Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation --- Impact of Conventional Oral Anticoagulant (OAC) Compared With Novel Oral Anticoagulant (NOAC) (PASSION)

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

  dabigatran etexilate

Population studied

• Short description of the study population:
  Patients with non-valvular atrial fibrillation (NVAF) receiving Pradaxa® or VKA for stroke prevention
• 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)
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  Objective 1 To describe the treatment perception from patients with non-valvular atrial fibrillation (NVAF) receiving Pradaxa® or VKA for stroke prevention by using the self-estimation questionnaire of PACT-Q during a 6-month study period. Objective 2 To investigate the patient’s characteristics.
• Outcomes:
  Cohort A (patients switched from VKA to Pradaxa) Mean PACT-Q2 scores at the second (30-45 days) and the last assessment (150-210 days) compared to baseline assessment. Cohort B (patients newly initiated Pradaxa or VKA) Mean PACT-Q2 scores at the second (30-45 days) and the last assessment (150-210 days) compared between 2 treatment groups. Cohort A (patients switched from VKA to Pradaxa) Mean PACT-Q2 score at the last assessment (150-210 days) compared to the second assessment (30-45 days). Cohort B (patients newly initiated Pradaxa or VKA) Description of mean PACT-Q1 score at baseline.
• Data analysis plan:
  Baseline demographic and clinical characteristics Descriptive summary will be presented for baseline demographic and clinical characteristics of all patients enrolled in Cohort A, Cohort B Pradaxa® initiators, and Cohort B VKA initiators, respectively. For continuous variables, number of patients, mean, standard deviation (SD), median, Q1 (lower quartile), Q3 (upper quartile), minimum, and maximum will be presented. For categorical variables, frequency and percentage will be presented for each category.