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Completed

NCT Number: NCT04141228

A Study of Hospital Healthcare Use and Cost in Patients in the Hospital With a Venous Thromboembolism (VTE) Treated With Apixaban or Warfarin in the US

A study involving real-world database analysis to evaluate the hospital healthcare utilization and costs, and all-cause, major bleeding-, clinically relevant bleeding-, any bleeding-, and venous thromboembolism (VTE)-related hospital readmissions among hospitalized VTE patients treated with apixaban or warfarin, with or without low molecular weight heparin (LMWH)

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Key information

Conditions

Venous Thromboembolism (VTE) Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Flemington, New Jersey, 08822, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have a primary diagnosis of VTE identified by ICD-9-CM or ICD-10 codes from the Premier Hospital database between 01-Aug-2014 and 31-May-2016
  • Age 18 years or older as of index hospitalization with VTE diagnosis
  • Patients will be required to have received apixaban or warfarin with or without LMWH (index drugs) during the index hospitalizations

Exclusion criteria

  • Received both apixaban and warfarin during the index hospitalization. This exclusion criterion will allow to cleanly group patients into the apixaban and warfarin usage cohorts.
  • Received any other Direct oral anticoagulants (DOAC) including rivaroxaban, dabigatran, and edoxaban during the index hospitalization
  • Have any primary or secondary diagnosis code for Atrial fibrillation/Atrial flutter (AF/AFL), or pregnancy, or records of inferior vena cava filter (IVCF) usage during the index hospitalizations or the baseline periods.
  • Patients transferred from other facilities

Other protocol-defined inclusion/exclusion criteria could apply

Treatment and study plan

Primary outcomes

  1. Hospital Length of stay (LOS)

    Time frame: During the index hospitalization (Up to 30 days)

  2. Hospital cost

    Time frame: During the index hospitalization (Up to 30 days)

Secondary outcomes

  1. Proportion of patients with major bleeding (MB)-related hospital readmissions

    Time frame: During 1 month after the index hospitalization

  2. Proportion of patients with clinically relevant bleeding (CRB)-related hospital readmissions

    Time frame: During 1 month after the index hospitalization

  3. Proportion of patients with any bleeding-related hospital readmissions

    Time frame: During 1 month after the index hospitalization

  4. Proportion of patients with VTE-related hospital readmissions

    Time frame: During 1 month after the index hospitalization

  5. Proportion of patients with combined VTE- or MB-related hospital readmissions

    Time frame: During 1 month after the index hospitalization

  6. Proportion of patients with all-cause hospital readmissions

    Time frame: During 1 month after the index hospitalization

  7. Hospital Length of stay (LOS) for major bleeding-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  8. Hospital costs of readmissions for major bleeding-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  9. Hospital charges of readmissions for major bleeding-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization]

  10. Mean number of hospital readmissions for major bleeding-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  11. Hospital LOS for clinically relevant bleeding-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  12. Hospital costs of readmissions for clinically relevant bleeding-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  13. Hospital charges of readmissions for clinically relevant bleeding-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  14. Mean number of hospital readmissions for clinically relevant bleeding-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  15. Hospital LOS for any bleeding-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  16. Hospital costs of readmissions for any bleeding-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  17. Hospital charges of readmissions for any bleeding-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  18. Mean number of hospital readmissions for any bleeding-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  19. Hospital LOS for VTE-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  20. Hospital costs of readmissions for VTE-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  21. Hospital charges of readmissions for VTE-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  22. Mean number of hospital readmissions for VTE-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  23. Hospital LOS for combined VTE- or MB-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  24. Hospital costs of readmissions for combined VTE- or MB-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  25. Hospital charges of readmissions for combined VTE- or MB-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  26. Mean number of hospital readmissions for combined VTE- or MB-related hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  27. Hospital LOS for all-cause hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  28. Hospital costs of readmissions for all-cause hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  29. Hospital charges of readmissions for all-cause hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

  30. Mean number of hospital readmissions for all-cause hospital readmissions

    Time frame: During 1 month following the VTE hospitalization

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Evaluation of Hospital Healthcare Utilization and Costs Among Hospitalized Venous Thromboembolism (VTE) Patients Treated With Apixaban or Warfarin in the United States

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 28, 2019
Registry last updated
Oct 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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