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 (BRILINTATM/BRILIQUETM) 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. Jonathan Fox, Vice President, Clinical Development, AstraZeneca.
About Ticagrelor (BRILINTATM/BRILIQUETM)
Ticagrelor is an oral antiplatelet treatment for ACS. Ticagrelor is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). Ticagrelor is the first reversibly-binding oral ADP receptor antagonist.
In the phase III, PLATO (A Study of Platelet Inhibition and Patient Outcomes) study, ticagrelor achieved greater efficacy over clopidogrel in reducing cardiovascular events, including CV death, heart attacks (myocardial infarction) and stroke, without an increase in major bleeding.
Ticagrelor is currently under regulatory review in twelve territories around the world. BRILINTA and BRILIQUE are trademarks of the AstraZeneca group of companies.
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit: www.astrazeneca.com
About the Thrombolysis in Myocardial Infarction (TIMI) Study Group
Since its inception in 1984 the principal goal of the TIMI Study Group has been to conduct high quality clinical trials that enhance the care of patients with coronary artery disease. TIMI has been involved in a wide array of phase 1 to phase 4 trials as well as registries. These have ranged in size from less than 30 to more than 300,000 subjects. The interventions studied include fibrinolytic, antithrombotic, anti-platelet, anti-ischemic and lipid lowering agents as well as percutaneous coronary intervention. In addition, the TIMI Study Group has used its growing database of clinical findings, biomarkers, and genetic tests to enhance the understanding of coronary artery disease. An important corollary goal has been to train the next generation of clinical investigators. TIMI is especially proud of those trainees who have assumed leadership positions in leading institutions around the world.