Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46296
• EU PAS number:
  EUPAS16014
• Study ID:
  46296
• Official title and acronym:
  Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  France

  Germany

  Netherlands

  Spain
• Study description:
  This study is using longitudinal data collected in 8 electronic health care databases from six EU countries to characterize the risk of major bleeding in Direct Oral Anticoagulant (DOAC) users in a real-world setting to help establish the effectiveness of existing and future risk minimization measures. The research undertaken will focus on targeted clinical and demographic subgroups for which variations in plasma concentrations might affect the safety of the products.
• Study status:
  Finalised

Research institution and networks

Institutions

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

Fundació Institut Català de Farmacologia (FICF)

Spain

Pharmacoepidemiology Research Collaboration (PRC), University of Copenhagen

Denmark

Aarhus University

Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency for Medicines and Medical Devices, AEMPS)

Spain

Networks

EU Pharmacoepidemiology and Pharmacovigilance (PE&PV) Research Network

Netherlands

Study timelines

Date when funding contract was signed

Actual: 01/09/2016

Study start date

Actual: 01/01/2008

Date of interim report, if expected

Actual: 12/02/2018

Date of final study report

Actual: 05/10/2018

Study protocol

Initial protocol

20161101_DOAC_bleedingProtocol_Forreview

Updated protocol

20180601_AMENDED_PROTOCOL_DOAC_bleeding_EUPAS16014_version 3.0

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

EMA/2015/27/PH