Health Outcomes, Resource Use, costs in patients with Stable coronary artery disease a cohort study in the EGB database (HORUS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49883
• EU PAS number:
  EUPAS5816
• Study ID:
  49883
• Official title and acronym:
  Health Outcomes, Resource Use, costs in patients with Stable coronary artery disease a cohort study in the EGB database (HORUS)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The 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.
• Study status:
  Finalised

Research institution and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Contact details

Patrick Blin

Study contact

[e-mail]

Nicholas Moore

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual: 28/10/2013

Data collection

Actual: 20/11/2013

Date of final study report

Actual: 05/10/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Aztrazeneca

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable