Non-interventional study describing patients´ perception on anticoagulant treatment and treatment convenience when treated with Pradaxa® or Vitamin K Antagonist for Stroke Prophylaxis in Atrial Fibrillation (RELATE)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  PRADAXA
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Patients aged 18 years and older with non-valvular atrial fibrillation (AF) in South East Asia South Korea (SEASK) with a current Vitamin K Antagonist (VKA) therapy and subsequent initiation of Pradaxa® (Cohort A) OR patients being newly diagnosed with AF and initiated on Pradaxa® or VKA (Cohort B).
• 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:
  Atrial fibrillation patients
• Estimated number of subjects:
  1385

Study design details

• Main study objective:
  Describe the atrial fibrillation patient´s treatment perception by using the PACT-Q at three time-points at baseline, during initiation period and during the continuation period.
• Outcomes:
  Primary outcomeFor Cohort A (switcher):- Mean PACT-Q2 scores at second and last assessment compared tobaseline assessmentFor Cohort B (newly initiated):- Mean PACT-Q2 scores at second and last assessment between treatment groups, Secondary outcome:For Cohort A (switcher):- Mean PACT-Q2 score at last assessment compared to second assessmentFor Cohort B (newly initiated):- Description of PACT-Q1 items at baseline
• Data analysis plan:
  Baseline data will be analyzed using a descriptive approach. Data from the longitudinal follow-up will be summarized descriptively. For Cohort A, mean differences in PACT-Q2 scores between assessments will be assessed using paired t-tests. For Cohort B, mean differences in PACT-Q2 scores between Pradaxa® and VKA patients will be assessed using propensity score matched analysis.Due to the nature of this non-interventional study, there is no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses are descriptive in nature and confidence intervals and p-values from statistical models are used for exploratory purposes.