Atrial FibrillationEQUAL-AFNCT04921176
Evaluating Quality of Life of AF Patients Following a Bleed
An observational study of Atrial Fibrillation, run by Swansea University at 3 sites in United Kingdom.
Trial summary
EQUAL-AF is an observational feasibility study which will determine if there is a long-term effect of bleeding for patients diagnosed with AF, who are taking anticoagulants. The investigators will use three validated questionnaires/PROMs (AFEQT, EQ5D-3L, and PACT-Q) to gather data from a patient perspective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 32 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 22 Dec 2020to 9 Mar 2022
- How long will I take part?
- 3 Months
- 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 AF are actively prescribed oral anticoagulant therapies (OATs) and have recently experienced bleeds, up to a maximum of 4 weeks prior to enrolment. No upper age limit will be applied, but patients must match all other inclusion/exclusion criteria. Patients will be selected from the Swansea area only, who attend/have attended either anticoagulation clinics within the Swansea City Health Cluster, Morriston emergency department or have been admitted to wards at Morriston Hospital due to a bleed.
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
3 sites in 1 country.
United Kingdom3 sites
Arrhythmia Alliance
Oxford, England, OX7 5SR
Morriston Hospital
Swansea, West Glamorgan, SA6 6NL
Swansea City GP Cluster
Swansea, West Glamorgan
About this study
EQUAL-AF is an observational feasibility study which will determine if there is a long-term effect of bleeding for patients diagnosed with AF, who are taking anticoagulants. The investigators will use three validated questionnaires/PROMs (AFEQT, EQ5D-3L, and PACT-Q) to gather data from a patient perspective. Patients will complete all questionnaires no more than 4 weeks following a bleed and a second time 3 months later. As this study tests feasibility, progression criteria will apply. The primary objective is to assess recruitment success to ensure that the patient population is accessible and willing to engage with the research team. Additionally, the investigators will look to identify the need for a specific bleeding PROM which will assess long-term quality of life impact for patients experiencing bleeds while anticoagulated.
- Conditions
- Atrial Fibrillation
- Keywords
- Quality of Life, Bleed events, Patient Reported Outcome Measure, Anticoagulation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Test the feasibility of identifying and recruiting patients with both minor and major bleeds as a result of anticoagulant treatment for AF associated events
Recruitment of a minimum of 50 eligible patients onto the study
Measured: Following 6 months recruitment window
Patient quality of life in both primary and secondary care settings as measured by EQ-5D-5L score
Patient quality of life in both primary and secondary care settings as measured by EQ-5D-
Measured: Within 4 weeks following bleed
Patient quality of life in both primary and secondary care settings as measured by EQ-5D-5L score
Patient quality of life in both primary and secondary care settings as measured by EQ-5D-
Measured: 3 months following first completion of study survey
Patient quality of life in both primary and secondary care settings as measured by Atrial Fibrillation Effect of Quality of Life score (AFEQT)
Patient quality of life in both primary and secondary care settings as measured by Atrial
Measured: Within 4 weeks following bleed
Patient quality of life in both primary and secondary care settings as measured by Atrial Fibrillation Effect of Quality of Life score (AFEQT)
Patient quality of life in both primary and secondary care settings as measured by Atrial
Measured: 3 months following first completion of study survey
Patient quality of life in both primary and secondary care settings as measured by Perception of Anticoagulant Treatment Questionnaire (PACT-Q)
Patient quality of life in both primary and secondary care settings as measured by
Measured: Within 4 weeks following bleed
Patient quality of life in both primary and secondary care settings as measured by Perception of Anticoagulant Treatment Questionnaire (PACT-Q)
Patient quality of life in both primary and secondary care settings as measured by
Measured: 3 months following first completion of study survey
Secondary outcomes (4)
Observe differences in QoL by type of bleed as measured by clinical classification of minor and major bleeds using BARC scale.
A small number of additional relevant questions will be asked of the patient, regarding when the bleed occurred, the nature of the bleed and their current treatment.
Measured: One data point at 4 weeks using the validated questionnaires and a follow-up at 3 months for each patient.
Identifying the treatment received and the nature of the bleed experienced by capturing type of anticoagulant combined with bleed details from each participant.
