Venous Thromboembolism (VTE)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
An observational study of Venous Thromboembolism (VTE), run by Bristol-Myers Squibb at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism (VTE)
- How many people
- 28,000 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2016to 31 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
- Conditions
- Venous Thromboembolism (VTE)
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of stay (LOS)
Measured: During the index hospitalization (Up to 30 days)
Hospital cost
Measured: During the index hospitalization (Up to 30 days)
Secondary outcomes (30)
Proportion of patients with major bleeding (MB)-related hospital readmissions
Measured: During 1 month after the index hospitalization
Proportion of patients with clinically relevant bleeding (CRB)-related hospital readmissions
Measured: During 1 month after the index hospitalization
Proportion of patients with any bleeding-related hospital readmissions
Measured: During 1 month after the index hospitalization
Proportion of patients with VTE-related hospital readmissions
Measured: During 1 month after the index hospitalization
Proportion of patients with combined VTE- or MB-related hospital readmissions
Measured: During 1 month after the index hospitalization
Proportion of patients with all-cause hospital readmissions
Measured: During 1 month after the index hospitalization
Hospital Length of stay (LOS) for major bleeding-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Hospital costs of readmissions for major bleeding-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Hospital charges of readmissions for major bleeding-related hospital readmissions
Measured: During 1 month following the VTE hospitalization]
Mean number of hospital readmissions for major bleeding-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Hospital LOS for clinically relevant bleeding-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Hospital costs of readmissions for clinically relevant bleeding-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Hospital charges of readmissions for clinically relevant bleeding-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Mean number of hospital readmissions for clinically relevant bleeding-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Hospital LOS for any bleeding-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Hospital costs of readmissions for any bleeding-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Hospital charges of readmissions for any bleeding-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Mean number of hospital readmissions for any bleeding-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Hospital LOS for VTE-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Hospital costs of readmissions for VTE-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Hospital charges of readmissions for VTE-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Mean number of hospital readmissions for VTE-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Hospital LOS for combined VTE- or MB-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Hospital costs of readmissions for combined VTE- or MB-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Hospital charges of readmissions for combined VTE- or MB-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Mean number of hospital readmissions for combined VTE- or MB-related hospital readmissions
Measured: During 1 month following the VTE hospitalization
Hospital LOS for all-cause hospital readmissions
Measured: During 1 month following the VTE hospitalization
Hospital costs of readmissions for all-cause hospital readmissions
Measured: During 1 month following the VTE hospitalization
Hospital charges of readmissions for all-cause hospital readmissions
Measured: During 1 month following the VTE hospitalization
Mean number of hospital readmissions for all-cause hospital readmissions
Measured: During 1 month following the VTE hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start29 Nov 2016
- Primary completion30 Apr 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolism (VTE)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 28,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141228
- Sponsor's protocol ID
- CV185-589
- Status last verified
- Oct 2019
- First submitted
- 21 Oct 2019
- Last updated
- 28 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hospital Healthcare Utilization and Costs Among Hospitalized Venous Thromboembolism (VTE) Patients Treated With Apixaban or Warfarin in the United States
- ClinicalTrials.gov ID
- NCT04141228
- Acronym / sponsor ID
- CV185-589
- Conditions
- Venous Thromboembolism (VTE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28,000 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital Length of stay (LOS)
Time frame: During the index hospitalization (Up to 30 days)
Hospital cost
Time frame: During the index hospitalization (Up to 30 days)
30 secondary outcomes
Proportion of patients with major bleeding (MB)-related hospital readmissions
Time frame: 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
Proportion of patients with any bleeding-related hospital readmissions
Time frame: During 1 month after the index hospitalization
Proportion of patients with VTE-related hospital readmissions
Time frame: 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
Proportion of patients with all-cause hospital readmissions
Time frame: 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
Hospital costs of readmissions for major bleeding-related hospital readmissions
Time frame: 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]
Mean number of hospital readmissions for major bleeding-related hospital readmissions
Time frame: 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
Hospital costs of readmissions for clinically relevant bleeding-related hospital readmissions
Time frame: 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
Mean number of hospital readmissions for clinically relevant bleeding-related hospital readmissions
Time frame: During 1 month following the VTE hospitalization
Hospital LOS for any bleeding-related hospital readmissions
Time frame: 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
Hospital charges of readmissions for any bleeding-related hospital readmissions
Time frame: 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
Hospital LOS for VTE-related hospital readmissions
Time frame: 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
Hospital charges of readmissions for VTE-related hospital readmissions
Time frame: 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
Hospital LOS for combined VTE- or MB-related hospital readmissions
Time frame: 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
Hospital charges of readmissions for combined VTE- or MB-related hospital readmissions
Time frame: 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
Hospital LOS for all-cause hospital readmissions
Time frame: 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
Hospital charges of readmissions for all-cause hospital readmissions
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism (VTE), run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Length of stay (LOS) (time frame: During the index hospitalization (Up to 30 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2019.