Boehringer Ingelheim has begun patient enrolment into TROICA, a randomized, double-blind, placebo-controlled Phase III clinical study of the single-bolus thrombolytic Metalyse (tenecteplase) to assess the efficacy and safety of pre-hospital thrombolytic therapy in cardiac arrest of presumed cardiac origin, was suspended pending further blinded analysis of the study data.
A preliminary data analysis showed that the probability the study will demonstrate superiority of tenecteplase over placebo is very low. The study was not suspended for safety reasons since the intracranial hemorrhage rate is within the expected range for fibrinolytic treatment.
Enrolment has been suspended until further analysis of the data is complete. Further decisions about the TROICA study are pending until the additional analysis is finalized.