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

October 24, 2019 updated by: Bristol-Myers Squibb

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

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Hospital Length of stay (LOS)
Time Frame: During the index hospitalization (Up to 30 days)
During the index hospitalization (Up to 30 days)
Hospital cost
Time Frame: During the index hospitalization (Up to 30 days)
During the index hospitalization (Up to 30 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of patients with major bleeding (MB)-related hospital readmissions
Time Frame: During 1 month after the index hospitalization
During 1 month after the index hospitalization
Proportion of patients with clinically relevant bleeding (CRB)-related hospital readmissions
Time Frame: During 1 month after the index hospitalization
During 1 month after the index hospitalization
Proportion of patients with any bleeding-related hospital readmissions
Time Frame: During 1 month after the index hospitalization
During 1 month after the index hospitalization
Proportion of patients with VTE-related hospital readmissions
Time Frame: During 1 month after the index hospitalization
During 1 month after the index hospitalization
Proportion of patients with combined VTE- or MB-related hospital readmissions
Time Frame: During 1 month after the index hospitalization
During 1 month after the index hospitalization
Proportion of patients with all-cause hospital readmissions
Time Frame: During 1 month after the index hospitalization
During 1 month after the index hospitalization
Hospital Length of stay (LOS) for major bleeding-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Hospital costs of readmissions for major bleeding-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Hospital charges of readmissions for major bleeding-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization]
During 1 month following the VTE hospitalization]
Mean number of hospital readmissions for major bleeding-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Hospital LOS for clinically relevant bleeding-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Hospital costs of readmissions for clinically relevant bleeding-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Hospital charges of readmissions for clinically relevant bleeding-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Mean number of hospital readmissions for clinically relevant bleeding-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Hospital LOS for any bleeding-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Hospital costs of readmissions for any bleeding-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Hospital charges of readmissions for any bleeding-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Mean number of hospital readmissions for any bleeding-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Hospital LOS for VTE-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Hospital costs of readmissions for VTE-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Hospital charges of readmissions for VTE-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Mean number of hospital readmissions for VTE-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Hospital LOS for combined VTE- or MB-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Hospital costs of readmissions for combined VTE- or MB-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Hospital charges of readmissions for combined VTE- or MB-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Mean number of hospital readmissions for combined VTE- or MB-related hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Hospital LOS for all-cause hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Hospital costs of readmissions for all-cause hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Hospital charges of readmissions for all-cause hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization
Mean number of hospital readmissions for all-cause hospital readmissions
Time Frame: During 1 month following the VTE hospitalization
During 1 month following the VTE hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 29, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CV185-589

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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