Study type

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

PRADAXA
Population studied

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.