New outcomes study for ticagrelor (BRILINTA™) to examine longer-term treatment for post- ACS patients

AstraZeneca today announced the initiation of a large, international, clinical outcomes 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. The PEGASUS-TIMI 54 study is scheduled to begin patient enrolment during the fourth quarter 2010.

Current treatment guidelines for acute coronary syndrome (ACS) patients recommend dual antiplatelet therapy for up to twelve months post-event, followed by longer-term treatment with aspirin alone.

The PEGASUS-TIMI 54 study will 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. Such individuals are at substantially increased risk for another cardiovascular event. The 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.

“After a heart attack, patients remain at significant risk of another heart attack or major adverse cardiovascular event. PEGASUS-TIMI 54 will study treatment beyond twelve months after a heart attack, with dual antiplatelet therapy of ticagrelor and aspirin. We are very excited to be addressing this important scientific question,” noted Dr. Marc S. Sabatine, Principal Investigator of the PEGASUS-TIMI 54, Vice Chair of the TIMI Study Group and a Cardiologist at Brigham and Women’s.

PEGASUS-TIMI 54 is a randomised, double-blind, three-arm, parallel-group, international, multi-centre study of approximately 21 000 patients in over thirty countries. The study will be event driven and minimum treatment period is twelve months. Patients will be randomised to either ticagrelor 60 or 90 mg twice daily, or placebo. In addition to ticagrelor or placebo, patients will take once-daily, concomitant aspirin therapy (75 to 150 mg). 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.

“This study represents a further investment in our understanding of ticagrelor and the impact on post- ACS patients over the long term,” said Dr. , Vice President, Clinical Development, AstraZeneca.