Venous Thromboembolism Treatment (VOLT)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  This is a retrospective, observational, nationwide cohort study using administrative registry data.

Study drug and medical condition

• Name of medicine:
  ELIQUIS

  LIXIANA

  PRADAXA

  XARELTO
• Study drug International non-proprietary name (INN) or common name:
  WARFARIN
• Medical condition to be studied:
  Deep vein thrombosis

  Pulmonary embolism

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:
  20000

Study design details

• Main study objective:
  Phase I involves a descriptive assessment of patient characteristics and treatment patterns in each country as well as detailed power calculations. If the study is adequately powered for comparative analyses, it will proceed to Phase II. Phase II involves analyses of comparative effectiveness and safety, utilising warfarin as the comparator.
• Outcomes:
  Primary efficacy, Recurrent VTE Primary safety, Major Bleeding, Treatment interruption, Complete treatment discontinuation, Treatment switching, Treatment persistence, GI bleeding, intracranial haemorrhage, other bleeding, health care resource utilisation
• Data analysis plan:
  Phase I of this study would be descriptive in nature, including the number, percentage of patients who discontinue, interrupt, and switch treatment. Patient characteristics will be summarised using numbers and percentages for categorical values and descriptive statistics (mean, SD, median, minimum, maximum and IQR) for continuous. Descriptive analyses will also be performed for specific subgroups. Phase II involves comparative safety and effectiveness analyses, which for this study includes a number of clinical endpoints (recurrent VTE, major bleeding, overall and by site (GI, ICH, other sites) and health care resource utilisation.