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CompletedNCT04141228Updated Oct 28, 2019

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

An observational study in Venous Thromboembolism (VTE), sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-28.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
28,000
Ages
18 Years and older
Sex
All
01

Study summary

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)

02

Conditions studied

  • Venous Thromboembolism (VTE)
03

In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.

This study's enrollment of 28,000 is above the median of 500 across 344 observational studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study population will include patients with a hospital or ED discharge International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) or ICD-10 code indicating a primary diagnosis of VTE identified from the Premier Hospital database between 01-Aug-2014 and 31-May-2016. Patients who received apixaban or warfarin with or without LMWH during any time of the hospitalization (from admission to discharge) will be identified. Patients receiving both apixaban and warfarin, or any other direct oral anticoagulant (DOAC), including rivaroxaban, dabigatran, and edoxaban, during the index hospitalizations will be excluded from the study population. Patients will be required to have no evidence of atrial fibrillation (AF) or atrial flutter (AFL) during the index hospitalizations or the baseline periods.

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

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

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
28,000 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients receiving apixaban

    With or without low molecular weight heparin in the inpatient/emergency department (ED) setting

  • Patients receiving warfarin

    With or without low molecular weight heparin in the inpatient/emergency department (ED) setting

06

What researchers measure

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

07

Study locations

1 site
  • Local Institution
    Flemington, New Jersey 08822, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04141228
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Oct 28, 2019
Start date
Nov 29, 2016
Primary completion
Apr 30, 2018
Completion
May 31, 2018
Last update
Oct 28, 2019

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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