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Baseline characteristics of the 3035 patients recruited in IST3

Baseline characteristics of the 3035 patients recruited in IST3. Peter Sandercock On behalf of the IST3 collaborative group UKSF Glasgow 30th November 2011. These results published today www.trialsjournal.com. Main features of IST - 3.

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Baseline characteristics of the 3035 patients recruited in IST3

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  1. Baseline characteristics of the 3035 patients recruited in IST3 Peter Sandercock On behalf of the IST3 collaborative group UKSF Glasgow 30th November 2011 These results published today www.trialsjournal.com

  2. Main features of IST - 3 Prospective, randomised, open, blinded endpoint (PROBE) study of i.v. rt-PA vs control, Target 3100 patients < 6 h of acute ischaemic stroke Primary outcome: the proportion of patients alive and independent at six months Randomisation by telephone or internet with minimisation to balance on key prognostic factors Baseline & F/U Imaging: CT or MR, Blinded central expert panel review of scans Option to collect perfusion/angio data.

  3. IST-3 trial: eligibility and randomisation If patient fits main eligibility/exclusion criteria clinician/patient/family discuss. If there is a: Clear INDICATION FOR rt-PA→TREAT (i.e. meets terms of current licence and patient agrees) Clear CONTRAINDICATION TO rt-PA →DON’T TREAT rt-PA ‘PROMISING BUT UNPROVEN’→RANDOMISE

  4. Recruitment 2000-2011 Pilot - Expansion - Main MRC phase

  5. Recruitment by country

  6. Age: 1617 (53%) patients > 80

  7. Stroke severity: NIHSS

  8. Time to randomisation 39% 33% 28%

  9. Size of main subgroups

  10. Summary • IST3 will provide data on effects of rtPA in types of patients currently outside the EU approval • If positive, IST3 could justify the treatment of some patients currently excluded from treatment in EU (e.g. aged > 80) • If negative or neutral, IST3 may limit ‘off-label’ use by clarifying the ‘outer limits of benefit’ for some patients • The trial will provide randomised evidence on the importance (or not) of • ‘clinical contraindications’ (e.g. DM + prior stroke),1 • the use of advanced imaging • other factors 1. Demaerschalk, 2. Mishra et al Neurology 2011

  11. Acknowledgements: The 3035 patients, the 156 hospitals in the IST-3 group, the Data Monitoring Committee, the MRC Steering Committee, Image Reading Panel, Event adjudication panel, International Advisory Board. Funded by:

  12. How many would have met the EU approval for rtPA? • Would meet the 2003 approval:1 61 (2%) • Would meet the 2011 approval:2 350 (13%) • age <80, delay from onset to randomisation <3hours, NIHSS 6 - 25, SBP <=185, DBP <= 110, 2.7 <= glucose <=22 and no history of the combination of prior stroke and diabetes mellitus • all the above + the time window was extended to 4.5 hours

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