Non-interventional study describing treatment convenience in patients treated with Dabigatran for Stroke Prophylaxis in Atrial Fibrillation (SPAF) (RE-SONANCE)

Study type

• Study topic:
  Disease /health condition

  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

  Other
• Non-interventional study design, other:
  Prospective, observational study

Study drug and medical condition

• Medicinal product name:
  PRADAXA
• Study drug International non-proprietary name (INN) or common name:
  DABIGATRAN ETEXILATE
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AE07) dabigatran etexilate

  dabigatran etexilate
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Patients in Spain with NVAF who were treated with VKAs and subsequently started Pradaxa®, and who gave their consent.; Patients should met all the following inclusion criteria:; 1. Granting informed consent in writing prior to enrolment.; 2. Patients of both sexes ≥ 18 years of age with a diagnosis of NVAF.; 3. Patients treated continuously with VKAs for stroke prophylaxis for at least six months prior to the baseline visit.; 4. Patients switching to treatment with Pradaxa® in accordance with the recommendations of the competent health authorities described in the therapeutic positioning report for NOACs and the authorisations of the various autonomous communities
• 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:
  1087

Study design details

• Study design:
  Prospective, non-interventional national, multi-centre, observational study based on newly collected data. The study enrolled patients in Spain with NVAF who were treated with VKAs and subsequently started Pradaxa®, and who gave their consent.;
• Main study objective:
  Describe the non-valvular AF patient well-being by using the PACTQ-2 at three time-points when (1) being treated with any anticoagulation therapy to prevent stroke/embolism and planned to be switched (baseline to capture VKA treatment perception) when (2) being initiated on Pradaxa® (30-45 days) and (3) continued on Pradaxa® (~180 days).
• Setting:
  Data of NVAF patients were collected from 73 cardiology and non-specialist sites in Spain in 4 autonomous ; communities (Andalucía, Cataluña, País Vasco, and Galicia).;
• Comparators:
  Previous antithrombotic treatment
• Outcomes:
  Outcome 1: Mean PACT-Q2 scores at second and last assessment compared to baseline assessment.Outcome 2: Mean PACT-Q2 score at last assessment compared to second assessment. Characterization of patients according to: Age, Gender, CHA2DS2-VASc score, HAS-BLED score, creatinine clearance, Stroke and/or bleeding related risk factors in medical history and at baseline, Concomitat diseases, Concomitant therapies, Dosing of Pradaxa®, Duration of previous VKA treatment
• Data analysis plan:
  In this non-interventional study, cross-sectional data at 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®. Baseline data will be described using a cross-sectional approach. Data from the longitudinal follow-up will be summarized descriptively.