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 (1160.247 (RE-SONANCE))

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Evaluation of the patients perception on anticoagulant treatment, including convenience, burden of disease and treatment and treatment satisfaction
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B01AA) Vitamin K antagonists

  Vitamin K antagonists

  (B01AE07) dabigatran etexilate

  dabigatran etexilate
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Two different groups (cohorts) of patients will be investigated: - Cohort A: non-valvular atrial fibrillation (NVAF) patients who used VKA for at least 3 months prior to study enrolment and are switched to Pradaxa. - Cohort B: newly diagnosed NVAF patients who are initiated to either Pradaxa or VKA treatment upon study enrolment.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  Non-valvular atrial fibrillation (NVAF) patients
• Estimated number of subjects:
  1851

Study design details

• Main study objective:
  To describe how patients with non-valvular atrial fibrillation (NVAF)perceive anticoagulant treatment, with Pradaxa or VKA, for stroke prevention, using the PACT-Q questionnaires.
• Outcomes:
  For Cohort A (NVAF patients on VKA who are switched toPradaxa®): Mean PACT-Q2 scores at second and last assessment compared to baseline assessment.For Cohort B (newly diagnosed NVAF patients initiated to eitherVKA or Pradaxa®): Mean PACT-Q2 scores at second and last assessment compared between treatment groups. For Cohort A (patients switched to Pradaxa®): Mean PACT-Q2 scores at last assessment compared to second assessment.For Cohort B (patients newly initiated to VKA or Pradaxa®):Description of PACT-Q1 items at baseline.
• Data analysis plan:
  In this non-interventional study, baseline and longitudinal follow-up data over 6 months will be collected for non-valvular AF patients with a current VKA therapy and subsequent initiation of Pradaxa® in Cohort A, and for newly diagnosed AF patients initiated on Pradaxa® or VKA in Cohort B.Data from baseline and the longitudinal follow-up will be summarized descriptively. For Cohort A, mean PACT-Q2 scores between assessments will be compared using paired t-tests. For Cohort B, mean PACT-Q2 scores between Pradaxa® and VKA patients will be compared using propensity score matched analysis.