Non-interventional study describing patients´ perception on anticoagulant treatment and treatment convenience when treated with Pradaxa or Vitamine K Antagonist for Stroke Prevention in Non-Valvular Atrial Fibrillation (Patient convenience study (RE-SONANCE))

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Evaluation of patient-reported outcomes
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  PRADAXA
• Medicinal product name, other:
  Pradaxa®(Dabigatran etexilate), or Vitamin K Antagonist (VKA);
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AE07) dabigatran etexilate

  dabigatran etexilate

  (B01AA) Vitamin K antagonists

  Vitamin K antagonists
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Age groups:
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  9000

Study design details

• Study design:
  Non-interventional study of NVAF patients in Europe with a current VKA therapy and subsequent initiation of Pradaxa® OR patients being newly diagnosed with NVAF and initiated on Pradaxa® or VKA
• Main study objective:
  To describe how patients with non-valvular atrial fibrillation (NVAF)preceive anticoagulant treatment, with Pradaxa or VKA, for stroke prevention, using the PACT-Q questionnaires.
• Setting:
  Data from approximately 9 000 patients were planned to be collected from approximately 800 sites from 12 Central & Eastern European countries (Russia, Poland, Romania, Hungary, Austria, Czech Republic, Latvia, Estonia, Slovenia, Bulgaria, Serbia, Croatia) and Israel.
• Outcomes:
  For Cohort A (NVAF patients on VKA who are switched to Pradaxa®): Mean PACT-Q2 scores at second and last assessment compared to baseline assessment.For Cohort B (newly diagnosed NVAF patients initiated to either VKA 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.