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

NCT04141228 | Completed

• 1 other identifier: CV185-589
• Study Type: observational
• Target: 28,000
• Locations: 1 country
• Sites: 1

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)

Conditions

Venous Thromboembolism (VTE)

Outcome Measures

Primary Outcomes (2)

• Hospital Length of stay (LOS)

  During the index hospitalization (Up to 30 days)

• Hospital cost

  During the index hospitalization (Up to 30 days)

Secondary Outcomes (30)

• Proportion of patients with major bleeding (MB)-related hospital readmissions

  During 1 month after the index hospitalization

• Proportion of patients with clinically relevant bleeding (CRB)-related hospital readmissions

  During 1 month after the index hospitalization

• Proportion of patients with any bleeding-related hospital readmissions

  During 1 month after the index hospitalization

• Proportion of patients with VTE-related hospital readmissions

  During 1 month after the index hospitalization

• Proportion of patients with combined VTE- or MB-related hospital readmissions

  During 1 month after the index hospitalization

Study Arms (2)

Patients receiving apixaban

With or without low molecular weight heparin in the inpatient/emergency department (ED) setting

Patients receiving warfarin

With or without low molecular weight heparin in the inpatient/emergency department (ED) setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Flemington, New Jersey, 08822, United States

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 28, 2019
• Study Start: November 29, 2016
• Primary Completion: April 30, 2018
• Study Completion: May 31, 2018
• Last Updated: October 28, 2019

Record last verified: 2019-10

Locations

US (1)