Atrial FibrillationNCT03508271
Effectiveness of Oral Anticoagulants in Elderly Patients With Non-Valvular Atrial Fibrillation and Heart Failure
An observational study of Atrial Fibrillation and Heart Failure, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
Observational study of elderly individuals diagnosed with Non-Valvular Atrial Fibrillation and Heart Failure who are beginning oral blood thinners Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation, Heart Failure
- What is being tested?
- Non-Interventional
- How many people
- 60,000 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2017to 8 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly individuals diagnosed with NVAF (non-valvular atrial fibrillation) and HF (heart failure) who are new initiators of DOAC's (direct oral anticoagulants)
Who may be able to join
- Were age greater than or equal to 65 years as of the index date
- Had greater than or equal to 1 diagnosis of AF prior to or on the index date
- Had greater than or equal to 1 diagnosis claim of HF during the 12 months prior to or on the index date
- Had 1 or more pharmacy claim for oral blood thinners
Who cannot join
- Claims indicating diagnosis or procedure for hip/knee replacement surgery within 6 weeks prior to index date
- Pharmacy claim for warfarin, apixaban, dabigatran, edoxaban or rivaroxaban during the 12-month baseline period
- Greater than 1 oral anticoagulants prescription claim on the index date and/or with a follow-up less than 1 day
- Had medical claim indicating VTE in the 12 months prior to index date
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-World Comparative Effectiveness Research Among Elderly Non-valvular Atrial Fibrillation (NVAF) Patients With Heart Failure (HF) Using Oral Anticoagulants
Observational study of elderly individuals diagnosed with Non-Valvular Atrial Fibrillation and Heart Failure who are beginning oral blood thinners
- Conditions
- Atrial Fibrillation, Heart Failure
- Being tested
- Non-Interventional
- Medical subject headings
- Atrial Fibrillation, Heart Failure
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 |
|---|---|---|
| Elderly individuals with NVAF and HF who are taking OAC's | Not described Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of stroke/systemic embolism (SE)
Measured: Approximately 195 weeks
Incidence of major bleeding
Measured: Approximately 195 weeks
Secondary outcomes (4)
Incidence of miocardial infarction (MI)
Measured: Approximately 195 weeks
Incidence of all cause mortality
Measured: Approximately 195 weeks
Incidence of all cause hospitalization
Measured: Approximately 195 weeks
Incidence of major adverse cardiac event
Measured: Approximately 195 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start30 Nov 2017
- Primary completion8 Nov 2018
- Study completion8 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- 60,000 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
- NCT03508271
- Sponsor's protocol ID
- CV185-681
- Status last verified
- Jan 2019
- First submitted
- 16 Apr 2018
- Last updated
- 4 Jan 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 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Comparative Effectiveness Research Among Elderly Non-valvular Atrial Fibrillation (NVAF) Patients With Heart Failure (HF) Using Oral Anticoagulants
- ClinicalTrials.gov ID
- NCT03508271
- Acronym / sponsor ID
- CV185-681
- Conditions
- Atrial Fibrillation, Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60,000 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 8 Nov 2018 (actual)
- First posted
- 25 Apr 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.
Observational study of elderly individuals diagnosed with Non-Valvular Atrial Fibrillation and Heart Failure who are beginning oral blood thinners
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly individuals with NVAF and HF who are taking OAC's | – | Other: Non-Interventional |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly individuals diagnosed with NVAF (non-valvular atrial fibrillation) and HF (heart failure) who are new initiators of DOAC's (direct oral anticoagulants)
Key inclusion criteria (4 listed)
- Were age greater than or equal to 65 years as of the index date
- Had greater than or equal to 1 diagnosis of AF prior to or on the index date
- Had greater than or equal to 1 diagnosis claim of HF during the 12 months prior to or on the index date
- Had 1 or more pharmacy claim for oral blood thinners
Key exclusion criteria (5 listed)
- Claims indicating diagnosis or procedure for hip/knee replacement surgery within 6 weeks prior to index date
- Pharmacy claim for warfarin, apixaban, dabigatran, edoxaban or rivaroxaban during the 12-month baseline period
- Greater than 1 oral anticoagulants prescription claim on the index date and/or with a follow-up less than 1 day
- Had medical claim indicating VTE in the 12 months prior to index date
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | Elderly individuals with NVAF and HF who are taking OAC's |
Primary outcome
Incidence of stroke/systemic embolism (SE)
Time frame: Approximately 195 weeks
Incidence of major bleeding
Time frame: Approximately 195 weeks
4 secondary outcomes
Incidence of miocardial infarction (MI)
Time frame: Approximately 195 weeks
Incidence of all cause mortality
Time frame: Approximately 195 weeks
Incidence of all cause hospitalization
Time frame: Approximately 195 weeks
Incidence of major adverse cardiac event
Time frame: Approximately 195 weeks
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 4 Jan 2019.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Atrial Fibrillation (AF)
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 Atrial Fibrillation and Heart Failure, 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 4 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 4 Jan 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?
Incidence of stroke/systemic embolism (SE) (time frame: Approximately 195 weeks). 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 4 Jan 2019.