Non-interventional study on Edoxaban treatment in routine clinical practice in patients with venous thromboembolism

Study identification

• EU PAS number:
  EUPAS15504
• Study ID:
  18098
• Official title and acronym:
  Non-interventional study on Edoxaban treatment in routine clinical practice in patients with venous thromboembolism
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Germany

  Ireland

  Italy

  Netherlands

  Switzerland

  United Kingdom
• Study description:
  Edoxaban is an orally administered anticoagulant that inhibits coagulation factor Xa. It has been recently approved by the European Medical Agency (EMA) 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 (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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Guy's and St Thomas' NHS Foundation Trust

Study timelines

Date when funding contract was signed

Actual:12/12/2014

Study start date

Planned:01/02/2017

Actual:22/12/2016

Data analysis start date

Planned:01/02/2021

Date of final study report

Planned:15/09/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Daiichi-Sankyo-Europe

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)