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.

This suspension followed the recommendation of an independent Data Safety Monitoring Board ( DSMB ) during a planned interim data review.

A preliminary data analysis showed that the probability the study will demonstrate superiority of Tenecteplase over placebo was very low.

The TROICA ( Thrombolysis in Cardiac Arrest ) study enrolled patients suffering from out-of-hospital cardiac arrest of presumed cardiac origin and without restoration of spontaneous circulation ( ROSC ).
The patients received Tenecteplase or matching placebo immediately after randomization and after first vasopressor injection within the standardized advanced cardiac life support ( ACLS ) and cardio pulmonary resuscitation-( CPR ) procedures.
These procedures were continued until the patients arrive at a cardiac or intensive care unit.

The primary endpoint of the trial was the 30-day survival rate and the co-primary endpoint was hospital admission. At the time the trial was suspended, approximately 1,000 of the 1,300 planned patients were enrolled.

Tenecteplase is a single-bolus thrombolytic agent approved by the European Commission in February 2001 for the treatment of acute myocardial infarction ( AMI ).
Tenecteplase is a bioengineered variant of Actilyse ( Alteplase, recombinant ), which is a recombinant DNA-derived version of naturally occurring tissue plasminogen activator ( t-PA).
It is constructed with amino acid substitutions at three sites.

Tenecteplase increases the risk of bleeding, including intracranial bleeding, and should be used only in eligible patients. In addition, thrombolytic therapy increases the risk of stroke, including hemorrhagic stroke, in elderly patients.

Source: Boehringer Ingelheim, 2006


XagenaMedicine2006