Boehringer Ingelheim terminates phase III clinical trial

Boehringer Ingelheim has announced it has cancelled a phase III clinical trial to assess the efficacy and safety of Metalyse, a thrombolytic drug, as a pre-hospital thrombolytic therapy in patients outside the hospital with cardiac arrest of presumed cardiac origin.

Thrombolytic drugs are commonly known as “clot-busters” and the trial for Metalyse, entitled TROICA, was used to test the effectiveness of the drug in out-of-hospital cardiac arrest patients who showed no signs of restoration of spontaneous circulation.

The trial had enrolled 1,050 of the planned 1,300 patients, with primary endpoints of the patient being admitted to hospital for intensive care or cardiac care treatment and achieving a 30-day survival rate. However, enrolment in the trial was halted in March after a preliminary data analysis showed that the likelihood the study would demonstrate Metalyse’s superiority over the placebo would be “very low”.

After the recommendation of an independent data safety monitoring board, the trial was cancelled two weeks ago.

A statement from Boehringer Ingelheim read: “The study was not suspended for safety reasons. Early animal and human data suggesting that lytic therapy might prove beneficial had provided the rationale for this exploratory trial.”

“The decision to terminate the TROICA trial has no implication on the registered indication of Metalyse for ST elevation acute myocardial infarction,” the statement concluded.

Metalyse was approved by the European Commission in 2001 to treat acute myocardial infarction – the first thrombolytic drug that can be administered over five seconds in a single bolus dose in the treatment of a heart attack, Boehringer Ingelheim states.

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