Post-authorisation study to evaluate the effectiveness of the risk minimisation activities in the treatment of SPAF (Risk minimisation in SPAF)

Study type

• Study topic:
  Disease /health condition

  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Not applicable
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Other
• If ‘Not applicable’, further details on the study type:
  Active surveillance, survey
• If ‘other’, further details on the scope of the study:
  Risk awareness
• Data collection methods:
  Primary data collection

Study drug and medical condition

• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Physicians: Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).; Patients: Atrial fibrillation (AF) patients on treatment with Pradaxa®.
• 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 atrial fibrillation
• Estimated number of subjects:
  1200

Study design details

• Main study objective:
  The key focus of this survey will be to collect data on physicians’ awareness of the content of the Pradaxa® Prescriber Guide and the extent to which risk awareness is communicated to patients. The data collected with AF patients will show if and how well this information isreceived and understood.
• Outcomes:
  Physician’s knowledge and recommendations to their patients onappropriate dosing and minimizing the risk of bleeding whentreated with Pradaxa®. Patients’ understanding of the disease, bleeding signs, what to do in case of bleeding and how to deal with emergency situations
• Data analysis plan:
  Descriptive Statistics:For both Physician and Patient Surveys, all estimates of proportions andmeans will be presented for the following groups: the entire populations for physicians and for patients, stratified by country.