Officials at AstraZeneca have released the top-line results from its Socrates trial, which was designed to determine the efficiency of Brilinta/Brilique (tricagrelor) 90-milligram tablets administered twice daily.
Brilinta efficacy was compared to aspirin at 100 milligrams administered once a day. The targeted patients have acute ischaemic stroke or else transient ischaemic attack (TIA).
The results indicate that the product missed its primary efficiency endpoint. There were fewer events that were seen with Brilinta, but this trend has not shown a statistical significance.
Strokes are the second leading cause of death around the world. An estimated 16.9 million people experienced their first strokes in 2010 alone. In the same year, approximately 5.9 million people died from stroke-related incidents. People with acute ischemic stroke or TIA have a higher chance of developing resulting ischemic events, especially within the first 90 days of the index event.
“We will present the full analysis of the trial results, including subgroups, at a forthcoming stroke congress and will engage with regulatory agencies on the interpretation of the data,” Sean Bohen, chief medical officer at AstraZeneca, said. “The Socrates trial enrolled a patient population that differs from the currently-approved indications for Brilinta/Brilique.”