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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B01AC) Platelet aggregation inhibitors excl. heparin

  Platelet aggregation inhibitors excl. heparin

  (N02BA01) acetylsalicylic acid

  acetylsalicylic acid
• Medical condition to be studied:
  Acute coronary syndrome

Population studied

• Short description of the study population:
  Subject with acute coronary syndrome treated with ticagrelor and other antiplatelet agents obtained from the national healthcare claims and hospitalisations database for the study period of 2012 to 2014.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with acute coronary syndrome
• Estimated number of subjects:
  150000

Study design details

• Main study objective:
  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).
• Outcomes:
  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). 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.
• Data analysis plan:
  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.