Status: Finalised First registered on: 07/01/2019
Last updated on: 27/10/2020
1. Study identification
EU PAS Register NumberEUPAS27402
Official titleAssessment of The High risk and unmEt Need in patients with coronary artery disease and type 2 diabetes in France
Study title acronymATHENA-F
Study typeOther: Historical cohort study using the SNDS, the French nationwide claims database
Brief description of the studyAstraZeneca is working on an indication extension of ticagrelor for the prevention of cardiovascular (CV) death, myocardial infarction (MI) or stroke in patients with coronary arterial disease (CAD), but without medical history of previous MI or stroke at high risk of atherothrombotic events due to type II diabetes mellitus (T2DM). The ATHENA-F study purpose is to assess the prevalence and burden of CAD-T2DM without prior MI or stroke in France, as well as of the population with inclusion and exclusion criteria of the THEMIS randomized controlled trial (THEMIS-like population), using the French nationwide claims database (SNDS). The first study population will include all T2DM patients identified in 2013-2014 with CAD but without MI or stroke history, and affiliated to the general scheme from 2008 to 2016 (data extraction period). Each patient will be followed 2 years or until death and will have 5-year history in the database. THEMIS-like population will include patients of this first population aged ≥50 years at index, without history of intracranial bleeding, renal failure requiring dialysis, cirrhosis of liver or liver cancer, gastro-intestinal bleeding (within 6 months), antiplatelet agent or anticoagulant treatment within 2 months around index date. For prevalent patients (both T2DM and CAD), index date will be 01/01/2013; for incident patients the first date of the second diagnosis between T2DM or CAD. The number of CAD-T2DM patients is estimated to 550,000 patients in the SNDS, and the prevalence of the two study populations will be assessed on 01/01/2013 and 31/12/2014. The CV events (stroke, MI, CV death, all-cause death, heart failure, bleeding, and composite CV events of MI, stroke, CV death) during the study period will be described in terms of crude incidence rate (Normal approximation), cumulative incidence rate (Kaplan-Meier estimator or Cumulative Incidence Function), and risk factors of the composite CV events (Cox proportional hazards model).
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.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 signed12/07/2018
Start date of data collection31/12/201819/06/2019
Start date of data analysis01/03/201919/06/2019
Date of interim report, if expected
Date of final study report28/02/202020/03/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
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 1University of Bordeaux
Address line 2146 Rue Léo Saignat 
Address line 3Bâtiment du Tondu - Case 41 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
Email address patrick.blin@u-bordeaux.fr
Public Enquiries
Title Dr 
Last name Blin 
First name Patrick 
Address line 1University of Bordeaux 
Address line 2146 Rue Léo Saignat 
Address line 3Bâtiment du Tondu - Case 41 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
Email address patrick.blin@u-bordeaux.fr 
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