Veronica Slot Karsten Berge Eivind Czlonkowska Anna Kobayashi Adam Venables Graham Lewis Steff Dennis Martin Wardlaw Joanna Lindley Richard Sandercock Peter 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 Trials |
| 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 |
| url | http://www.trialsjournal.com/content/9/1/37 |
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