STUDY ON THE PREVENTION OF CARDIOVASCULAR EVENTS BY ANTIPLATELET AGENTS AFTER ACUTE CORONARY SYNDROME (AReMIS)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-cohort study

Study drug and medical condition

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

  Platelet aggregation inhibitors excl. heparin
• Medical condition to be studied:
  Myocardial infarction

  Acute coronary syndrome

Population studied

• 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)
• Estimated number of subjects:
  3750

Study design details

• Main study objective:
  The Primary objective of this study is to compare the relative risk of new myocardial infarction (MI) or cardiac death in patients with a history of acute coronary syndrome ('ACS': unstable angina or myocardial infarction), using ticagrelor, clopidogrel or prasugrel (if applicable) or none of these treatments, where aspirin is considered a covariate.
• Outcomes:
  The recurrent myocardial infarction (rMI) or cardiac death, Stroke, major (requiring hospitalization) and non-major bleeding, and death
• Data analysis plan:
  Analyses will follow that of a matched case control study where cases are identified prospectively in a cohort and matched at each time point of occurrence to available controls in the cohort (without the events of interest), for age, sex and type of ACS at entry in the cohort (angina or MI). Odds ratios will be calculated using conditional logistic regression. All risk factors will be documented for cases and referents, which will be compared regarding the use of ticagrelor vs. clopidogrel or vs. prasugrel (in PCI if its use is sufficient). An adjusted odds ratio will be estimated in each case. Secondary analysis, using the cohort of reference will historically estimate the incidence of rMI, stroke and bleeding from the time of the occurrence of 'index' acute coronary syndrome up to 12 months after the ACS. The incidence rates of recurrent MI, stroke, death and bleeding will be produced, with their confidence intervals, by antiplatelet therapy.