Atrial FibrillationPhase 4DaRe2THINKNCT04700826
Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation
A Phase 4 study testing Direct Oral Anticoagulants in people with Atrial Fibrillation, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
The DaRe2 approach (healthcare Data for pragmatic clinical Research in the NHS - primary 2 secondary) is designed to operationalise efficient, nationwide, primary care approaches for randomised trials embedded within the UK National Health Service (NHS), providing automated screening, targeted patient enrolment and… Read more about this study
- Who is it for?
- Ages 55 to 73 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Direct Oral Anticoagulants
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2021to Jan 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 55 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of AF (previous, current or chronic)
- Age at enrolment ≥55 years to ≤73 years
Who cannot join
- Prior documented stroke, transient ischaemic attack or systemic thromboembolism.
- Combination of multiple known risk factors for stroke where oral anticoagulation would ordinarily be started, including: Heart failure; Hypertension; Age 65 years or older; Diabetes mellitus; Previous myocardial infarction, peripheral artery disease or aortic plaque; and/or Female gender.
- Any prior history of intracranial bleeding.
- Prior major bleeding requiring hospitalisation in the last 3 years.
- Condition that poses a significant risk for bleeding (within 12 months) including gastrointestinal ulceration, brain/spinal/ophthalmic injury or surgery, arteriovenous malformations or vascular aneurysms, major intraspinal or intracerebral vascular abnormalities, hepatic disease associated with coagulopathy, known or suspected oesophageal varices, and cancers with high bleeding risk.
- Estimated glomerular filtration rate <30 mL/min/1.73m2 measured within the last 12 months.
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- Patients receiving systemic treatment with azole-antimycotics within the last 3 months (ketoconazole, itraconazole, voriconazole and posaconazole).
- Documented diagnosis of dementia.
- Hypersensitivity or known intolerance to direct oral anticoagulants.
- Currently receiving an anticoagulant.
- Any clinical indication for anticoagulation.
- Active clinically-significant bleeding.
- Life expectancy estimated <2 years.
- Participant unable or unwilling to provide informed consent for access and linkage of past and future electronic healthcare records.
- Currently participating in another clinical trial.
- Women of childbearing potential.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Birmingham
Birmingham, West Midlands, B15 2TH
Minnie Ventura, 0121 371 8145, Maximina.Ventura@uhb.nhs.uk
About this study
Official title: Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation Using Healthcare Data for Pragmatic Research: A Randomised Controlled Trial
The DaRe2 approach (healthcare Data for pragmatic clinical Research in the NHS - primary 2 secondary) is designed to operationalise efficient, nationwide, primary care approaches for randomised trials embedded within the UK National Health Service (NHS), providing automated screening, targeted patient enrolment and 'no-visit' follow-up through innovations in big data and technology solutions.
DaRe2THINK will be the first exemplar of this system, and is appropriately focused on the intersection of key national priorities for healthcare; atrial fibrillation (a heart rhythm condition that will double in prevalence in the next few decades) and the impact this condition has on stroke, thromboembolic events, cognitive impairment and vascular dementia. The trial will test the hypothesis that direct oral anticoagulants (DOACs), now commonly used in older patients with atrial fibrillation (AF), are effective and cost-effective at reducing major adverse clinical events in younger patients at low or intermediate risk of stroke, and can reduce the high rate of cognitive decline. The health technology innovations noted above will allow the investigators to answer this important clinical question, as well as demonstrate the capacity and potential of this system for future, large-scale healthcare-embedded clinical trials for patient benefit.
Read the detailed description
Designed with a Patient and Public Involvement Team, DaRe2THINK is an individual-patient, open-label, event-driven randomised trial with 1:1 allocation to DOAC or no additional therapy (usual care). Automated screening will occur of over 12 million patients in England, with targeted recruitment to practices with eligible patients, regular updates to General Practitioners, simple processes for centre inclusion and patient randomisation, remote e-consent and no additional visits for any patient. The primary outcome is a comprehensive composite of any thromboembolic event, ascertained entirely using electronic healthcare records within both primary and secondary NHS care across the nation. All endpoint data will follow a pre-published coding manual for extracted electronic healthcare data. The key secondary outcome is the change in patient-reported cognitive function, using remote technology solutions to save time for clinical staff and patients. DaRe2THINK will carefully assess and validate safety outcomes relating to major and minor bleeding. A systematic health economic analysis will determine NHS and societal cost-effectiveness of DOAC therapy in this younger population of patients with AF. DaRe2THINK will initially run over a 5-year period (outcomes as listed below), with longer-term outcomes (in particular cardiovascular death, cognitive function and vascular dementia) reassessed at 10 years.
