Status: OngoingLast updated on: 17/07/2019
1. Study identification
EU PAS Register NumberEUPAS13017
Official titleReal-life anticoagulants comparative benefit-risk in nonvalvular atrial fibrillation (NVAF) in France
Study title acronymENGEL 2
Study typeOther: Study using the French health insurance and hospital-discharge database
Brief description of the studyThe research question is to compare the 1-year and long-term benefit-risk between each of direct oral anticoagulant (DOAC) (Pradaxa®, Xarelto®) vs vitamin K (VKA) for new users in nonvalvular atrial fibrillation (NVAF). The main objective is to compare the 1-year risk of major bleeding, stroke and systemic embolism (SSE) (prior named “arterial thrombotic events” as in the protocol and the study report “One-year of follow-up”), myocardial infarction (MI) and death for each DOAC (dabigatran, rivaroxaban) vs VKA in NVAF during drug exposure. The secondary objectives are to compare healthcare resources use and their related costs during drug exposure on the 1-year of follow-up, and the long-term risk (2 and 3-year) of the same outcomes for each DOAC vs VKA and for dabigatran vs rivaroxaban according to the initial DOAC doses. This is a cohort study in the French natiowide claims database including new users of DOAC or VKA in NVAF in 2013 with a follow-up until 31 December 2016, and 3 years history. The index date will be that of the first dispensing of DOAC or VKA in 2013. Data will be extracted from 2010 to 2016. Outcomes analysis will be performed during drug exposure for matched patients on high-dimensional propensity score (hdPS), and all patients with hdPS adjustment.
Was this study requested by a regulator?Yes: France
Is the study required by a Risk Management Plan (RMP)? Not applicable
Other study registration identification numbers and URLs as applicableClinicalTrial.gov: NCT02785354
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Professor
Last name Moore
First name Nicholas
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed19/12/2014
Start date of data collection05/04/2016
Start date of data analysis25/04/2016
Date of interim report, if expected25/10/2018
Date of final study report31/10/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBoehringer Ingelheim France100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Blin
First name Patrick
Address line 1146 Rue Leo Saignat
Address line 2 
Address line 3 
CityBordeaux 
Postcode 
CountryFrance
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name Blin 
First name Patrick 
Address line 1146 Rue Leo Saignat 
Address line 2 
Address line 3 
CityBordeaux 
Postcode 
CountryFrance 
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code) 
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