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

Completed

Conditions studied: Venous Thromboembolism (VTE)

In brief

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)

Key facts

Study ID

NCT04141228

Run by

Bristol-Myers Squibb

People needed

28000

Starts

2016-11-29

Expected to finish

2018-05-31

Last updated by the study team

2019-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution — Flemington, New Jersey, United States

Full record on ClinicalTrials.gov

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