Identifying the treatment received and the nature of the bleed experienced by capturing
Measured: One data point at 4 weeks using the validated questionnaires and a follow-up at 3 months for each patient.
Insight into issues experienced with bleeding from participant perspective as measured by structured qualitative interviews.
Insight into issues experienced with bleeding from participant perspective as measured by structured qualitative interviews.
Measured: Following completion of both 4 week and 3 month timepoint.
Appropriateness of three chosen PROMs (EQ5D, AFEQT and PACT-Q, part 2) in capturing QoL data for patients who have experienced a bleed while anticoagulated as measured by responses to suitability questions within the participant survey.
Additional questions to evaluate appropriateness of chosen PROMs in capturing Quality of Life issues for patients diagnosed with AF who are anticoagulated
Measured: One data point at 4 weeks using the validated questionnaires and a follow-up at 3 months for each patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start22 Dec 2020
- 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.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 32 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Pfizer
- Responsible party
- Sponsor
- Investigators
- Hayley Hutchings, Principal investigator, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921176
- Sponsor's protocol ID
- 279646
- Acronym
- EQUAL-AF
- Status last verified
- Sep 2022
- First submitted
- 27 Jan 2021
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
PubMed 15189396Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.
PubMed 15842354Liu GJ, Wang YF, Chen PY, Chang W, Tu ML, Chang LY, Cheng P, Luo J. The efficacy and safety of novel oral anticoagulants for the preventive treatment in atrial fibrillation patients: a systematic review and meta-analysis. Drug Deliv. 2014 Sep;21(6):436-52. doi: 10.3109/10717544.2013.873500. Epub 2014 Jan 8.
PubMed 24400656Patel NJ, Atti V, Mitrani RD, Viles-Gonzalez JF, Goldberger JJ. Global rising trends of atrial fibrillation: a major public health concern. Heart. 2018 Dec;104(24):1989-1990. doi: 10.1136/heartjnl-2018-313350. Epub 2018 Jun 15. No abstract available.
PubMed 29907645Darby-Stewart A, Dachs R, Graber MA. Rivaroxaban vs. warfarin for stroke prevention in patients with nonvalvular atrial fibrillation. Am Fam Physician. 2012 Mar 15;85(6):577-86.
PubMed 22534269Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17.
PubMed 24345399Li X, Tse VC, Au-Doung LW, Wong ICK, Chan EW. The impact of ischaemic stroke on atrial fibrillation-related healthcare cost: a systematic review. Europace. 2017 Jun 1;19(6):937-947. doi: 10.1093/europace/euw093.
PubMed 27209573Lane DA, Skjoth F, Lip GYH, Larsen TB, Kotecha D. Temporal Trends in Incidence, Prevalence, and Mortality of Atrial Fibrillation in Primary Care. J Am Heart Assoc. 2017 Apr 28;6(5):e005155. doi: 10.1161/JAHA.116.005155.
PubMed 28455344Hansen PW, Sehested TSG, Fosbol EL, Torp-Pedersen C, Kober L, Andersson C, Gislason GH. Trends in warfarin use and its associations with thromboembolic and bleeding rates in a population with atrial fibrillation between 1996 and 2011. PLoS One. 2018 Mar 16;13(3):e0194295. doi: 10.1371/journal.pone.0194295. eCollection 2018.
PubMed 29547673Kannel WB, Wolf PA, Benjamin EJ, Levy D. Prevalence, incidence, prognosis, and predisposing conditions for atrial fibrillation: population-based estimates. Am J Cardiol. 1998 Oct 16;82(8A):2N-9N. doi: 10.1016/s0002-9149(98)00583-9.
PubMed 9809895Barra S, Fynn S. Untreated atrial fibrillation in the United Kingdom: Understanding the barriers and treatment options. J Saudi Heart Assoc. 2015 Jan;27(1):31-43. doi: 10.1016/j.jsha.2014.08.002. Epub 2014 Sep 3.
PubMed 25544820Montbleau KE, King D, Henault L, Magnani JW. Health literacy, health-related quality of life, and atrial fbrillation. Cogent Med. 2017;4:1412121. doi: 10.1080/2331205X.2017.1412121. Epub 2017 Dec 11.
PubMed 29276719Thrall G, Lane D, Carroll D, Lip GY. Quality of life in patients with atrial fibrillation: a systematic review. Am J Med. 2006 May;119(5):448.e1-19. doi: 10.1016/j.amjmed.2005.10.057.
