Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe
NCT02943993 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2809
Last updated 2025-04-01
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.
Conditions
- Venous Thromboembolism
Interventions
- DRUG
-
Edoxaban
Prescribed according to approved label
Sponsors & Collaborators
-
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
lead INDUSTRY
Principal Investigators
-
Global Clinical Leader · Daiichi Sankyo
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-04-06
- Primary Completion
- 2020-12-01
- Completion
- 2020-12-01
Countries
- Germany
Study Locations
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