Status: FinalisedLast updated on: 20/09/2019
1. Study identification
EU PAS Register NumberEUPAS14567
Official titleBenefit-risk of arterial thrombotic prevention with rivaroxaban for atrial fibrillation in daily clinical practice
Study title acronymBROTHER
Study typeOther: Study using the French health insurance and hospital-discharge database
Brief description of the studyThe research question is to assess the one-year and two-year benefit-risk of rivaroxaban for stroke prevention in atrial fibrillation (SPAF) compared to vitamin K antagonists (VKA) and dabigatran among new anticoagulant users. The main objective is to compare the one-year and two-year risk of the following individual outcomes: stroke and systemic embolism (SSE), major bleeding and death, between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran (standard and reduced doses). Secondary outcomes were clinically relevant bleeding (CRB), acute coronary syndrome (ACS) and a composite criterion of SSE, major bleeding or death. This is a cohort study in the French national healthcare claims and hospitalisation database (SNDS, Système National des Données de Santé) including new users of rivaroxaban, dabigatran, or VKA for SPAF with a follow-up for at least one year and up to two years per subject, and three-year history. The index date will be that of the first dispensation of rivaroxaban, dabigatran, or VKA in 2013 or 2014. Data will be extracted from 2010 to 2015. 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 applicableNone
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 signed01/02/2016
Start date of data collection24/08/2016
Start date of data analysis16/11/2016
Date of interim report, if expected
Date of final study report20/11/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer Pharma AG100
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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