Venous ThromboembolismNCT03087474
Treatment of Venous Thromboembolism in Real-Life Patients
An observational study of Venous Thromboembolism, run by Bristol-Myers Squibb.
Trial summary
In a population of patients with venous thromboembolism and treated with oral anticoagulants (OAC) in routine clinical practice in Denmark this study will describe patients treated with each OAC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Non-Interventional
- Type of treatment
- Pill or oral medicine
- How many people
- 89,383 participants
- Where
- No sites listed yet
- Study dates
- 4 Dec 2015to 28 Jun 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 Danish National Patient Registry (DNPR), covering all Danish hospitals, will be used to identify first-time and recurrent VTE cases diagnosed from 01-Jan-2006 through 31-Dec-2015.
Who may be able to join
- All patients ≥ 18 years diagnosed with incident VTE at Danish public hospitals from 2006 through 2015
- First-time (index) VTE will be defined as an in- or out-patient diagnosis of DVT or PE among patients redeeming a prescription for anticoagulant drugs within 30 days after index date
Who cannot join
- 1. In the analyses on type and duration of anticoagulant use, Patients with cancer will be excluded as they typically receive low molecular heparin directly from the hospital and their use of anticoagulants can therefore not be captured by redeemed prescriptions at pharmacies.
About this study
Official title: Treatment of Venous Thromboembolism in Real-Life Patients: A Nationwide, Population-Based Study
In a population of patients with venous thromboembolism and treated with oral anticoagulants (OAC) in routine clinical practice in Denmark this study will describe patients treated with each OAC
- Conditions
- Venous Thromboembolism
- Being tested
- Non-Interventional
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| VKA patients | Vitamin K antagonist (VKA) patients Receives: Other: Non-Interventional | |
| NOAC patients | nonvitamin K antagonist oral anticoagulants (NOAC) patients Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization rate in VKA patients for VTE
Hospitalization rate for first-time Venous thromboembolism (VTE) in Vitamin K antagonist (VKA) patients
Measured: Approximately 180 months
VTE hospitalization rate in VKA patients by sex
Measured: Approximately 180 months
VTE hospitalization rate in VKA patients by age
Measured: Approximately 180 months
Hospitalization rate in NOAC patients for VTE
Hospitalization rate for first-time venous thromboembolism in nonvitamin K antagonist oral anticoagulants (NOAC) patients
Measured: Approximately 180 months
VTE hospitalization rate in NOAC patients by sex
Measured: Approximately 180 months
VTE hospitalization rate in NOAC patients by age
Measured: Approximately 180 months
Duration of Treatment in NOAC patients
Measured: Approximately 180 months
Duration of treatment in VKA patients
Measured: Approximately 180 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start4 Dec 2015
- Primary completion31 Dec 2017
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies 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
- 89,383 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
- NCT03087474
- Sponsor's protocol ID
- CV185-496
- Status last verified
- Jul 2018
- First submitted
- 2 Mar 2017
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Venous Thromboembolism in Real-Life Patients: A Nationwide, Population-Based Study
- ClinicalTrials.gov ID
- NCT03087474
- Acronym / sponsor ID
- CV185-496
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89,383 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 22 Mar 2017 (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.
In a population of patients with venous thromboembolism and treated with oral anticoagulants (OAC) in routine clinical practice in Denmark this study will describe patients treated with each OAC
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VKA patients | – | Other: Non-InterventionalVitamin K antagonist (VKA) patients |
| NOAC patients | – | Other: Non-Interventionalnonvitamin K antagonist oral anticoagulants (NOAC) patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Danish National Patient Registry (DNPR), covering all Danish hospitals, will be used to identify first-time and recurrent VTE cases diagnosed from 01-Jan-2006 through 31-Dec-2015.
Key inclusion criteria (2 listed)
- All patients ≥ 18 years diagnosed with incident VTE at Danish public hospitals from 2006 through 2015
- First-time (index) VTE will be defined as an in- or out-patient diagnosis of DVT or PE among patients redeeming a prescription for anticoagulant drugs within 30 days after index date
Key exclusion criteria (1 listed)
- 1. In the analyses on type and duration of anticoagulant use, Patients with cancer will be excluded as they typically receive low molecular heparin directly from the hospital and their use of anticoagulants can therefore not be captured by redeemed prescriptions at pharmacies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | NOAC patients, VKA patients |
Primary outcome
Hospitalization rate in VKA patients for VTE
Time frame: Approximately 180 months
Hospitalization rate for first-time Venous thromboembolism (VTE) in Vitamin K antagonist (VKA) patients
VTE hospitalization rate in VKA patients by sex
Time frame: Approximately 180 months
VTE hospitalization rate in VKA patients by age
Time frame: Approximately 180 months
Hospitalization rate in NOAC patients for VTE
Time frame: Approximately 180 months
Hospitalization rate for first-time venous thromboembolism in nonvitamin K antagonist oral anticoagulants (NOAC) patients
VTE hospitalization rate in NOAC patients by sex
Time frame: Approximately 180 months
VTE hospitalization rate in NOAC patients by age
Time frame: Approximately 180 months
Duration of Treatment in NOAC patients
Time frame: Approximately 180 months
Duration of treatment in VKA patients
Time frame: Approximately 180 months
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 11 Jul 2018.
- BMS Clinical Trial InformationLink 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
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Bristol-Myers Squibb.
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 2 inclusion and 1 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 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Hospitalization rate in VKA patients for VTE (time frame: Approximately 180 months). The study lists 8 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 11 Jul 2018.