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IST-3 Collaborators meeting

IST-3 Collaborators meeting. Barcelona, 27 th May 2010. Outline. Informed consent / GCP Update Effect of ECASS-3 Lancet pooled analysis Remaining uncertainties Recruitment: ‘countdown’ to 30/6/11! Maintain high data quality. Informed Consent.

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IST-3 Collaborators meeting

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  1. IST-3 Collaborators meeting Barcelona, 27th May 2010

  2. Outline • Informed consent / GCP • Update • Effect of ECASS-3 • Lancet pooled analysis • Remaining uncertainties • Recruitment: ‘countdown’ to 30/6/11! • Maintain high data quality

  3. Informed Consent • Oral and written information given to the patient by the investigator • Before participation in trial • Enough time and opportunity for questions and reflection

  4. Informed Consent • Consent signed and personally dated by patient (or a legally acceptable representative) • Consent signed and dated by person who conducted the informed consent process • 1 copy given to patient, 1 original kept in patient study files, 1 copy in patient medical records

  5. Investigator Responsibilities Ensure that the rights, safety and welfare of the patients in the study are protected by ensuring that the study is conducted according to: • The Protocol • All appropriate regulations

  6. Follow approved protocol and amendments Obtain written informed consent before each patient is entered into the trial Perform all trial procedures in accordance with the protocol Only delegate these functions to authorised personnel Enrol only eligible subjects Investigator must verify that they:

  7. Update on the evidence and on IST-3 progress

  8. Age and time to randomisation 2008 vs. 2009: impact of ECASS-3 ECASS-3 report No. patients recruited per quarter Year, quarter

  9. Does this recent Lancet paper change anything?

  10. Pooled analysis of rt-PA trials Time to treatment and odds of ‘good outcome’ (mRS 0-1) 2004 N=2775 2010 N=3670 Lancet 2004, Lancet 2010

  11. Time to treatment and odds of death: Does trade-off vary with time? Test for interaction p= 0.04 Lancet 2010

  12. Time andodds of symptomatic brain haemorrhage (PH 2) Test for interaction p= 0.4 Lancet 2010

  13. Authors conclusions: • ‘We need to understand better the factors that prevent alteplase from being effective in individual patients… clinical variables e.g.: • age, stroke severity, and comorbidities, • factors pertaining to arterial recanalisation (e.g. clot composition, location, size, and collateral flow) • ‘all must have a role in the success of thrombolysis, but are poorly understood’

  14. Uncertainties about thrombolysis in acute ischaemic stroke: key ist-3 questions • 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) • Fancy imaging: ‘penumbra’, blocked artery? • What is the latest time for net benefit? * Cochrane systematic review Wardlaw et al. BMJ 2009 339; b4584

  15. Ongoing randomised trials iv rt-PA vs control *CT, MR perfusion/angiography optional

  16. IST-3 publicity response! • ‘Opinion piece’ titled ‘Intravenous thrombolysis – where are we now?’ -> International Journal of Stroke. • Podcast on IJS article • Submit IST-3 CT/ MR perfusion & angiography protocol to IJS + podcast • IST-3 newsletter editorial

  17. Recruitment Need 868 more to reach target 27th May n=2232

  18. Recruitment x country

  19. ‘Top ten’ centres with highest average recruitment / month

  20. Centres who randomised patients within last 30 days

  21. The end is in sight!

  22. Recruitment target • 13 months recruitment remain: need 67 patients per month to reach target 3100. • Strategy = • New centres will need to work quickly to become active • Existing centres – what can we do help you increase recruitment? • Other ideas to increase recruitment?

  23. Data quality prize: the Sheila Grant Award! We aim for: • 100% clinical follow up • No missing scans • Queries resolved • Winner: Ospedale DiBranca: 100% complete data! Sheila, our data officer

  24. We have climbed a big mountain – and we are near the top! Not far to go….

  25. Summary • Last patient to be recruited 30.06.2011 • Deadlines • new centres to complete approvals to join: 31/08/10 • new centres must randomise their first patient by 31/12/10 • Final follow-up 31.12.2011 • Main results @ ESC May 2012 • IST-3 is very, very important! • the last large scale trial of thrombolysis versus control, • the only significant-sized trial in older people • The only controlled trial collecting baseline perfusion and angiography data in unselected patients • We are moving on to trials in ICH (PATCH, TRANCHE)

  26. IST-3 will add important new data: • ~2000 outcome events -> will double total RCT weight of evidence • Effects: • in all time windows up to 6h • In ~ 1000 patients aged > 80 years. • in severe and mild stroke: • ~ 300 with NIHSS > 24 (severe), • ~ 600 with NIHSS < 5 (mild) • On long-term survival (to 5 years+) • Value of perfusion/angio data ~ 200 patients

  27. 02230 was randomised 24/05 from Helsingborgs Lasarett Sweden

  28. Centres joined during the past 12 months

  29. www.stroketraining.org

  30. Ongoing RCTs intra-arterial interventional Rx vs iv therapy

  31. What is ICH GCP? • International Conference on Harmonisation Guideline for Good Clinical Practice • Harmonized tripartite guideline to provide a unified standard for the EU, Japan and US to facilitate the mutual acceptance of clinical data by regulatory authorities in these regions • Guidance developed in consideration of current GCP practices in EU, Japan, US, Australia, Canada, Nordic countries & WHO

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