Non-interventional study on Edoxaban treatment in routine clinical practice for patients with non valvular atrial fibrillation (ETNA-AF-Europe)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20482
• EU PAS number:
  EUPAS8896
• Study ID:
  20482
• Official title and acronym:
  Non-interventional study on Edoxaban treatment in routine clinical practice for patients with non valvular atrial fibrillation (ETNA-AF-Europe)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  France

  Germany

  Ireland

  Italy

  Luxembourg

  Netherlands

  Portugal

  Spain

  Switzerland

  United Kingdom
• Study description:
  Edoxaban has recently been approved by the European Medicines Agency EMA for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors, as well as for the treatment of adult patients with venous thromboembolism and the prevention of recurrent venous thromboembolism. In order to understand the risks and benefits of Edoxaban use in a real-world clinical setting, Daiichi-Sankyo proposed this post-authorization safety study (PASS) to gain insight into the safety (bleeding, liver adverse events, and other drug related adverse events) of Edoxaban use in non-preselected patients with non-valvular atrial fibrillation (NVAF).Real world evidence data of routine clinical practice use of Edoxaban up to 4 years will be collected in 13100 patients, treated by specialized as well as non-specialized physicians in hospitals and office based centres.
• Study status:
  Ongoing

Research institution and networks

Institutions

University of Birmingham

School of Clinical and Experimental Medicine

The total number of planned centres is 1500. Europe

Study timelines

Date when funding contract was signed

Planned: 30/11/2014

Actual: 30/11/2014

Study start date

Planned: 01/08/2015

Actual: 14/08/2015

Data analysis start date

Planned: 01/10/2021

Date of interim report, if expected

Planned: 01/04/2019

Date of final study report

Planned: 31/12/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Daiichi Sankyo Europe GmbH

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)