Secondary Prevention of Acute Coronary Events with Antiplatelet Agents: A cohort study in the SNIIRAM database (SPACE-AA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49886
• EU PAS number:
  EUPAS5987
• Study ID:
  49886
• Official title and acronym:
  Secondary Prevention of Acute Coronary Events with Antiplatelet Agents: A cohort study in the SNIIRAM database (SPACE-AA)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The 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.
• Study status:
  Finalised

Research institution and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Study timelines

Date when funding contract was signed

Actual: 26/11/2013

Study start date

Actual: 10/02/2015

Date of final study report

Actual: 20/12/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Aztrazeneca

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable