Clinical trial NCT04141228: 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
Official title: Evaluation of Hospital Healthcare Utilization and Costs Among Hospitalized Venous Thromboembolism (VTE) Patients Treated With Apixaban or Warfarin in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism (VTE)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-10-28
Enrollment: 28000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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)


Eligibility criteria: 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

Primary outcomes:
measure: Hospital Length of stay (LOS)
timeFrame: During the index hospitalization (Up to 30 days)
measure: Hospital cost
timeFrame: During the index hospitalization (Up to 30 days)
Secondary outcomes:
measure: Proportion of patients with major bleeding (MB)-related hospital readmissions
timeFrame: During 1 month after the index hospitalization
measure: Proportion of patients with clinically relevant bleeding (CRB)-related hospital readmissions
timeFrame: During 1 month after the index hospitalization
measure: Proportion of patients with any bleeding-related hospital readmissions
timeFrame: During 1 month after the index hospitalization
measure: Proportion of patients with VTE-related hospital readmissions
timeFrame: During 1 month after the index hospitalization
measure: Proportion of patients with combined VTE- or MB-related hospital readmissions
timeFrame: During 1 month after the index hospitalization
measure: Proportion of patients with all-cause hospital readmissions
timeFrame: During 1 month after the index hospitalization
measure: Hospital Length of stay (LOS) for major bleeding-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Hospital costs of readmissions for major bleeding-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Hospital charges of readmissions for major bleeding-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization]
measure: Mean number of hospital readmissions for major bleeding-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Hospital LOS for clinically relevant bleeding-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Hospital costs of readmissions for clinically relevant bleeding-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Hospital charges of readmissions for clinically relevant bleeding-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Mean number of hospital readmissions for clinically relevant bleeding-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Hospital LOS for any bleeding-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Hospital costs of readmissions for any bleeding-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Hospital charges of readmissions for any bleeding-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Mean number of hospital readmissions for any bleeding-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Hospital LOS for VTE-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Hospital costs of readmissions for VTE-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Hospital charges of readmissions for VTE-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Mean number of hospital readmissions for VTE-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Hospital LOS for combined VTE- or MB-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Hospital costs of readmissions for combined VTE- or MB-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Hospital charges of readmissions for combined VTE- or MB-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Mean number of hospital readmissions for combined VTE- or MB-related hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Hospital LOS for all-cause hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Hospital costs of readmissions for all-cause hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Hospital charges of readmissions for all-cause hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
measure: Mean number of hospital readmissions for all-cause hospital readmissions
timeFrame: During 1 month following the VTE hospitalization
Other outcomes:
Locations:
city: Flemington
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: