Non-valvular Atrial FibrillationNCT03002740
Bleeding Events and Oral Anticoagulant Treatment in Non-Valvular Atrial Fibrillation
An observational study of Non-valvular Atrial Fibrillation, run by Bristol-Myers Squibb.
Trial summary
In a population of patients with non-valvular atrial fibrillation (NVAF), and treated with oral anticoagulants (OAC) in routine clinical practice in England, this study will describe patients treated with each OAC, and to estimate and compare event rates of treatment discontinuation, bleeding, and healthcare resource… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2016to 31 Aug 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: Adults with NVAF recorded in the UK Clinical Practice Research Datalink(CPRD) and Hospital Episode Statistics(HES) database, and who were newly prescribed with apixaban, rivaroxaban, dabigatran or VKA from 1st December 2012 and 31st December 2015 (or up to the most recent data available).
Who may be able to join
- Have a prescription for apixaban, rivaroxaban, dabigatran, or VKA during the study period
- Are ≥ 18 years of age at index date
- Have ≥ 12 months of computerised medical data prior to index date (date of OAC initiation)
- Have a record of AF on or ever prior to index date
Who cannot join
- Have a record for a valvular condition that is considered causal for AF on or ever prior to index date
- Have a history of the OACs which are prescribed during the study period (ie, history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran, or VKA)
- Have more than 1 OAC exposure which starts on the same date
About this study
Official title: Bleeding Events and Oral Anticoagulant Treatment in Non-Valvular Atrial Fibrillation (Heart-BEAT): A Cohort Study Based on CPRD-HES Data
In a population of patients with non-valvular atrial fibrillation (NVAF), and treated with oral anticoagulants (OAC) in routine clinical practice in England, this study will describe patients treated with each OAC, and to estimate and compare event rates of treatment discontinuation, bleeding, and healthcare resource utilisation (HCRU) across OAC treatments.
- Conditions
- Non-valvular Atrial Fibrillation
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 |
|---|---|---|
| NVAF patients newly prescribed apixaban | Not described | |
| NVAF patients newly prescribed rivaroxaban | Not described | |
| NVAF patients newly prescribed dabigatran | Not described | |
| NVAF patients newly prescribed VKA | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of clinically relevant bleeding events following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)
Measured: Approximately 3 years
Secondary outcomes (5)
Composite of clinical characteristics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)
Measured: At baseline
Composite of patient demographics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)
Measured: At baseline
Cumulative incidence of a major bleeding event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)
Measured: Approximately 3 years
Cumulative incidence of a thromboembolic event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)
Measured: Approximately 3 years
Composite of Healthcare resource utilization patients newly prescribed oral anticoagulants (OACs)
Healthcare resource utilization corresponds to referrals, hospitalizations, prescriptions, and laboratory tests
Measured: Approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study start31 Jan 2016
- Primary completion31 Aug 2018 (estimated)
- Study completion31 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-valvular 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002740
- Sponsor's protocol ID
- CV185-491
- Status last verified
- Sep 2018
- First submitted
- 21 Dec 2016
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding Events and Oral Anticoagulant Treatment in Non-Valvular Atrial Fibrillation (Heart-BEAT): A Cohort Study Based on CPRD-HES Data
- ClinicalTrials.gov ID
- NCT03002740
- Acronym / sponsor ID
- CV185-491
- Conditions
- Non-valvular Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 31 Jan 2016 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 26 Dec 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.
In a population of patients with non-valvular atrial fibrillation (NVAF), and treated with oral anticoagulants (OAC) in routine clinical practice in England, this study will describe patients treated with each OAC, and to estimate and compare event rates of treatment discontinuation, bleeding, and healthcare resource utilisation (HCRU) across OAC treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NVAF patients newly prescribed apixaban | – | – |
| NVAF patients newly prescribed rivaroxaban | – | – |
| NVAF patients newly prescribed dabigatran | – | – |
| NVAF patients newly prescribed VKA | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with NVAF recorded in the UK Clinical Practice Research Datalink(CPRD) and Hospital Episode Statistics(HES) database, and who were newly prescribed with apixaban, rivaroxaban, dabigatran or VKA from 1st December 2012 and 31st December 2015 (or up to the most recent data available).
Key inclusion criteria (4 listed)
- Have a prescription for apixaban, rivaroxaban, dabigatran, or VKA during the study period
- Are ≥ 18 years of age at index date
- Have ≥ 12 months of computerised medical data prior to index date (date of OAC initiation)
- Have a record of AF on or ever prior to index date
Key exclusion criteria (3 listed)
- Have a record for a valvular condition that is considered causal for AF on or ever prior to index date
- Have a history of the OACs which are prescribed during the study period (ie, history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran, or VKA)
- Have more than 1 OAC exposure which starts on the same date
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
Cumulative incidence of clinically relevant bleeding events following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)
Time frame: Approximately 3 years
5 secondary outcomes
Composite of clinical characteristics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)
Time frame: At baseline
Composite of patient demographics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)
Time frame: At baseline
Cumulative incidence of a major bleeding event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)
Time frame: Approximately 3 years
Cumulative incidence of a thromboembolic event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)
Time frame: Approximately 3 years
Composite of Healthcare resource utilization patients newly prescribed oral anticoagulants (OACs)
Time frame: Approximately 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- BMS Clinical Trial InformationLink provided by the sponsor.
Related trials for Non-valvular Atrial Fibrillation
Active, not recruiting
An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
Non-valvular Atrial Fibrillation
Active, not recruiting
CHAMPION-AF Clinical Trial
Atrial Fibrillation, Stroke
Not yet recruitingPhase 2
Vortosiran in Atrial Fibrillation
Non-valvular Atrial Fibrillation (AF)
Active, not recruitingObservational study
WATCHMAN FLX Pro European Registry
Non-valvular Atrial Fibrillation (AF), Left Atrial Appendage Closure
Active, not recruiting
LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation
Non Valvular Atrial Fibrillation
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 Non-valvular 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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 10 Oct 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 was withdrawn before enrolling participants, so there are no results.
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?
Cumulative incidence of clinically relevant bleeding events following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs) (time frame: Approximately 3 years). 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 10 Oct 2018.