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Peter Sandercock On behalf of the IST-3 Collaborative Group UK Stroke Forum

Thrombolysis for stroke & remaining uncertainties after ECASS3; clues from the type of patients recruited in IST-3. Peter Sandercock On behalf of the IST-3 Collaborative Group UK Stroke Forum Glasgow, 3 rd December 2009. Uncertainties* about thrombolysis in acute ischaemic stroke.

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Peter Sandercock On behalf of the IST-3 Collaborative Group UK Stroke Forum

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  1. Thrombolysis for stroke &remaining uncertainties after ECASS3; clues from the type of patients recruited in IST-3 Peter Sandercock On behalf of the IST-3 Collaborative Group UK Stroke Forum Glasgow, 3rd December 2009

  2. Uncertainties* about thrombolysis in acute ischaemic stroke • Is the upper age limit of 80 years justified? • What key features identify patients most likely to benefit? • Severity (e.g. NIHSS)? • Stroke syndrome (LACI, TACI, POCI)? • Radiological (e.g. Hyperdense artery, WML)? • What is the latest time for net benefit? • Baseline features of IST-3 patients could indicate what participating clinicians are most uncertain about *Wardlaw et al BMJ 2009 339; b4584

  3. IST-3 trial: eligibility If patient fits main eligibility criteria, Clinician/patient/family discuss. If: • ClearINDICATION FORrt-PA  TREAT (i.e. meets terms of current licence and patient agrees) • Clear CONTRAINDICATION TOrt-PA  DON’T TREAT • rt-PA ‘PROMISING BUT UNPROVEN’ RANDOMISE

  4. IST - 3 Methods & data • Randomised, open, blinded outcomes study of i.v. rt-PA vs control, • Primary outcome: the proportion of patients alive and independent at six months • Randomisation by telephone or via web • Imaging: structural CT or MR + perfusion/angio data if available -> expert central review • Target 3100 patients by end June 2011 • Analysis of baseline data on the 1787 patients recruited by 6th September 2009

  5. Age Over 800 patients aged > 80 years

  6. OCSP clinical syndrome POCI LACI TACI PACI

  7. Severity: baseline NIHSS

  8. Time onset to randomisation 42% 33% 25%

  9. Trends in time onset to randomisation Median (hrs) 4.0 4.0 3.9 3.8 4.0

  10. Number of patients recruited per quarter year in each age and time stratum Age time(h)

  11. Expert’s opinion (blinded) of baseline scan

  12. Summary • The type of patients recruited reflects the ‘grey area of uncertainty’ of the participating clinicians • Broad entry criteria enable IST-3 to add evidence on effects of rt-PA among • Older patients • Mild, moderate and severe stroke • Patients treated up to 6 hours • Clinical subtypes (LACI,TACI, PACI, POCI) • IST-3 will help determine role of brain imaging • Structural CT, MR • (Vascular CT/MR Perfusion, angiography) in a subset

  13. Acknowledgements: The patients, the 116 participating hospitals, the Data Monitoring Committee, the MRC Steering Committee, the Expert Image Reading Panel, the International Advisory Board, the Event adjudication panel, and:

  14. IST-3. A large randomised trial: can a wider variety of patients be treated with iv therapy? Target: 3100 patients by mid 2011

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