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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04141228
Enrollment
28000
Registered
2019-10-28
Start date
2016-11-29
Completion date
2018-05-31
Last updated
2019-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism (VTE)

Brief 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)

Interventions

None listed

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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/

Design outcomes

Primary

MeasureTime frame
Hospital Length of stay (LOS)During the index hospitalization (Up to 30 days)
Hospital costDuring the index hospitalization (Up to 30 days)

Secondary

MeasureTime frame
Proportion of patients with clinically relevant bleeding (CRB)-related hospital readmissionsDuring 1 month after the index hospitalization
Proportion of patients with any bleeding-related hospital readmissionsDuring 1 month after the index hospitalization
Proportion of patients with VTE-related hospital readmissionsDuring 1 month after the index hospitalization
Proportion of patients with combined VTE- or MB-related hospital readmissionsDuring 1 month after the index hospitalization
Proportion of patients with all-cause hospital readmissionsDuring 1 month after the index hospitalization
Hospital Length of stay (LOS) for major bleeding-related hospital readmissionsDuring 1 month following the VTE hospitalization
Hospital costs of readmissions for major bleeding-related hospital readmissionsDuring 1 month following the VTE hospitalization
Hospital charges of readmissions for major bleeding-related hospital readmissionsDuring 1 month following the VTE hospitalization]
Mean number of hospital readmissions for major bleeding-related hospital readmissionsDuring 1 month following the VTE hospitalization
Hospital LOS for clinically relevant bleeding-related hospital readmissionsDuring 1 month following the VTE hospitalization
Hospital costs of readmissions for clinically relevant bleeding-related hospital readmissionsDuring 1 month following the VTE hospitalization
Hospital charges of readmissions for clinically relevant bleeding-related hospital readmissionsDuring 1 month following the VTE hospitalization
Mean number of hospital readmissions for clinically relevant bleeding-related hospital readmissionsDuring 1 month following the VTE hospitalization
Hospital LOS for any bleeding-related hospital readmissionsDuring 1 month following the VTE hospitalization
Hospital costs of readmissions for VTE-related hospital readmissionsDuring 1 month following the VTE hospitalization
Hospital charges of readmissions for any bleeding-related hospital readmissionsDuring 1 month following the VTE hospitalization
Mean number of hospital readmissions for any bleeding-related hospital readmissionsDuring 1 month following the VTE hospitalization
Hospital LOS for VTE-related hospital readmissionsDuring 1 month following the VTE hospitalization
Hospital charges of readmissions for VTE-related hospital readmissionsDuring 1 month following the VTE hospitalization
Mean number of hospital readmissions for VTE-related hospital readmissionsDuring 1 month following the VTE hospitalization
Hospital LOS for combined VTE- or MB-related hospital readmissionsDuring 1 month following the VTE hospitalization
Hospital costs of readmissions for combined VTE- or MB-related hospital readmissionsDuring 1 month following the VTE hospitalization
Hospital charges of readmissions for combined VTE- or MB-related hospital readmissionsDuring 1 month following the VTE hospitalization
Mean number of hospital readmissions for combined VTE- or MB-related hospital readmissionsDuring 1 month following the VTE hospitalization
Hospital LOS for all-cause hospital readmissionsDuring 1 month following the VTE hospitalization
Hospital costs of readmissions for all-cause hospital readmissionsDuring 1 month following the VTE hospitalization
Hospital charges of readmissions for all-cause hospital readmissionsDuring 1 month following the VTE hospitalization
Mean number of hospital readmissions for all-cause hospital readmissionsDuring 1 month following the VTE hospitalization
Hospital costs of readmissions for any bleeding-related hospital readmissionsDuring 1 month following the VTE hospitalization
Proportion of patients with major bleeding (MB)-related hospital readmissionsDuring 1 month after the index hospitalization

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026