AEGEAN study CV185220 v3.0 23 Jan 2013
Research type
Research Study
Full title
Assessment of an Education and Guidance programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN)
IRAS ID
131430
Contact name
Gregory Lip
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2013-000055-41
Research summary
In this study, we have developed some additional ways to help people understand better how to take their medicine in the correct way and in keeping with the recommended instructions. We call this the ‘additional educational programme’.
The purpose of this study is to assess the effect of the ‘additional educational programme’ on patient to medication adherence. This will be compared to the ‘standard of care’ information. The study is only examining adherence in patients who have atrial fibrillation (an irregular heart rhythm).
Overall there will be about 1000 patients across 8 countries in Europe. In the UK we expect to include about 80-100 of these patients.
Patients will receive apixaban (Eliquis) 5 mg (or 2.5 mg) twice a day and will be randomly assigned by chance (similar to the toss of a coin) to receive either the additional educational programme or usual standard care. They have an equal 50/50 chance of being assigned to the additional educational programme or usual standard care.
Participants will have 7 planned visits (including screening visit) as part of the study over the 48 week period.
The overall study objective is to assess the impact of educational programme on patient adherence in patients taking apixaban for stroke prevention in atrial fibrillation at 24 weeks. Then the study will look at an additional educational programme for an extra 24 weeks following the first 6 months of the study.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0858
Date of REC Opinion
13 Jan 2014
REC opinion
Further Information Favourable Opinion