Venous Thromboembolism (VTE)NCT03521908
A Study to Compare the Risk of a Major Bleeding in Participants Who Received Blood Thinning Medications Following a Blood Clot
An observational study of Venous Thromboembolism (VTE), run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
A study to compare the risk of a major bleeding in participants who received 2 different blood thinning medications following a blood clot 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
- 35,756 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2016to 23 Nov 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 comprise all persons aged ≥18 years who received outpatient treatment with apixaban or warfarin within 30 days following their first observed encounter for VTE, and who met all other qualifying criteria.
Who may be able to join
- An acute-care inpatient encounter with a principal or secondarydiagnosis of VTE, or an ambulatory-care encounter with any diagnosis of VTE
- An outpatient pharmacy claim for apixaban or warfarin during the 30-day period following the index encounter
- Continuous and comprehensive medical/drug coverage for ≥6 months preceding the index encounter
Who cannot join
- Evidence of a trial fibrillation/flutter or chemotherapy/radiation therapy for malignancy (other than non-melanoma skin cancer) during 6-month period preceding first receipt of index therapy
- Evidence of VTE(VTE event)during 6-month period preceding index encounter
- Evidence of malignancy (other than non-melanoma skin cancer) during 90-day period preceding first receipt of index therapy
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk of Major Bleeding Associated With Apixaban Verses Warfarin in the Treatment of Venous Thromboembolism in US Clinical Practice
A study to compare the risk of a major bleeding in participants who received 2 different blood thinning medications following a blood clot
- 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 |
|---|---|---|
| Participants treated with apixaban | Not described | |
| Participants treated with warfarin | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major bleeding in participants treated with apixaban
Measured: 2 years
Incidence of major bleeding in participants treated with warfarin
Measured: 2 years
Secondary outcomes (4)
Incidence of clinically relevant non-major bleeding event in participants treated with apixaban
Measured: 2 years
Incidence of clinically relevant non-major bleeding event in participants treated with warfarin
Measured: 2 years
Incidence of recurrent VTE in participants treated with apixaban
Measured: 2 years
Incidence of recurrent VTE in participants treated with warfarin
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start13 Jun 2016
- Primary completion4 Jun 2018
- Study completion23 Nov 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
- 35,756 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
- NCT03521908
- Sponsor's protocol ID
- CV185-523
- Status last verified
- Feb 2022
- First submitted
- 30 Apr 2018
- Last updated
- 28 Feb 2022
- 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 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Major Bleeding Associated With Apixaban Verses Warfarin in the Treatment of Venous Thromboembolism in US Clinical Practice
- ClinicalTrials.gov ID
- NCT03521908
- Acronym / sponsor ID
- CV185-523
- Conditions
- Venous Thromboembolism (VTE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35,756 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2016 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 23 Nov 2018 (actual)
- First posted
- 11 May 2018 (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 to compare the risk of a major bleeding in participants who received 2 different blood thinning medications following a blood clot
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants treated with apixaban | – | – |
| Participants treated with warfarin | – | – |
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 comprise all persons aged ≥18 years who received outpatient treatment with apixaban or warfarin within 30 days following their first observed encounter for VTE, and who met all other qualifying criteria.
Key inclusion criteria (3 listed)
- An acute-care inpatient encounter with a principal or secondarydiagnosis of VTE, or an ambulatory-care encounter with any diagnosis of VTE
- An outpatient pharmacy claim for apixaban or warfarin during the 30-day period following the index encounter
- Continuous and comprehensive medical/drug coverage for ≥6 months preceding the index encounter
Key exclusion criteria (4 listed)
- Evidence of a trial fibrillation/flutter or chemotherapy/radiation therapy for malignancy (other than non-melanoma skin cancer) during 6-month period preceding first receipt of index therapy
- Evidence of VTE(VTE event)during 6-month period preceding index encounter
- Evidence of malignancy (other than non-melanoma skin cancer) during 90-day period preceding first receipt of index therapy
- 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
Incidence of major bleeding in participants treated with apixaban
Time frame: 2 years
Incidence of major bleeding in participants treated with warfarin
Time frame: 2 years
4 secondary outcomes
Incidence of clinically relevant non-major bleeding event in participants treated with apixaban
Time frame: 2 years
Incidence of clinically relevant non-major bleeding event in participants treated with warfarin
Time frame: 2 years
Incidence of recurrent VTE in participants treated with apixaban
Time frame: 2 years
Incidence of recurrent VTE in participants treated with warfarin
Time frame: 2 years
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 Feb 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink 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 4 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 Feb 2022. 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?
Incidence of major bleeding in participants treated with apixaban (time frame: 2 years). 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 Feb 2022.