Status: FinalisedLast updated on: 18/02/2019
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
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 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) 
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