Status: Finalised First registered on: 23/05/2014
Last updated on: 17/11/2020
1. Study identification
EU PAS Register NumberEUPAS6616
Official titleReal-life anticoagulants benefit-risk in atrial fibrillation (AF) in France: VKA benefit-risk assessment before DOAC use for AF
Study title acronymENGEL 1 VKA
Study typeOther: Study using the French health insurance and hospital-discharge database
Brief description of the studyThe research question is to assess the baseline short-term, medium-term and long-term benefit-risk of vitamin K antagonists (VKA) for new users in the indication of atrial fibrillation (AF). The main objective is to estimate the 6-month, 1-year, and 3-year risk of major bleeding, arterial thrombotic events (stroke, systemic embolism), myocardial infarction (MI) and death during VKA exposure. This is a cohort study in a national healthcare claims and hospitalisations database including new users of VKA for AF between 01/01/2007 and 31/12/2011 with a follow-up until 31/12/2012, and 2 years history. VKA exposure will start at the date of first VKA dispensation (index date) and end at the date of VKA stop or at the end of follow-up. AF population will be defined as patients with full coverage for AF, hospitalisation or probabilistic AF information in the database, and without other probable cause of VKA prescription. Outcomes will be defined by primary diagnosis ICD-10 codes of hospital-discharge summary and date of death. The cumulative incidence of outcomes will be estimated using Kaplan-Meier estimate and 95% confidence interval.
Was this study requested by a regulator?No
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 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.bordeauxpharmacoepi.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 signed23/05/2014
Start date of data collection15/04/2014
Start date of data analysis
Date of interim report, if expected
Date of final study report14/11/2014
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