ETNA-VTE-Europe

• Research type

  Research Study

• Full title

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

• IRAS ID

  184797

• Contact name

  Alexander Cohen

• Contact email

  alexander.cohen@kcl.ac.uk

• Duration of Study in the UK

  3 years, 5 months, 1 days

• Research summary

  Edoxaban is an orally administered anticoagulant that inhibits coagulation factor Xa. It is currently approved for use in adult patients for the treatment of acute venous thromboembolism (VTE) including deep vein thrombosis (DVT) and/or pulmonary embolism (PE), and prevention of recurrent VTE in adults.

  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. Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events and other drug related adverse events) of extended treatment with edoxaban up to 18 months in an unselected patient population in routine clinical practice.

• REC name

  West of Scotland REC 5

• REC reference

  15/WS/0170

• Date of REC Opinion

  26 Aug 2015

• REC opinion

  Favourable Opinion