PubMed 16651058Spertus J, Dorian P, Bubien R, Lewis S, Godejohn D, Reynolds MR, Lakkireddy DR, Wimmer AP, Bhandari A, Burk C. Development and validation of the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire in patients with atrial fibrillation. Circ Arrhythm Electrophysiol. 2011 Feb;4(1):15-25. doi: 10.1161/CIRCEP.110.958033. Epub 2010 Dec 15.
PubMed 21160035Hagens VE, Ranchor AV, Van Sonderen E, Bosker HA, Kamp O, Tijssen JG, Kingma JH, Crijns HJ, Van Gelder IC; RACE Study Group. Effect of rate or rhythm control on quality of life in persistent atrial fibrillation. Results from the Rate Control Versus Electrical Cardioversion (RACE) Study. J Am Coll Cardiol. 2004 Jan 21;43(2):241-7. doi: 10.1016/j.jacc.2003.08.037.
PubMed 14736444
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 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
- ClinicalTrials.gov ID
- NCT04921176
- Acronym / sponsor ID
- EQUAL-AF / 279646
- Conditions
- Atrial Fibrillation
- Keywords
- Quality of Life, Bleed events, Patient Reported Outcome Measure, Anticoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Pfizer
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 10 Jun 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.
EQUAL-AF is an observational feasibility study which will determine if there is a long-term effect of bleeding for patients diagnosed with AF, who are taking anticoagulants. The investigators will use three validated questionnaires/PROMs (AFEQT, EQ5D-3L, and PACT-Q) to gather data from a patient perspective. Patients will complete all questionnaires no more than 4 weeks following a bleed and a second time 3 months later. As this study tests feasibility, progression criteria will apply. The primary objective is to assess recruitment success to ensure that the patient population is accessible and willing to engage with the research team. Additionally, the investigators will look to identify the need for a specific bleeding PROM which will assess long-term quality of life impact for patients experiencing bleeds while anticoagulated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
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 AF are actively prescribed oral anticoagulant therapies (OATs) and have recently experienced bleeds, up to a maximum of 4 weeks prior to enrolment. No upper age limit will be applied, but patients must match all other inclusion/exclusion criteria. Patients will be selected from the Swansea area only, who attend/have attended either anticoagulation clinics within the Swansea City Health Cluster, Morriston emergency department or have been admitted to wards at Morriston Hospital due to a bleed.
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
Test the feasibility of identifying and recruiting patients with both minor and major bleeds as a result of anticoagulant treatment for AF associated events
Time frame: Following 6 months recruitment window
Recruitment of a minimum of 50 eligible patients onto the study
Patient quality of life in both primary and secondary care settings as measured by EQ-5D-5L score
Time frame: Within 4 weeks following bleed
Patient quality of life in both primary and secondary care settings as measured by EQ-5D-
Patient quality of life in both primary and secondary care settings as measured by EQ-5D-5L score
Time frame: 3 months following first completion of study survey
Patient quality of life in both primary and secondary care settings as measured by EQ-5D-
Patient quality of life in both primary and secondary care settings as measured by Atrial Fibrillation Effect of Quality of Life score (AFEQT)
Time frame: Within 4 weeks following bleed
Patient quality of life in both primary and secondary care settings as measured by Atrial
Patient quality of life in both primary and secondary care settings as measured by Atrial Fibrillation Effect of Quality of Life score (AFEQT)
Time frame: 3 months following first completion of study survey
Patient quality of life in both primary and secondary care settings as measured by Atrial
Patient quality of life in both primary and secondary care settings as measured by Perception of Anticoagulant Treatment Questionnaire (PACT-Q)
Time frame: Within 4 weeks following bleed
Patient quality of life in both primary and secondary care settings as measured by
Patient quality of life in both primary and secondary care settings as measured by Perception of Anticoagulant Treatment Questionnaire (PACT-Q)
Time frame: 3 months following first completion of study survey
Patient quality of life in both primary and secondary care settings as measured by
4 secondary outcomes
Observe differences in QoL by type of bleed as measured by clinical classification of minor and major bleeds using BARC scale.
