AEGEAN (Assessment of an Education and Guidance programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation)
Project Objectives
A multicenter randomized study on evaluation of the impact of an educational program on patient adherence in patients taking Eliquis.
Primary Outcome Measures:
Percentage of days with a correct execution of the Apixaban dosing regimen during 24 weeks.
This endpoint will be compared between the two study groups: Standard of care (SOC) information or additional education
Secondary Outcome Measures:
- Within each study group, percentage of days with a correct execution of the Apixaban dosing regimen during the 12 to 24 weeks period compared with during the first 12 weeks
- Adherence to Apixaban dosing regimen during the 24 to 48 weeks in continued additional education group, secondary SOC group, and primary SOC group
- Risk factors indicative of non-adherence at 24 and 48
- Incidence of serious adverse events (AEs) and other AEs, including major bleeding (ISTH)
Start and End Dates
November 2014 - November 2015
Principal Investigator
- Dr. Giuseppe Patti – Local Principal Investigator
- Prof. Germano Di Sciascio
Host Institution
Campus Bio-Medico University of Rome
Other Institutions involved
Bristol-Meyers Squibb Company
