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

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Collaborators: Hippocrates Research; IMS Health; ITEC Services; Quintiles, Inc.; SSS International Medical Research GmbH
• Treatments: Edoxaban

Criteria

Inclusion Criteria:

• Established acute initial or recurrent VTE

• Patients prescribed treatment with edoxaban according to Summary of Product Characteristics (SmPC) before participation in the trial

• Written informed consent for participation in the study (ICF)

• Not simultaneously participating in any interventional study

Exclusion Criteria:

• None