The GLOBAL LEADERS trial is an Investigator-Sponsored Study (ISS) in which 16,000 “all-comer” patients are enrolled in 131 centers in 18 countries in Europe, Australia, Brazil, Canada & Singapore. Patients treated with bivalirudin (in countries where available) and a Biomatrix stent have been randomized either to ticagrelor plus aspirin, followed by 1 month of ticagrelor monotherapy for 23 months, or intensive dual antiplatelet therapy for 24 months.
The first patient in the GLOBAL LEADERS trial was enrolled by Dr. Aminian from the CHU in Charleroi, Belgium.
The Principal Investigators are Stephan Windecker (Switzerland), Marco Valgimigli (Italy), and Pascal Vranckx (Belgium). Patrick Serruys (the Netherlands) is the study Chairman. GLOBAL LEADERS is being run by the European Cardiovascular Research Institute, ECRI (http://clinicaltrials.gov/show/NCT01813435). ECRI is being supported by scientific grants from Biosensors, AstraZeneca, and The Medicines Company.
In this important trial, Cardialysis is responsible for project management, data management, site monitoring, the Data Safety and Monitoring Board, and safety reporting.