Trial of Brilinta in ACS meets primary endpoint-AstraZeneca
AstraZeneca announced that the PEGASUS-TIMI 54 study, which assessed Brilinta (ticagrelor) plus low-dose aspirin for the secondary prevention of atherothrombotic events successfully met its primary efficacy endpoint. The study involved giving tablets at either 60mg twice daily or 90mg twice daily plus low-dose aspirin for the secondary prevention of atherothrombotic events in over 21000 Acute Coronary Syndrome patients who had experienced a heart attack one to three years prior to study start.
The primary efficacy endpoint was a composite of cardiovascular (CV) death, myocardial infarction (MI) or stroke. Preliminary analysis did not reveal any unexpected safety issues. Full evaluation of the data is ongoing. Complete results from the PEGASUS-TIMI 54 study will be submitted to a scientific meeting in 2015 and pending further analysis, AstraZeneca plans to file this data with regulatory health authorities. Ticagrelor is not approved for secondary prevention of atherothrombotic events in patients with a history of heart attack beyond one year.