Status: FinalisedLast updated on: 15/02/2019
1. Study identification
EU PAS Register NumberEUPAS11521
Official titleBenefit and risk of AntiThrombotic Treatments after Orthopaedic Surgery in real-life settings: a cohort study in the SNIIRAM claims and hospitalisation database
Study title acronymATTOS
Study typeOther: Study using the SNIIRAM claims and hospitalisation database
Brief description of the studyEliquis® (apixaban), an antithrombotic agent has obtained market authorization in the indication “Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip or knee replacement surgery (THR or TKR)”. In this context, the French Transparency Commission requested a cohort study of patients treated in France by Eliquis® under real-life condition. To adress the HAS request, an historical cohort study will be formed using a national healthcare claims (SNIIRAM) linked to the national hospital-discharge summaries database. This cohort will include all adults with an antithrombotic agent reimbursement within one week after discharge for an orthopaedic procedure (THR, TKR and other orthopaedic procedures) between 1 January 2013 and 30 September 2014, and with a 3-year database history and a follow-up of 3 months. The primary objectives of the study are to estimate the cumulative incidence of VTE (effectiveness) and the cumulative incidence of clinically significant bleeding (safety) in real-life clinical settings in France after a THR, a TKR, and after another orthopaedic procedure over a 3-month post-surgery period, according to the initial antithrombotic treatment. The secondary objectives are to estimate the cumulative incidence of all-cause death after a THR, after a TKR, and after another orthopaedic procedure; to compare cumulative incidence of VTE, of clinically significant bleeding, and of all-cause death over a 3-month post surgery period between Eliquis® and other antithrombotic; to describe the treated population; to describe conditions of Eliquis® use and other antithrombotic treatments; and to assess the impact of each antithrombotic treatment on the healthcare system during the study period. The statistical analysis will be performed separately for THR, TKR, and other orthopaedic procedures, according to the treatment group (first antithrombotic agent dispensed within a week after discharge).
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 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 Dr
Last name BLIN
First name Patrick
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 signed17/04/2015
Start date of data collection01/04/201615/06/2016
Start date of data analysis31/05/201615/09/2016
Date of interim report, if expected
Date of final study report31/10/201629/05/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBristol-Myers Squibb100
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 1Université de Bordeaux – Bâtiment du Tondu – Case 41 – 146 rue Léo Saignat
Address line 2 
Address line 3 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
Public Enquiries
Title Dr 
Last name BLIN 
First name Patrick 
Address line 1Université de Bordeaux – Bâtiment du Tondu – Case 41 – 146 rue Léo Saignat 
Address line 2 
Address line 3 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
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