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news.AstraZeneca has started an international, clinical outcomes Pegasus-TIMI 54 study for the investigational oral antiplatelet, ticagrelor (Brilinta/Brilique) in collaboration with the Brigham and Women’s Hospital-based thrombolysis in myocardial infarction (TIMI) study group.
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The Pegasus-TIMI 54 study aims to determine in this group of patients if treatment with ticagrelor and aspirin will further reduce the risk of subsequent cardiovascular events compared to aspirin alone.
Brigham and Women’s cardiologist and TIMI Study Group vice chair and Pegasus-TIMI 54 principal investigator Marc Sabatine said that Pegasus-TIMI 54 would study treatment beyond 12 months after a heart attack, with dual antiplatelet therapy of ticagrelor and aspirin.
Pegasus-TIMI 54 is a randomised, double-blind, three-arm, parallel-group, international, multi-centre study which is expected to examine the long-term efficacy and safety of ticagrelor in patients who have sustained a heart attack from one to three years prior to enrolment.
In the Pegasus-TIMI 54 study patients will be randomised to either ticagrelor 60 or 90mg twice daily, or placebo and additionally, patients will also take once-daily, concomitant aspirin therapy (75 to 150mg).
The primary efficacy endpoint for the Pegasus-TIMI 54 study will be time to first occurrence of any cardiovascular event including CV death, non-fatal myocardial infarction or non-fatal stroke.
AstraZeneca said that the Pegasus-TIMI 54 study is scheduled to begin patient enrolment during the fourth quarter 2010.