The third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke

Sandercock, Peter;Lindley, Richard;Wardlaw, Joanna;Dennis, Martin;Lyrer, Phillippe;et.al.
(2008) Trials — Vol. 9, n° 17, p. 1-17 (2008)

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Authors
  • Sandercock, Peter
    Author
  • Lindley, Richard
    Author
  • Wardlaw, Joanna
    Author
  • Dennis, Martin
    Author
  • Peeters, AndréUCLouvain
    Author
  • Lyrer, Phillippe
    Author
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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).
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Sandercock, P., Lindley, R., Wardlaw, J., Dennis, M., Lewis, S., Venables, G., Kobayashi, A., Czlonkowska, A., Berge, E., Slot, K. B., Murray, V., Peeters, A., Hankey, G., Matz, K., Brainin, M., Ricci, S., Celani, M. G., Righetti, E., Cantisani, T., et al. (2008). The third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke. Trials, 9(17), 1-17. https://doi.org/10.1186/1745-6215-9-37 (Original work published 2008)