Atrial FibrillationNCT02792335
Oral Anticoagulant Discontinuation, Adherence Patterns, Hospitalizations and Costs in Non-Valvular Atrial Fibrillation (NVAF) Patients
An observational study of Atrial Fibrillation, run by Bristol-Myers Squibb.
Trial summary
To describe the rate of discontinuation among Non-Valvular Atrial Fibrillation (NVAF) patients who were on warfarin and have switched to the Novel oral anticoagulants(NOACs). 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?
- apixaban, dabigatran and rivaroxaban
- Type of treatment
- Pill or oral medicine
- How many people
- 28,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Aug 2014
- 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 initial study population will include Non-valvular atrial fibrillation (NVAF) patients who initiated warfarin or Novel oral anticoagulants (NOACs) between January 01, 2012 and August 31, 2014. The date of the first NOAC prescription claim during the enrollment period will serve as the index date. The patients who have at least 1 year of baseline data available will be included in the study.
Who may be able to join
- Individuals with NVAF who were on warfarin and have switched to the NOACs (dabigatran, rivaroxaban and apixaban) within the study period January 01, 2013 through March 31, 2014
- Individuals ≥18 years old on the index date
- At least 1 year of baseline period with history of continuous warfarin use in the baseline period for at least 3 months immediately before the index date
- At least 1 diagnosis of AF in the 12 months prior to index date
- Continuous eligibility with medical and pharmacy benefits for at least 12 months before the index date through 1 month after the index date
Who cannot join
- Individuals with a diagnosis of valvular heart disease or cardiac surgery during the 12 months prior to index date
About this study
Official title: Oral Anticoagulant Bleeding Rate and Discontinuation and Adherence Patterns in Non-Valvular Atrial Fibrillation (NVAF) Patients
To describe the rate of discontinuation among Non-Valvular Atrial Fibrillation (NVAF) patients who were on warfarin and have switched to the Novel oral anticoagulants(NOACs).
- Conditions
- Atrial Fibrillation
- Being tested
- apixaban, dabigatran, rivaroxaban, warfarin
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apixabanDrug
dabigatranDrug
rivaroxabanDrug
warfarinDrug
| Study group | Role | What they receive |
|---|---|---|
| patients naive to oral anticoagulant treatment | NVAF patients naïve to oral anticoagulant treatment (Naïve) Receives: Drug: apixaban; Drug: dabigatran; Drug: rivaroxaban | |
| patients with prior warfarin therapy | NVAF patients with prior warfarin therapy (Warfarin treated) Receives: Drug: apixaban; Drug: dabigatran; Drug: rivaroxaban; Drug: warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discontinuation rate of patients with prior warfarin use
Measured: up to 31 months
Rate of major bleeding events of patients with prior warfarin use
Measured: up to 31 months
Rate of hospitalization due to major bleeding events of patients with warfarin use
Measured: up to 31 months
Discontinuation rate of patients who were naïve to oral anticoagulant
Measured: up to 31 months
Rate of major bleeding events of patients who were naïve to oral anticoagulant
Measured: up to 31 months
Rate of hospitalization due to major bleeding events of patients who were naïve to oral anticoagulant
Measured: up to 31 months
Secondary outcomes (8)
Rate of All-Cause Hospitalization
Measured: up to 31 months
Rate of Atrial Fibrillation(AF)-Related Hospitalization
Measured: up to 31 months
Rate of All-Cause Any Rehospitalization
Measured: up to 31 months
Rate of AF-Related Any Rehospitalization
Measured: up to 31 months
Rate of All-Cause Early Hospitalization
Measured: up to 31 months
Rate of AF-Related Early Hospitalization
Measured: up to 31 months
All-Cause Healthcare per patient per month (PPPM) cost
Measured: up to 31 months
AF-related Healthcare per patient per month (PPPM) cost
Measured: up to 31 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startJan 2012
- Primary completionAug 2014
- Study completionAug 2014
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
- 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
- NCT02792335
- Sponsor's protocol ID
- CV185-412
- Status last verified
- Jun 2016
- First submitted
- 2 Jun 2016
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Anticoagulant Bleeding Rate and Discontinuation and Adherence Patterns in Non-Valvular Atrial Fibrillation (NVAF) Patients
- ClinicalTrials.gov ID
- NCT02792335
- Acronym / sponsor ID
- CV185-412
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28,000 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 7 Jun 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.
