Ticagrelor meets primary efficacy endpoint in secondary prevention outcomes trial
The PEGASUS-TIMI 54 outcomes trial evaluating the use of the P2Y12 receptor antagonis ticagrelor plus low-dose aspirin for the secondary prevention of atherothrombotic events has met its primary efficacy endpoint. Both oral doses of 60 mg twice daily and 90 mg twice daily were assessed, in over 21.000 patients who had experienced a heart attack one to three years prior to study start. The primary endpoint was a composite of cardiovascular (CV) death, myocardial infarction (MI) or stroke.
The PEGASUS-TIMI 54 study investigated two different doses of ticagrelor on a background of low dose aspirin versus placebo plus low dose aspirin, in patients aged 50 and older with a history of heart attack and one additional CV risk factor. The study was designed to better understand the management of patients more than 12 months after their heart attack, who remain at high risk for major thrombotic events.
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.
The PEGASUS-TIMI 54 study is part of the PARTHENON programme. Further ongoing PARTHENON studies are assessing ticagrelor for the prevention of cardiovascular events in patients with peripheral arterial disease, ischaemic stroke or transient ischaemic attack, and in patients with diabetes and coronary atherosclerosis.