TROICA (Thrombolysis in Cardiac Arrest) is a randomized, double-blind, placebo-controlled Phase III clinical study of a single-bolus fibrinolytic (tenecteplase) to assess the efficacy and safety of pre-hospital fibrinolytic therapy in cardiac arrest of presumed cardiac origin. The primary endpoint of the trial is 30-day survival rate and the co-primary endpoint is survival to hospital admission.

TROICA is a multicentre trial that was planned and implemented under the aegis of the ERC with an Executive Committee and Steering Committee that has strong ERC participation reporting to the Council’s Research Committee under its Chairmen Professor Johan Herlitz and Professor Bernd Boettiger, who is also Chairman of the TROICA Executive and Steering Committees. The funding and day-to-day administration of the trial is in the hands of Boehringer Ingelheim International.

Patient enrolment was suspended after a meeting of the Executive and Steering Committees on 23 March 2006. This suspension followed the recommendation of the independent Data Safety Monitoring Board (DSMB) that was issued as a result of a planned interim data review.

A preliminary data analysis has shown that the probability the study will demonstrate overall superiority of tenecteplase over placebo is low. The study was not suspended for safety reasons: importantly, the intracranial haemorrhage rate is within the expected range for fibrinolytic treatment.

The suspension will remain at least until further analysis of the data has been undertaken, after which further decisions will be made.

3 April 2006

Prof. Douglas Chamberlain
Prof. Bernd Boettiger