To describe the rate of discontinuation among Non-Valvular Atrial Fibrillation (NVAF) patients who were on warfarin and have switched to the Novel oral anticoagulants(NOACs).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients naive to oral anticoagulant treatment | – | Drug: apixaban, Drug: dabigatran, Drug: rivaroxabanNVAF patients naïve to oral anticoagulant treatment (Naïve) |
| patients with prior warfarin therapy | – | Drug: apixaban, Drug: dabigatran, Drug: rivaroxaban, Drug: warfarinNVAF patients with prior warfarin therapy (Warfarin treated) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The initial study population will include Non-valvular atrial fibrillation (NVAF) patients who initiated warfarin or Novel oral anticoagulants (NOACs) between January 01, 2012 and August 31, 2014. The date of the first NOAC prescription claim during the enrollment period will serve as the index date. The patients who have at least 1 year of baseline data available will be included in the study.
Key inclusion criteria (5 listed)
- Individuals with NVAF who were on warfarin and have switched to the NOACs (dabigatran, rivaroxaban and apixaban) within the study period January 01, 2013 through March 31, 2014
- Individuals ≥18 years old on the index date
- At least 1 year of baseline period with history of continuous warfarin use in the baseline period for at least 3 months immediately before the index date
- At least 1 diagnosis of AF in the 12 months prior to index date
- Continuous eligibility with medical and pharmacy benefits for at least 12 months before the index date through 1 month after the index date
Key exclusion criteria (1 listed)
- Individuals with a diagnosis of valvular heart disease or cardiac surgery during the 12 months prior to index date
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 |
|---|---|---|
| apixaban | Drug | patients naive to oral anticoagulant treatment, patients with prior warfarin therapy |
| dabigatran | Drug | patients naive to oral anticoagulant treatment, patients with prior warfarin therapy |
| rivaroxaban | Drug | patients naive to oral anticoagulant treatment, patients with prior warfarin therapy |
| warfarin | Drug | patients with prior warfarin therapy |
Primary outcome
Discontinuation rate of patients with prior warfarin use
Time frame: up to 31 months
Rate of major bleeding events of patients with prior warfarin use
Time frame: up to 31 months
Rate of hospitalization due to major bleeding events of patients with warfarin use
Time frame: up to 31 months
Discontinuation rate of patients who were naïve to oral anticoagulant
Time frame: up to 31 months
Rate of major bleeding events of patients who were naïve to oral anticoagulant
Time frame: up to 31 months
Rate of hospitalization due to major bleeding events of patients who were naïve to oral anticoagulant
Time frame: up to 31 months
8 secondary outcomes
Rate of All-Cause Hospitalization
Time frame: up to 31 months
Rate of Atrial Fibrillation(AF)-Related Hospitalization
Time frame: up to 31 months
Rate of All-Cause Any Rehospitalization
Time frame: up to 31 months
Rate of AF-Related Any Rehospitalization
Time frame: up to 31 months
Rate of All-Cause Early Hospitalization
Time frame: up to 31 months
Rate of AF-Related Early Hospitalization
Time frame: up to 31 months
All-Cause Healthcare per patient per month (PPPM) cost
Time frame: up to 31 months
AF-related Healthcare per patient per month (PPPM) cost
Time frame: up to 31 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 7 Jun 2016.
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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 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 5 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 7 Jun 2016. 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?
Discontinuation rate of patients with prior warfarin use (time frame: up to 31 months). The study lists 6 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 7 Jun 2016.