Boehringer Ingelheim suspend enrolment into phase III study of Metalyse® treating out of hospital cardiac arrest of presumed cardiac origin
Interim data review shows lack of benefit over placebo
Ingelheim/Germany, 28 March 2006 - Boehringer Ingelheim confirmed today that 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 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 into this trial 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.
About the Study
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 (= as soon as possible after insertion of the IV line) 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 the first “clot-buster” that can be administered over five seconds in a single dose in the treatment of heart attack. 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 (the letters T, N and K represent the three regions changed from the natural t-PA protein).
All thrombolytic agents increase 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.
About Cardiac Arrest
Sudden cardiac arrest is a sudden, complete loss of heart function in which little or no blood is being pumped to the rest of the body. Most episodes are caused by the rapid and/ or chaotic activity of the heart known as ventricular tachycardia or fibrillation. Acute myocardial infarction and massive pulmonary embolism are the underlying causes of out-of-hospital cardiac arrest in 50-70% of patients. Unexpected cardiac arrest continues to be an important cause of death in the industrialised world. Unfortunately only a small proportion of out-of-hospital sudden cardiac arrest (SCA) patients survive to hospital discharge.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 144 affiliates in 45 countries and nearly 36,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. In 2004, Boehringer Ingelheim posted net sales of 8.2 billion euro while spending nearly one fifth of net sales in its largest business segment Prescription Medicines on research and development.
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