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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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status

Completed

Conditions

Venous Thromboembolism (VTE)

Study type

Observational

Funder types

Industry

Identifiers

NCT04141228
CV185-589

Details and patient eligibility

About

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)

Enrollment

28,000 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

28,000 participants in 2 patient groups

Patients receiving apixaban
Description:
With or without low molecular weight heparin in the inpatient/emergency department (ED) setting
Patients receiving warfarin
Description:
With or without low molecular weight heparin in the inpatient/emergency department (ED) setting

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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