Observational study of post-myocardial infarction with a long follow-up (EOLE)

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
• Data collection methods:
  Primary data collection

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

  (C07A) BETA BLOCKING AGENTS

  BETA BLOCKING AGENTS

  (C09A) ACE INHIBITORS, PLAIN

  ACE INHIBITORS, PLAIN

  (C09C) ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN

  ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN

  (C10AA) HMG CoA reductase inhibitors

  HMG CoA reductase inhibitors

  (C10AB) Fibrates

  Fibrates

  (C10AC) Bile acid sequestrants

  Bile acid sequestrants

  (C10AD) Nicotinic acid and derivatives

  Nicotinic acid and derivatives
• Medical condition to be studied:
  Myocardial infarction

Population studied

• Short description of the study population:
  Subjects with post-myocardial infarction treated with cardiovascular drugs including beta-blockers, acetylsalicylic acid or other antiplatelet agents, statins or other lipid lowering agent, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, and omega-3 supplementation identified from April 2006 to June 2009.
• 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:
  Myocardial infarction patients
• Estimated number of subjects:
  5527

Study design details

• Main study objective:
  To assess the impact of recommended secondary prevention drugs and dietary lifestyle guidelines in real-life practice to all cause mortality in secondary prevention of myocardial infarction in France after 6 years of follow-up.
• Outcomes:
  All cause mortality at 6 years follow-up, Coronary & cardiovascular mortalityCoronary & cardiovascular morbi-mortalityPersistence of prescription of recommended secondary prevention drugs (according to the European & the French recommendations)Differential between cardiologist prescription & patient declaration for recommended secondary prevention drugsDietary lifestyle guidelines follow-upEvolution of self-perceived health
• Data analysis plan:
  Statistical analysis will be carried out by the Bordeaux pharmacoepi according to a documented and approved Statistical Analysis Plan (SAP). 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 occurrence of all-cause death. The Cox proportional hazard regression model adjusted for gender, age, cardiovascular risk factors, other myocardial infarction prevention drugs and propensity score to be exposed at inclusion will be used to estimate the risk of death in patients exposed and not exposed to each secondary prevention drug.