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

Venous Thromboembolism (VTE) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04141228
• Other study ID #: CV185-589
• Status: Completed
• Start date: November 29, 2016
• Est. completion date: May 31, 2018

Study information

• Verified date: October 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28000
• Est. completion date: May 31, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism
• Venous Thromboembolism (VTE)

Locations

Country	Name	City	State
United States	Local Institution	Flemington	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Length of stay (LOS)		During the index hospitalization (Up to 30 days)
Primary	Hospital cost		During the index hospitalization (Up to 30 days)
Secondary	Proportion of patients with major bleeding (MB)-related hospital readmissions		During 1 month after the index hospitalization
Secondary	Proportion of patients with clinically relevant bleeding (CRB)-related hospital readmissions		During 1 month after the index hospitalization
Secondary	Proportion of patients with any bleeding-related hospital readmissions		During 1 month after the index hospitalization
Secondary	Proportion of patients with VTE-related hospital readmissions		During 1 month after the index hospitalization
Secondary	Proportion of patients with combined VTE- or MB-related hospital readmissions		During 1 month after the index hospitalization
Secondary	Proportion of patients with all-cause hospital readmissions		During 1 month after the index hospitalization
Secondary	Hospital Length of stay (LOS) for major bleeding-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Hospital costs of readmissions for major bleeding-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Hospital charges of readmissions for major bleeding-related hospital readmissions		During 1 month following the VTE hospitalization]
Secondary	Mean number of hospital readmissions for major bleeding-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Hospital LOS for clinically relevant bleeding-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Hospital costs of readmissions for clinically relevant bleeding-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Hospital charges of readmissions for clinically relevant bleeding-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Mean number of hospital readmissions for clinically relevant bleeding-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Hospital LOS for any bleeding-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Hospital costs of readmissions for any bleeding-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Hospital charges of readmissions for any bleeding-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Mean number of hospital readmissions for any bleeding-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Hospital LOS for VTE-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Hospital costs of readmissions for VTE-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Hospital charges of readmissions for VTE-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Mean number of hospital readmissions for VTE-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Hospital LOS for combined VTE- or MB-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Hospital costs of readmissions for combined VTE- or MB-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Hospital charges of readmissions for combined VTE- or MB-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Mean number of hospital readmissions for combined VTE- or MB-related hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Hospital LOS for all-cause hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Hospital costs of readmissions for all-cause hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Hospital charges of readmissions for all-cause hospital readmissions		During 1 month following the VTE hospitalization
Secondary	Mean number of hospital readmissions for all-cause hospital readmissions		During 1 month following the VTE hospitalization

External Links

•   BMS Clinical Trial Information
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•   Investigator Inquiry Form