Status: Finalised First registered on: 12/02/2014
Last updated on: 22/11/2022
1. Study identification
EU PAS Register NumberEUPAS5816
Official titleHealth Outcomes, Resource Use, costs in patients with Stable coronary artery disease a cohort study in the EGB database
Study title acronymHORUS
Study typeOther: Study using the national health insurance and hospital-discharge database
Brief description of the studyThe research question is to assess the burden of disease (healthcare resource utilization and cost, atherothrombotic events, major bleeding events, and mortality) in a French real world setting among 3 populations: i) Stable CAD population (patients with a history of MI at least one year ago), ii) High risk stable CAD population (stable CAD patients with additional risk factors), iii) PEGASUS-like population (high risk stable CAD patients with other main PEGASUS inclusion and exclusion criteria). The index date is defined by the date corresponding to one calendar year (365 days) following the patient's trigger event (i.e. from 1 January 2006 to 31 December 2011). The trigger event is defined by the date of a hospital record indicating myocardial infarctions (MI) or acute coronary syndrome (ACS) between 1 January 2005 and 31 December 2010. The follow-up period after index date is at least one and up to three years, until 31 December 2012 (ie three years for patients with an index date before 31 December 2009 and one year for patients with 31 December 2011 for index date). The study period is defined by the years 2005 to 2012. The study population will be all adult patients (≥18 years at the time of the trigger event) with a trigger event between 1 January 2005 and 31 December 2010. According to the protocol, about 5 600 patients with an ACS or MI have been identified in the EGB between 1 January 2005 and 31 December 2010.
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 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 signed28/10/2013
Start date of data collection20/11/2013
Start date of data analysis
Date of interim report, if expected
Date of final study report05/10/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAztrazeneca100
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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