SITS%20Monitoring%20Study%20SITS-MOST

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SITS Monitoring StudySITS-MOST

• Safe Implementation of Thrombolysis in Stroke
  SITS Collaboration
• Nils Gunnar Wahlgren, Antoni Davalos, Martin
  Grond, Cesare Fieschi, Werner Hacke, Markku
  Kaste, Rüdiger von Kummer, Vincent Larrue,
  Kennedy R Lees, Joanna Wardlaw for the SITS
  collaborators

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What is SITS?

• SITS is
• an international network of medical professionals
  dedicated to safe implementation of thrombolysis
  treatment in acute stroke
• Started as an initiative by ECASS investigators

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What is SITS International Stroke Thrombolysis
Register (SITS-ISTR)?

• SITS-ISTR is
• an internet-based, on-line data entry, immediate
  feed back reporting, ongoing audit of
  thrombolysis in acute stroke
• It has national coordinators in almost all EU
  countries and beyond
• It is running, around 200 patients included

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What is SITS-MOST?

• SITS-MOST is
• a study built on the SITS-ISTR
• aims to include gt1000 patients treated lt 3 hrs
• defined inclusion criteria
• qualified centres, with or without experience
  from thrombolysis in stroke

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SITS-MOST rationale

• Systematic reviews of randomised controlled
  trials indicate rt-PA is highly beneficial lt 3h
  after stroke
• Karolinska Stroke Update Consensus Statement on
  thrombolysis treatment recommend rt-PA lt 3 h
  after stroke onset provided monitoring is
  performed
• Conditional license of Actilyse lt 3h expected in
  Europe

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Suggested role of SITS-MOST and 3-4 h RCT after
licencing of Actilyse for acute stroke
gt 4,5 tim
lt 3 h SITS-MOST
3-4 h RCT
All Studies
ECASS 2
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SITS-MOST is an observational study comparing
outcome with a systematic review of randomised
controlled trials
No placebo arm
SITS-MOST active rt-PA treatment
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SITS-MOST is an observational study comparing
outcome with a systematic review of randomised
controlled trials
No placebo arm
SITS-MOST active rt-PA treatment
Active rt-PA arm in RCT/review
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SITS-MOST is an observational study comparing
outcome with a systematic review of randomised
controlled trials
No placebo arm
SITS-MOST active rt-PA treatment
Active rt-PA arm in RCT/review
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SITS-MOST Aim

• To prove that rt-PA is at least as safe and as
  beneficial in clinical routine as in randomised
  controlled trials when the treatment is being
  implemented broadly to the European population in
  experienced as well as less experiences centres

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SITS-MOST secondary aims

• SICH, mortality and independence relaterad to
  background variables
• Independence compared with expected outcome in
  prognostic model based on placeo arm i RCT
• Risk model for haemorrhage and death
• Outcome in stroke subgroups
• And others

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Main observational variables

• Symptomatic intracranial haemorrhage (SICH) /
  Parenchymatous haemorrhage (PH2)
• Death
• Independence (mRS 0-2)

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What are the proportions of the SITS-MOST
primary observation variables in randomised
controlled trials systematic review
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How many patients are required in SITS-MOST for
comparisons?
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What are the proportions of the SITS-MOST
primary observation variables in randomised
controlled trials systematic review
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SITS Monitoring Study
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SITS-MOST independent follow up

• Haemorrhage evaluated by BRIC (Brain Imaging
  Committee, von Kummer/Wardlaw, coordinated by
  Hårdemark)
• Mortality, independence - follow up by National
  Coordinating centre in each country

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What and when?
RCT 3-4 hours (outwith SPC)
SITS-MOST (within SPC)
No approval of treatment outwith SITS-MOST
OK 3 m 6 months 3 years
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Open meeting in Geneva

• An open meeting will take place immediately after
  ESC in Geneva
• Saturday 1st June 2002, 14-17, Room 2
• SITS website
• www.acutestroke.org

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