Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe
Status:
Completed
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
According to current guidelines, duration of anticoagulant treatment after a venous
thromboembolic event varies from 3 months to indefinite treatment depending on the estimated
risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are
limited to a maximum treatment duration of 12 months (Hokusai-VTE; N Engl J Med. 2013;
369:1406-15).
Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic
recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality
and other drug related adverse events) of extended treatment with edoxaban up to 18 months in
an unselected patient population in routine clinical practice.
Details
Lead Sponsor:
Daiichi Sankyo Inc. Daiichi Sankyo, Inc.
Collaborators:
Hippocrates Research IMS Health ITEC Services Quintiles, Inc. SSS International Medical Research GmbH