ChaRactErization of patients following aCute venous thrOmboembolism (VTE) and assessment of safety and effectiveness of dabigatran etexilate (DE) in the tReatment and secondarY prevention of acute deep vein thrombosis (DVT) and pulmonary embolism (PE) in comparison to vitamin K antagonist (VKA) in routine clinical practice - RE-COVERY DVT/PE

Study type

• Study topic:
  Disease /health condition

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

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

Study drug and medical condition

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

  dabigatran etexilate

  (B01AA) Vitamin K antagonists

  Vitamin K antagonists

  (B01) ANTITHROMBOTIC AGENTS

  ANTITHROMBOTIC AGENTS
• 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:
  14000

Study design details

• Study design:
  RE-COVERY is a large, multi-national, multi-centre observational study based on new data collection. The study enrolled and characterised patients diagnosed with an acute DVT and/or PE from 229 sites from 5 regions: ; Europe, North America, Middle East, Asia and Latin America.
• Main study objective:
  Objective 1: To characterize the DVT/PE patient population including the initial acute event phase.Objective 2: To analyze the safety and effectiveness of dabigatran etexilate regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen.
• Setting:
  Participation of a country required the approval of dabigatran for the VTE indication prior to study initiation within that country. Selected sites withineach country included those physicians (e.g., specialist and general; practitioners) and facilities (e.g., general practice offices, specialist offices, hospitals, outpatient care centres and anticoagulation clinics) that reflected the clinical practice within that country.;
• Outcomes:
  For Objective 1, the primary outcomes are:-Demographic information (age and gender)-VTE event information (event type and treatment for event)For Objective 2, the primary outcomes are:-Primary safety outcome measure: ISTH Major bleeding-Primary effectiveness outcome measure: symptomatic recurrent VTE including VTE-related mortality, In Objective 2 patients, the secondary outcomes are:-recurrent DVT-recurrent PE-recurrent DVT and PE-VTE-related mortality-all-cause mortality
• Data analysis plan:
  Patient demographics and baseline characteristics will be summarized descriptively. Multivariable regression models and propensity score based methods will be used for the comparative analyses of dabigatran etexilate and VKA patients.