Status: PlannedLast updated on: 23/05/2014
1. Study identification
EU PAS Register NumberEUPAS6616
Official titleREal-life aNticoaGulants bEnefit-risk in atrial fibrilLation in France
Study title acronymENGEL 1a
Study typeOther: Study using the national health insurance and hospital-discharge database
Brief description of the studyThe research question is to estimate the baseline short-term, medium-term and long-term risk and benefit of vitamin K antagonists (VKA) for new users in the indication of atrial fibrillation (AF) and for those with the same characteristics as new users of new oral anticoagulants (NOAC) for AF during the second half of 2012. The main objective is to estimate the 3-month, 1-year, and 3-year risk of major bleeding, risk of arterial thrombotic events (stroke, systemic embolism), risk of MI and risk of death during VKA exposure for new users in the indication of AF and for those with the same characteristics as new users of NOAC for AF during the second half of 2012 (NOAC-like VKA population). The study is a cohort study in a national healthcare claims and hospitalisations database with a main cohort including new users of VKA for AF between 01/01/2006 and 31/12/2011 (VKA cohort) and a sub-cohort corresponding to a sample of the VKA cohort with patients having the same characteristics as the NOAC (NOAC-like VKA cohort). Main criteria for inclusion in VKA cohort will be: first reimbursement of VKA in the database between 01/01/2006 and 31/12/2011, at least two years database history before, and at least one year up to three years of follow-up in the database after. Exposures will be defined by claims for drug dispensation during follow-up, and outcomes by primary diagnosis ICD-10 codes of hospital-discharge summary and date of death. The study period is defined by the years 2004 to 2012. The AF prevalence is estimated between 510 000 and 1 020 000 subjects. About 1% of these subjects should be included in the EGB.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Other study registration identification numbers and URLs as applicable
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 signed01/04/2014
Start date of data collection15/04/2014
Start date of data analysis
Date of interim report, if expected
Date of final study report31/10/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBoehringer Ingelheim100
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) 
Top