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news.AstraZeneca has released complete results from a large-scale outcomes PEGASUS-TIMI 54 trial of BRILINTA (ticagrelor) tablets for the chronic secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study enrolment.
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The study was designed to investigate the effect of adding ticagrelor at 60mg and 90mg to low dose aspirin on reducing the risk of CV death, heart attack or stroke in patients aged 50 and older with a history of heart attack and one additional CV risk factor.
The trial evaluated BRILINTA tablets plus low dose aspirin, compared to placebo plus low dose aspirin in these patients.
The data showed that both 90mg and 60mg doses of ticagrelor with aspirin significantly reduced the primary composite endpoint of cardiovascular (CV) death, myocardial infarction (MI) or stroke compared to placebo.
AstraZeneca vice president,hHead of Cardiovascular and Metabolic Diseases, Global Medicines Development Elisabeth Björk said: "As a company we are committed to furthering cardiovascular research and are proud to have delivered the PEGASUS-TIMI 54 study, AstraZeneca's largest clinical trial, involving more than 21,000 patients worldwide.
"Building on the landmark PLATO trial in acute coronary syndrome, the positive PEGASUS study adds to the body of evidence for BRILINTA and is the first prospective trial to evaluate longer term dual antiplatelet therapy in higher risk patients with a history of a heart attack.
"We have just submitted regulatory filings to the European Medicines Agency and the US Food and Drug Administration and we look forward to working with these agencies towards a potential new indication in major markets."
Consistent with studies in similar patient populations, TIMI Major Bleeding, the trial's primary safety endpoint, was higher with both doses of ticagrelor plus aspirin compared to placebo plus aspirin.
The company also said that significantly, the rates of intracranial haemorrhage and fatal bleeding were low and were similar between study groups and the placebo arm.