It was conducted in collaboration with the Thrombolysis in Myocardial Infarction (TIMI) Study Group from Brigham and Women’s Hospital (Boston, MA, USA). PEGASUS-TIMI 54 (PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk Patients with Prior AcUte Coronary Syndrome – Thrombolysis In Myocardial Infarction Study Group) is one of AstraZeneca’s largest ever outcomes trials with more than 21,000 patients from over 1,100 sites in 31 countries in Europe, the Americas, Africa and Australia/Asia. Design and rationale for the Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin–Thrombolysis in Myocardial Infarction 54 (PEGASUS-TIMI 54) trial. ![]() NOTES TO EDITORSġ Bonaca MP, Bhatt DL, Braunwald E, et al. 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. The PLATO study, involving over 18,000 patients, was the first study in the programme and is the basis on which ticagrelor has been approved in over 100 countries and included in 12 major ACS treatment guidelines globally. The PEGASUS-TIMI 54 study is part of AstraZeneca’s PARTHENON programme. Ticagrelor is not approved for secondary prevention of atherothrombotic events in patients with a history of heart attack beyond one year. 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.Ĭomplete 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. 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 1. We look forward to presenting the data later this year.” The results build on existing understanding of the benefits of BRILINTA for patients with acute coronary syndrome and offer important clinical insights into its potential role for the longer term prevention of cardiovascular events. Full evaluation of the data is ongoing.Įlisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, AstraZeneca, said: “We are very pleased with the top line results of the PEGASUS-TIMI 54 study, the second positive major outcomes study in the PARTHENON programme. Preliminary analysis did not reveal any unexpected safety issues. The primary efficacy endpoint was a composite of cardiovascular (CV) death, myocardial infarction (MI) or stroke. The study assessed BRILINTA® (ticagrelor) tablets at either 60mg twice daily or 90mg twice daily plus low-dose aspirin for the secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study start. ![]() Both BRILINTA 60mg and 90mg demonstrate statistically significant reduction in major cardiovascular thrombotic events in patients with a history of heart attackĪstraZeneca today announced that the PEGASUS-TIMI 54 study, a large scale outcomes trial involving over 21,000 patients, successfully met its primary efficacy endpoint.
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