Published in:
Open Access
01-12-2008 | Study protocol
The third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke
Authors:
Peter Sandercock, Richard Lindley, Joanna Wardlaw, Martin Dennis, Steff Lewis, Graham Venables, Adam Kobayashi, Anna Czlonkowska, Eivind Berge, Karsten Bruins Slot, Veronica Murray, Andre Peeters, Graeme Hankey, Karl Matz, Michael Brainin, Stefano Ricci, Maria Grazia Celani, Enrico Righetti, Teresa Cantisani, Gord Gubitz, Steve Phillips, Antonio Arauz, Kameshwar Prasad, Manuel Correia, Phillippe Lyrer, the IST-3 collaborative group
Published in:
Trials
|
Issue 1/2008
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Abstract
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