Treatment Patterns and Bleeding Risks Comparison in Patients Treated with Clopidogrel or Prasugrel during the Index Hospitalisation in Sweden (H7T-MC-B010)

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

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  PRASUGREL
• Medicinal product name, other:
  Clopidegrel
• Medical condition to be studied:
  Acute coronary syndrome

Population studied

• Short description of the study population:
  Patients enrolled in the SCAAR (Swedeheart) who were at least 18 years of age at study entry and were prasugrel- or clopidogrel-treated patients undergoing percutaneous coronary intervention (PCI) with or without acute coronary syndrome (ACS) during the index hospitalisation.
• 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:
  34363

Study design details

• Main study objective:
   To compare the incidence rates of SCAAR-defined major or minor bleeding between only-prasugrel-treated plus prasugrel/clopidogrel-treated patients and only-clopidogrel-treated patients with ACS undergoing PCI (the indicated population for prasugrel) during the index hospitalisation.See report for details
• Outcomes:
  Bleeding
• Data analysis plan:
  For information related to data analysis, please refer to the study report attached