1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

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

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

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

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

16. SITS Monitoring Study

17. 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

18. 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 m 6 months years

19. 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: