NCT02943993

Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe

Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,809 (actual)
• Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Real-world evidence data in routine clinical practice use of edoxaban up to 18 months will be collected in 2,700 patients, treated by specialized as well as non-specialized physicians in hospitals and office based centres in 8 European countries. Patients from different countries and care settings (primary care and secondary care, different specialties) will be enrolled in this post-authorization safety study. Documentation of baseline and follow up information at 1, 3, 6, 12, and 18 months (only when available) will be collected. In addition, recurrence of symptomatic VTE and death will be captured retrospectively at time point of Last Patient Out per country. Patients who discontinue permanently edoxaban during the observational period will be followed up according to the same scheme.

Conditions

• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	Edoxaban	Prescribed according to approved label

Timeline

• Start date: 2016-04-06
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2016-10-25
• Last updated: 2025-04-01
• Results posted: 2022-05-02

Locations

1 site across 1 country: Germany