Pradaxa Initiation Post-Stroke Study: SITS-Pradaxa 1. A retrospective analysis from the SITS-AF Registry on treatment initiation of dabigatran etexilate in non-valvular atrial fibrillation patients hospitalized with acute ischemic stroke

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

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

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B01A) ANTITHROMBOTIC AGENTS

  ANTITHROMBOTIC AGENTS

  (B01AE07) dabigatran etexilate

  dabigatran etexilate
• Medical condition to be studied:
  Atrial fibrillation

  Ischaemic stroke

Population studied

• Short description of the study population:
  Patients with non-valvular atrial fibrillation (NVAF) presenting with their first ever acute ischemic stroke who are registered in the SITS International Registry from 1 July 2014 until approximately 31 July 2018 will be included in the study.; Inclusion criteria; 1. Patients with non-valvular Atrial Fibrillation (NVAF); 2. Patients presenting with their first acute ischemic stroke; 3. ≥ 18 years of age; Exclusion criteria; 1. Documentation that the patient was enrolled or is planned to be enrolled in an investigational clinical trial at the time of the onset of the index event and for the; duration of the data collection
• 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:
  1000

Study design details

• Main study objective:
  To evaluate the timing of dabigatran treatment initiation in patients with non-valvular atrial fibrillation (NVAF) after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke
• Outcomes:
  The time lapsed from the index event to the initiation of the dabigatran treatment. This will be further categorized in specified time periods.The following time periods will be considered, but could be revised (e.g. merging categories) depending on sample size 0-24h, >24-72h, >3-7d >7-14d, >14-28d, >28d-3m. Description of baseline characteristics for patients treated with dabigatran according to time of dabigatran initiation.Description of self-reported factors important for physician’s decision when to initiate dabigatran and which dabigatran dose is used in the post-ischemic stroke setting for secondary prevention of stroke and safety in NVAF.
• Data analysis plan:
  Descriptive statistics (absolute and relative frequencies, means, standard deviations, medians, inter quartile ranges, minimum and maximum values, 95% confidence intervals and proportions, as appropriate) for baseline and demographic characteristics for all included patients will be provided. For the baseline characteristics the percentage proportions will be calculated by dividing the number of events by the total number of patients, excluding missing or unknown cases, as was generally done in previous publications (e.g. SITS-MOST and / or SITS-ISTR).The main analysis will focus on NVAF patients presenting with first ischemic acute stroke and treated with dabigatran within 3 months of index event.For patients initiated on dabigatran within 3 months of index event, the time to dabigatran treatment initiation will be summarized as a continuous variable as well as categorical.