Atrial FibrillationNCT02754154
Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants
An observational study of Atrial Fibrillation, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to compare the risk of major bleeding event among nonvalvular atrial fibrillation patients treated with warfarin, apixaban, dabigatran and rivaroxaban. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Warfarin, Apixaban and Dabigatran
- How many people
- 321,182 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2014to 26 Dec 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: Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using oral anticoagulants
Who may be able to join
- Patients ≥18 years old as of the index date
- At least 1 diagnosis of atrial fibrillation in the 12 months prior to or on index date, identified by any medical claim
- At least one year of baseline period and continuous enrollment for at least 12 months prior to index date Individuals with NVAF who were using oral anticoagulants (i.e., warfarin, dabigatran, rivaroxaban and apixaban) within the study period beginning Jan 1, 2012 through December 31, 2013 or last date of the last data cut available at the time of execution of the study
Who cannot join
- Patients with evidence of valvular heart disease, thyrotoxicosis, pericarditis, mitral stenosis, Venous thromboembolism(VTE), heart surgery, and endocarditis during the baseline period any time prior to or on index date
- Patients with any evidence of pregnancy at any time during the baseline will be excluded
About this study
The purpose of this study is to compare the risk of major bleeding event among nonvalvular atrial fibrillation patients treated with warfarin, apixaban, dabigatran and rivaroxaban.
- Conditions
- Atrial Fibrillation
- Being tested
- Warfarin, Apixaban, Dabigatran, Rivaroxaban
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
ApixabanDrug
DabigatranDrug
RivaroxabanDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients using Warfarin | Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Warfarin Receives: Drug: Warfarin | |
| Patients using Apixaban | Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Apixaban Receives: Drug: Apixaban | |
| Patients using Dabigatran | Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Dabigatran Receives: Drug: Dabigatran | |
| Patients using Rivaroxaban | Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Rivaroxaban Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to "First Major" Bleeding event
Measured: Up to 25 months
Secondary outcomes (5)
Time to "First Any" Bleeding event
Measured: Up to 25 months
Major Bleeding-Related Healthcare Utilization
(Number of Hospitalizations, Total Length of Hospital Stay (days), Time to Hospitalization, Number Of Emergency Room (ER) visits, and Number of Outpatient Visits with at least 1 major bleeding event )
Measured: Up to 25 months
Any Bleeding-Related Healthcare Utilization
(Number of Hospitalizations, Total Length of Hospital Stay (days), Time to Hospitalization, Number Of Emergency Room (ER) visits, and Number of Outpatient Visits with at least 1 bleeding event )
Measured: Up to 25 months
Major Bleeding-Related direct medical cost
(Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 major bleeding event)
Measured: Up to 25 months
Any Bleeding-Related direct medical cost
(Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 bleeding event)
Measured: Up to 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start31 Dec 2014
- Primary completion26 Dec 2018
- Study completion26 Dec 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
- 321,182 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
- NCT02754154
- Sponsor's protocol ID
- CV185-433
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2016
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants
- ClinicalTrials.gov ID
- NCT02754154
- Acronym / sponsor ID
- CV185-433
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321,182 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2014 (actual)
- Primary completion
- 26 Dec 2018 (actual)
- Study completion
- 26 Dec 2018 (actual)
- First posted
- 28 Apr 2016 (estimated)
- 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.
The purpose of this study is to compare the risk of major bleeding event among nonvalvular atrial fibrillation patients treated with warfarin, apixaban, dabigatran and rivaroxaban.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients using Warfarin | – | Drug: WarfarinPatients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Warfarin |
| Patients using Apixaban | – | Drug: ApixabanPatients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Apixaban |
| Patients using Dabigatran | – | Drug: DabigatranPatients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Dabigatran |
| Patients using Rivaroxaban | – | Drug: RivaroxabanPatients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Rivaroxaban |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using oral anticoagulants
Key inclusion criteria (3 listed)
- Patients ≥18 years old as of the index date
- At least 1 diagnosis of atrial fibrillation in the 12 months prior to or on index date, identified by any medical claim
- At least one year of baseline period and continuous enrollment for at least 12 months prior to index date Individuals with NVAF who were using oral anticoagulants (i.e., warfarin, dabigatran, rivaroxaban and apixaban) within the study period beginning Jan 1, 2012 through December 31, 2013 or last date of the last data cut available at the time of execution of the study
Key exclusion criteria (2 listed)
- Patients with evidence of valvular heart disease, thyrotoxicosis, pericarditis, mitral stenosis, Venous thromboembolism(VTE), heart surgery, and endocarditis during the baseline period any time prior to or on index date
- Patients with any evidence of pregnancy at any time during the baseline will be excluded
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 |
|---|---|---|
| Warfarin | Drug | Patients using Warfarin |
| Apixaban | Drug | Patients using Apixaban |
| Dabigatran | Drug | Patients using Dabigatran |
| Rivaroxaban | Drug | Patients using Rivaroxaban |
Primary outcome
Time to "First Major" Bleeding event
Time frame: Up to 25 months
5 secondary outcomes
Time to "First Any" Bleeding event
Time frame: Up to 25 months
Major Bleeding-Related Healthcare Utilization
Time frame: Up to 25 months
Any Bleeding-Related Healthcare Utilization
Time frame: Up to 25 months
Major Bleeding-Related direct medical cost
Time frame: Up to 25 months
Any Bleeding-Related direct medical cost
Time frame: Up to 25 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 9 May 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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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, 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
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, 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 3 inclusion and 2 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 9 May 2022. 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?
Time to "First Major" Bleeding event (time frame: Up to 25 months). 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 9 May 2022.