Atrial FibrillationEQUAL-AFNCT05044533
A Study Evaluating Quality of Life for Participants With Atrial Fibrillation (AF) Following a Bleed (EQUAL-AF)
An observational study of Atrial Fibrillation, run by Bristol-Myers Squibb at 1 site in United Kingdom.
Trial summary
The purpose of this observational study is to identify participants with both minor and major bleeds as a result of anticoagulant treatment for AF and evaluating their QoL through both primary and secondary care settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 May 2021to 9 Mar 2022
- 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: Adult patients (≥18) who have Atrial fibrillation (AF) and are actively prescribed oral anticoagulant therapies (OATs) and have recently experienced bleeds, up to a maximum of 30 days prior to enrolment. No upper age limit will be applied, but patients must match all other inclusion/exclusion criteria.
Who may be able to join
- Adult patients (>= 18 years old)
- Patients who can understand all study information and literature to provide fully informed consent
- Atrial fibrillation (AF) as the primary diagnosis
- Having a major or minor bleed up to a maximum of 30 days prior to point of enrolment
- Receiving oral anticoagulation therapy for AF
Who cannot join
- Pregnant women
- Patients with active cancer
- Patients unable to consent for themselves
- Patient on concomitant antiplatelet therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating QUAlity of Life of AF Patients Following a Bleed (EQUAL-AF)
The purpose of this observational study is to identify participants with both minor and major bleeds as a result of anticoagulant treatment for AF and evaluating their QoL through both primary and secondary care settings.
- Conditions
- Atrial Fibrillation
- Keywords
- BMS-562247, Atrial Fibrillation, Oral Anticoagulant, Prospective Study, Quality of Life (QoL), United Kingdom
- Medical subject headings
- 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 |
|---|---|---|
| Cohort 1 | Participants with atrial fibrillation (AF) experiencing a bleed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of characteristics of AF participants: Quality of life (QoL) data
Measured: Up to 90 days
Distribution of characteristics of AF participants: Impact of the anticoagulation treatment
Measured: Up to 90 days
Secondary outcomes (5)
Distribution of outcomes of AF participants: Timing of bleeding occurrence
Measured: Up to 90 days
Distribution of outcomes of AF participants: Nature of the bleed
Measured: Up to 90 days
Distribution of outcomes of AF participants: Current Bleeding treatment
Measured: Up to 90 days
Distribution of outcomes of AF participants: Location of bleed
Measured: Up to 90 days
Distribution of outcomes of AF participants: Documented cause of bleed
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start31 May 2021
- Primary completion9 Mar 2022
- Study completion9 Mar 2022
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
- Prospective
- Enrolment
- 50 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
- NCT05044533
- Sponsor's protocol ID
- CV185-770
- Acronym
- EQUAL-AF
- Status last verified
- Jun 2023
- First submitted
- 10 Sep 2021
- Last updated
- 18 Jun 2023
- 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 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating QUAlity of Life of AF Patients Following a Bleed (EQUAL-AF)
- ClinicalTrials.gov ID
- NCT05044533
- Acronym / sponsor ID
- EQUAL-AF / CV185-770
- Conditions
- Atrial Fibrillation
- Keywords
- BMS-562247, Atrial Fibrillation, Oral Anticoagulant, Prospective Study, Quality of Life (QoL), United Kingdom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 May 2021 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 14 Sep 2021 (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.
The purpose of this observational study is to identify participants with both minor and major bleeds as a result of anticoagulant treatment for AF and evaluating their QoL through both primary and secondary care settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants with atrial fibrillation (AF) experiencing a bleed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18) who have Atrial fibrillation (AF) and are actively prescribed oral anticoagulant therapies (OATs) and have recently experienced bleeds, up to a maximum of 30 days prior to enrolment. No upper age limit will be applied, but patients must match all other inclusion/exclusion criteria.
Key inclusion criteria (5 listed)
- Adult patients (>= 18 years old)
- Patients who can understand all study information and literature to provide fully informed consent
- Atrial fibrillation (AF) as the primary diagnosis
- Having a major or minor bleed up to a maximum of 30 days prior to point of enrolment
- Receiving oral anticoagulation therapy for AF
Key exclusion criteria (4 listed)
- Pregnant women
- Patients with active cancer
- Patients unable to consent for themselves
- Patient on concomitant antiplatelet therapy
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
Distribution of characteristics of AF participants: Quality of life (QoL) data
Time frame: Up to 90 days
Distribution of characteristics of AF participants: Impact of the anticoagulation treatment
Time frame: Up to 90 days
5 secondary outcomes
Distribution of outcomes of AF participants: Timing of bleeding occurrence
Time frame: Up to 90 days
Distribution of outcomes of AF participants: Nature of the bleed
Time frame: Up to 90 days
Distribution of outcomes of AF participants: Current Bleeding treatment
Time frame: Up to 90 days
Distribution of outcomes of AF participants: Location of bleed
Time frame: Up to 90 days
Distribution of outcomes of AF participants: Documented cause of bleed
Time frame: Up to 90 days
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 18 Jun 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink 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
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, run by Bristol-Myers Squibb at 1 site in United Kingdom.
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 4 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 18 Jun 2023. 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 Kingdom. 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?
Distribution of characteristics of AF participants: Quality of life (QoL) data (time frame: Up to 90 days). 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 18 Jun 2023.