SITS Monitoring Study SITS-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

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

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

What is SITS-MOST? SITS-MOST is: a study built on the SITS-ISTR aims to include >1000 patients treated < 3 hrs defined inclusion criteria qualified centres, with or without experience from thrombolysis in stroke

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

Suggested role of SITS-MOST and 3-4 h RCT after licencing of Actilyse for acute stroke > 4,5 tim < 3 h SITS-MOST 3-4 h RCT All Studies ECASS 2

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

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

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

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

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

Main observational variables: Symptomatic intracranial haemorrhage (SICH) / Parenchymatous haemorrhage (PH2) Death Independence (mRS 0-2)

What are the proportions of the SITS-MOST primary observation variables in randomised controlled trials – systematic review

How many patients are required in SITS-MOST for comparisons?

What are the proportions of the SITS-MOST primary observation variables in randomised controlled trials – systematic review

SITS Monitoring Study

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

RCT 3-4 hours (outwith SPC) SITS-MOST (within SPC) 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

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