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
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
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)
6. Study drug(s) information
Substance class (ATC Code)C09A (ACE INHIBITORS, PLAIN)
Substance class (ATC Code)C09B (ACE INHIBITORS, COMBINATIONS)
Substance class (ATC Code)C09C (ANGIOTENSIN II ANTAGONISTS, PLAIN)
Substance class (ATC Code)C09D (ANGIOTENSIN II ANTAGONISTS, COMBINATIONS)
Substance class (ATC Code)C10 (LIPID MODIFYING AGENTS)
Substance class (ATC Code)C07 (BETA BLOCKING AGENTS)
Substance class (ATC Code)A10 (DRUGS USED IN DIABETES)
Substance class (ATC Code)N02BA01 (acetylsalicylic acid)
Substance class (ATC Code)B01AC (Platelet aggregation inhibitors excl. heparin)
7. Medical conditions to be studied
Medical condition(s)Yes
Coronary artery disease
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
Other population
Renal impaired
Hepatic impaired
Immunocompromised
Pregnant women
9. Number of subjects
Estimated total number of subjects5600
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources not registered with ENCePP
Healthcare insurance and hospital-discharge summary database, France
Sources of data
Administrative database, e.g. claims database
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Risk assessment
Drug utilisation study
Healthcare resource cost study
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
To assess event rates and cumulative incidence rates of nonfatal MI, nonfatal stroke, major bleeding, and mortality during follow-up, and by specific time periods (follow-up periods 0-1 year, 1-2 years, 2-3 years).
Are there primary outcomes?Yes
Clinical events during follow-up as well as specific follow-up time periods (0-1 year, 1-2 years, 2-3 years): i) A composite of hospitalisation for non-fatal ACS (primary diagnosis ICD-10 codes I20.0-I21) or non-fatal stroke (ICD-10 codes I63-I64), and all-cause mortality; ii) Each event separately; iii) Hospitalisation for fatal and non-fatal major bleeding (ICD10 codes for bleeding).
Are there secondary outcomes?Yes
To describe baseline demographic and clinical characteristics at the time of trigger event and during the year between trigger event and index date.
To describe treatment pattern during follow-up, as well as specific time periods (follow-up periods 0-1 year, 1-2 years, 2-3 years).
To describe health care resource use and costs during follow-up as well as specific follow-up time periods.
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
The follow-up period start on the index date (date corresponding to one calendar year following the patients’ trigger event) for at least one and up to three years until 31 December 2012 (i.e. three years for patients with an index date before 31 December 2009 and one year for patients with 31 December 2011 for index date).
15. Data analysis plan
Please provide a brief summary of the analysis method
Statistical analysis will be carried out by the Bordeaux pharmacoepi according to a documented and approved Statistical Analysis Plan (SAP). The SAP describes statistical analysis as foreseen at the time of planning study. Statistical analysis will be performed after database lock using SAS® software (SAS Institute, last version, North Carolina, USA). Blind double programming will be used for the main outcome measures.
Qualitative variables (dichotomous or categorical) will be described in terms of number and frequency. Quantitative variables will be described in terms of mean, standard deviation, median, first and third quartiles, as well as deciles.
The Kaplan Meier estimate will be used to estimate the incidence of clinical events.
The Cox proportional hazards risk model will be used to assess predictors of the composite clinical events.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
Blin P, Dureau-Pournin C, Lassalle R,et al. Outcomes in patients after myocardial infarction similar to those of the PEGASUS-TIMI 54 trial: A cohort study in the French national claims database. Br J Clin Pharmacol. 2017 Sep;83(9):2056-2065https://doi.org/10.1111/bcp.13291
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
