Status: Finalised First registered on: 23/11/2016
Last updated on: 17/03/2022
1. Study identification
EU PAS Register NumberEUPAS16014
Official titleCharacterising 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 title acronym
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableEMA/2015/27/PH
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsUtrecht University Pharmacoepidemiology Center
Department/Research groupDivision of Pharmacoepidemiology & Clinical Pharmacology
Organisation/affiliationUtrecht Institute for Pharmaceutical Sciences
Website/Homepagewww.uu.nl/pecp
Details of (Primary) lead investigator
Title Dr
Last name Gardarsdottir
First name Helga
Is this study being carried out with the collaboration of a research network?
Yes
EU PE&PV Research Network
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?6

AU-ADA
Utrecht University Pharmacoepidemiology Center
Pharmacoepidemiology Research Group
Bordeaux PharmacoEpi
FICF
PRC
AEMPS
Countries in which this study is being conducted
International study

Denmark
France
Germany
Netherlands
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/09/201601/09/2016
Start date of data collection01/02/201601/01/2008
Start date of data analysis01/02/2017
Date of interim report, if expected09/02/201812/02/2018
Date of final study report15/06/201805/10/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding schemeEMA tender100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Gardarsdottir
First name Helga
Address line 1Universiteitsweg 99
Address line 2PO Box 80082 
Address line 3 
CityUtrecht 
Postcode3508 TB 
CountryNetherlands
Phone number (incl. country code)31-6-14743867 
Alternative phone number 
Fax number (incl. country code)31-30-2539166 
Email address h.gardarsdottir@uu.nl
Public Enquiries
Title Dr 
Last name Gardarsdottir 
First name Helga 
Address line 1Universiteitsweg 99 
Address line 2PO Box 80082 
Address line 3 
CityUtrecht 
Postcode3508 TB 
CountryNetherlands 
Phone number (incl. country code)31-6-14743867 
Alternative phone number 
Fax number (incl. country code)31-30-2539166 
Email address h.gardarsdottir@uu.nl 
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