Time frame: One data point at 4 weeks using the validated questionnaires and a follow-up at 3 months for each patient.
Identifying the treatment received and the nature of the bleed experienced by capturing type of anticoagulant combined with bleed details from each participant.
Time frame: One data point at 4 weeks using the validated questionnaires and a follow-up at 3 months for each patient.
Insight into issues experienced with bleeding from participant perspective as measured by structured qualitative interviews.
Time frame: Following completion of both 4 week and 3 month timepoint.
Appropriateness of three chosen PROMs (EQ5D, AFEQT and PACT-Q, part 2) in capturing QoL data for patients who have experienced a bleed while anticoagulated as measured by responses to suitability questions within the participant survey.
Time frame: One data point at 4 weeks using the validated questionnaires and a follow-up at 3 months for each patient.
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 28 Apr 2023.
- Background: PubMed 15189396Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
- Background: PubMed 15842354Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.
- Background: PubMed 24400656Liu GJ, Wang YF, Chen PY, Chang W, Tu ML, Chang LY, Cheng P, Luo J. The efficacy and safety of novel oral anticoagulants for the preventive treatment in atrial fibrillation patients: a systematic review and meta-analysis. Drug Deliv. 2014 Sep;21(6):436-52. doi: 10.3109/10717544.2013.873500. Epub 2014 Jan 8.
- Background: PubMed 29907645Patel NJ, Atti V, Mitrani RD, Viles-Gonzalez JF, Goldberger JJ. Global rising trends of atrial fibrillation: a major public health concern. Heart. 2018 Dec;104(24):1989-1990. doi: 10.1136/heartjnl-2018-313350. Epub 2018 Jun 15. No abstract available.
- Background: PubMed 22534269Darby-Stewart A, Dachs R, Graber MA. Rivaroxaban vs. warfarin for stroke prevention in patients with nonvalvular atrial fibrillation. Am Fam Physician. 2012 Mar 15;85(6):577-86.
- Background: PubMed 24345399Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17.
- Background: PubMed 27209573Li X, Tse VC, Au-Doung LW, Wong ICK, Chan EW. The impact of ischaemic stroke on atrial fibrillation-related healthcare cost: a systematic review. Europace. 2017 Jun 1;19(6):937-947. doi: 10.1093/europace/euw093.
- Background: PubMed 28455344Lane DA, Skjoth F, Lip GYH, Larsen TB, Kotecha D. Temporal Trends in Incidence, Prevalence, and Mortality of Atrial Fibrillation in Primary Care. J Am Heart Assoc. 2017 Apr 28;6(5):e005155. doi: 10.1161/JAHA.116.005155.
- Background: PubMed 29547673Hansen PW, Sehested TSG, Fosbol EL, Torp-Pedersen C, Kober L, Andersson C, Gislason GH. Trends in warfarin use and its associations with thromboembolic and bleeding rates in a population with atrial fibrillation between 1996 and 2011. PLoS One. 2018 Mar 16;13(3):e0194295. doi: 10.1371/journal.pone.0194295. eCollection 2018.
- Background: PubMed 9809895Kannel WB, Wolf PA, Benjamin EJ, Levy D. Prevalence, incidence, prognosis, and predisposing conditions for atrial fibrillation: population-based estimates. Am J Cardiol. 1998 Oct 16;82(8A):2N-9N. doi: 10.1016/s0002-9149(98)00583-9.
- Background: PubMed 25544820Barra S, Fynn S. Untreated atrial fibrillation in the United Kingdom: Understanding the barriers and treatment options. J Saudi Heart Assoc. 2015 Jan;27(1):31-43. doi: 10.1016/j.jsha.2014.08.002. Epub 2014 Sep 3.
- Background: PubMed 29276719Montbleau KE, King D, Henault L, Magnani JW. Health literacy, health-related quality of life, and atrial fbrillation. Cogent Med. 2017;4:1412121. doi: 10.1080/2331205X.2017.1412121. Epub 2017 Dec 11.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Hayley Hutchings principal investigator
Swansea University
3 sites 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 Swansea University at 3 sites 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 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Test the feasibility of identifying and recruiting patients with both minor and major bleeds as a result of anticoagulant treatment for AF associated events (time frame: Following 6 months recruitment window). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04921176, which also lists 33 linked publications.
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 28 Apr 2023.