Status: Finalised
First registered on:
06/03/2014
Last updated on:
22/11/2022
1. Study identification
EU PAS Register NumberEUPAS5987
Official titleSecondary Prevention of Acute Coronary Events with Antiplatelet Agents: A cohort study in the SNIIRAM database
Study title acronymSPACE-AA
Study typeOther: Study using the national health insurance and hospital-discharge database
Brief description of the studyThe research question is to evaluate in real-life the use and the impact of ticagrelor and other antiplatelet agent (APA) in the secondary prevention of acute coronary syndrome (ACS). The main objective of effectiveness is to estimate the one-year incidence of the primary effectiveness endpoint (all-cause death, or hospitalisation for ACS, or hospitalisation for ischemic or undefined stroke) during ticagrelor exposure and during other APA exposure for secondary prevention of ACS. The main objective of safety is to estimate the one-year incidence of the primary safety endpoint (hospitalisation for major bleeding) during ticagrelor exposure and during other APA exposure for secondary prevention of ACS. The study is a cohort study in a national healthcare claims and hospitalisations database, of patients hospitalized in 2013 for an ACS with one-year previous history and at least one year follow-up in the database. APA exposure will be defined by claims for drug dispensation after discharge. For each APA, exposure will be defined by the first APA dispensation in the month after discharge, and the time between index ACS and last dispensation + 37 days (30 days of treatment + one week). The follow-up period after index ACS is at least one and up to two years, until 31 December 2014. The study period is defined by the years 2012 to 2014. The study population will be all patients hospitalised between 1 January and 31 December 2013 for an ACS, regardless of the type of treatment. According to the protocol, about 150 000 patients are hospitalised yearly at least once with a main diagnosis of unstable angina or myocardial infarction (MI). Taking into account the PLATO results, around 15 000 (10%) of death, MI or non-fatal stroke are expected after one year of follow-up.
Was this study requested by a regulator?Yes: France
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 signed26/11/2013
Start date of data collection10/02/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report20/12/2016
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)N02BA01 (acetylsalicylic acid)
Substance class (ATC Code)B01AC (Platelet aggregation inhibitors excl. heparin)
7. Medical conditions to be studied
Medical condition(s)Yes
Acute coronary syndrome
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
9. Number of subjects
Estimated total number of subjects150000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources not registered with ENCePP
National 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
Effectiveness evaluation
Primary scope : Effectiveness evaluation
12. Main objective(s)
What is the main objective of the study?
Main objective of effectiveness: Estimate the 1-year incidence of the primary effectiveness endpoint (all-cause death, hospitalisation for ACS, or for ischemic or undefined stroke) during ticagrelor exposure and during other APA exposure for secondary prevention of ACS.
Main objective of safety: Estimate the 1-year incidence of the primary safety endpoint (hospitalisation for major bleeding).
Are there primary outcomes?Yes
The primary effectiveness endpoint is a composite of all-cause death, hospitalisation for ACS, and hospitalisation for an ischemic or undefined stroke.
The primary safety endpoint includes following events: hospitalisation for bleeding events (including haemorrhagic stroke).
Are there secondary outcomes?Yes
The secondary effectiveness endpoint is a composite of all-cause death, hospitalisation for ACS, hospitalisation for percutaneous coronary intervention or coronary artery by-pass grafting, and hospitalisation for an ischemic or undefined stroke.
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 SCA date (between 1 January to 31 December 2013) for at least one and up to two years, until 31 December 2014.
15. Data analysis plan
Please provide a brief summary of the analysis method
Statistical analysis will be carried out 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.
Primary and secondary endpoints will be analysed using survival methods: The Kaplan Meier estimate for incidence of events and the Cox proportional hazard risk model to compare incidence between APA, with gender, age, initial SCA management and high-dimensional propensity score (hdPS) adjustment and matching.
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, Bénichou J, et al. Secondary prevention of acute coronary events with antiplatelet agents (SPACE-AA): One-year real-world effectiveness and safety cohort study in the French nationwide claims database. Atherosclerosis 281 (2019) 98-106https://doi.org/10.1016/j.atherosclerosis.2018.11.037
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
