Risk of subsequent cardiovascular events in patients discharged after myocardial infarction - Perseus (PERSEUS)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Acute myocardial infarction

Population studied

• Short description of the study population:
  Myocardial infarction patients with 12-month dual antiplatelet treatment.
• Age groups:
  Adolescents (12 to < 18 years)

  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:
  44000

Study design details

• Main study objective:
  The main objective is to describe the risk development and risk factors of subsequent cardiovascular events in patients discharged from hospital after myocardial infarction. We study all patients alive one week after the discharge, and because the mortality is high during the first year, the main focus is in patients surviving without subsequent myocardial infarction or stroke more than one year.
• Outcomes:
  Myocardial infarction (ICD-10 I21-I22), Stroke (total) (ICD-10 I61-64), Cardiovascular mortality (death due to ICD-10 I21-I22, I61-64, I50, I48, I20.0), Composite end-point (deaths due to MI, stroke or cardiovascular mortality causes specified above), Overall mortality (death from any cause), Heart failure (ICD-10 I50), Atrial fibrillation (ICD-10 I48), Unstable angina pectoris (ICD-10 I20.0), Major bleedings (ICD-10 D62, D68.3, I60, J94.2, K22.1, K22.3, K22.6, K25.0, K25.2, K25.4, K25.6, K26.0, K26.2, K26.4, K26.6, K27.0, K27.4, K27.6, K28.0, K28.2, K28.4, K28.6, K29.0, K62.5, K63.1, K63.3, K92.0-K92.2, R04, R31, S06.4-S06.6)
• Data analysis plan:
  R language will be used for in data management for creating the analysis database and in statistical analysis for creating tabulations and graphics as well as in all statistical modelling. If a variable is totally missing it is excluded from the analysis. If a variable is missing for only some of the patients a missing data category is added and used in the analysis. The principles of the statistical analysis by objectives are outlined in protocol. More detailed statistical analysis plans will be written separately.