EMIT-AF/VTE
Research type
Research Study
Full title
EMIT-AF/VTE: Edoxaban management in diagnostic and therapeutic procedures
IRAS ID
218345
Contact name
Manish Saxena
Contact email
Sponsor organisation
Daiichi Sankyo Europe GmbH
Clinicaltrials.gov Identifier
NCT02950168, Clinicatrials.gov
Duration of Study in the UK
2 years, 0 months, 31 days
Research summary
This observational prospective registry called “EMIT-AF/VTE: Edoxaban management in diagnostic and therapeutic procedures” is observing patients taking edoxaban (marketed as Lixiana) in a real life setting. Edoxaban is a non-VKA oral anti-coagulant (NOAC) that is prescribed to patients with Atrial Fibrillation (AF) to minimise the risk of stroke or patients with a Venous Thrombosis Event (VTE) to prevent the recurrence of another thrombosis event. The purpose of this registry is to collect data from patients already using edoxaban who undergo a procedure, either for diagnostic or therapeutic reasons (the procedure does not need to be related to the patient’s reason for taking edoxaban). This is of interest as there is currently little data available on how best to manage edoxaban during procedures to best minimise bleeding risk while still maintaining protection from stroke and thrombosis. The registry will collect data on the use of edoxaban before, during and after the procedure, details of the procedure and if the patient has any bleeding or cardiovascular events in the 30 days following the procedure. The patient will sign an Informed Consent Form to consent to their data being collect (either before or shortly after the procedure) and then they will receive a follow up phone call 30 days after the procedure to check on any bleeding or cardiovascular events.
REC name
Wales REC 6
REC reference
17/WA/0071
Date of REC Opinion
6 Mar 2017
REC opinion
Favourable Opinion