- Conditions
- Atrial Fibrillation
- Being tested
- Direct Oral Anticoagulants
- Keywords
- Atrial fibrillation, anticoagulation, stroke, dementia
- Medical subject headings
- Atrial Fibrillation, Stroke, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Oral AnticoagulantsDrug
Also called apixaban, dabigatran, edoxaban or rivaroxaban
choice of DOAC (apixaban, dabigatran, edoxaban or rivaroxaban) according to local practice
| Study group | Role | What they receive |
|---|---|---|
| Direct Oral anticoagulants (DOAC) | Experimental | Commence DOAC even with low or intermediate risk of stroke or thromboembolism, which could include currently licensed drugs apixaban, dabigatran, edoxaban or rivaroxaban; choice of drug and dose according to local practice guidelines Receives: Drug: Direct Oral Anticoagulants |
| No anticoagulant therapy (usual care) | No intervention | Continuation of usual anticoagulant prescribing practice in patients with AF; e.g. according to National Institute for Health and Care Excellence (NICE), patients with AF should commence oral anticoagulation with a CHA2DS2-VASc score of 2 or above. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite primary endpoint - Time to first event
Composite primary endpoint - Time to first event of cardiovascular mortality, ischaemic cerebrovascular events (stroke and transient ischaemic attacks), all thromboembolic events (including venous and arterial thromboembolism), myocardial infarction and vascular dementia
Measured: 5 years
Secondary outcomes (28)
Change in cognitive function using the UK Biobank fluid intelligence/reasoning test (mixed-effects repeated measures analysis)
Change in cognitive function using the UK Biobank fluid intelligence/reasoning test (mixed-effects repeated measures analysis)
Measured: 5 years
Change in cognitive function using the UK Biobank trail making test (mixed-effects repeated measures analysis)
Change in cognitive function using the UK Biobank trail making test (mixed-effects repeated measures analysis)
Measured: 5 years
Change in cognitive function using the UK Biobank symbol digit substitution test (mixed-effects repeated measures analysis)
Change in cognitive function using the UK Biobank symbol digit substitution test (mixed-effects repeated measures analysis)
Measured: 5 years
. Change in cognitive function using the UK Biobank non-verbal fluid reasoning matrices test (mixed-effects repeated measures analysis)
. Change in cognitive function using the UK Biobank non-verbal fluid reasoning matrices test (mixed-effects repeated measures analysis)
Measured: 5 years
Incremental cost per quality-adjusted life-years gained from the healthcare perspective.
Incremental cost per quality-adjusted life-years gained from the healthcare perspective.
Measured: 5 years
Incremental cost per quality-adjusted life-years gained from the societal perspective.
Incremental cost per quality-adjusted life-years gained from the societal perspective.
Measured: 5 years
Time to composite of major adverse cardiovascular events (non-fatal stroke, non-fatal myocardial infarction and cardiovascular death).
Time to composite of major adverse cardiovascular events (non-fatal stroke, non-fatal myocardial infarction and cardiovascular death).
Measured: 5 years
Time to any major bleeding or clinically-relevant non-major bleeding that requires hospitalisation.
Time to any major bleeding or clinically-relevant non-major bleeding that requires hospitalisation.
Measured: 5 years
Time to minor bleeding that requires attention from primary care (any bleeding that leads to a primary care consultation).
Time to minor bleeding that requires attention from primary care (any bleeding that leads to a primary care consultation).
Measured: 5 years
Time to haemorrhagic stroke and other types of intracranial bleeding.
Time to haemorrhagic stroke and other types of intracranial bleeding.
Measured: 5 years
Number of all-cause general practice visits.
Number of all-cause general practice visits.
Measured: 5 years
Number of all-cause hospital admissions.
Number of all-cause hospital admissions.
Measured: 5 years
Duration of all-cause hospital admissions.
Duration of all-cause hospital admissions.
Measured: 5 years
Number of heart failure hospitalisations.
Number of heart failure hospitalisations.
Measured: 5 years
Duration of heart failure hospitalisations.
Duration of heart failure hospitalisations.
Measured: 5 years
Time to all-cause mortality.
Time to all-cause mortality.
Measured: 5 years
Time to cardiovascular death
Time to cardiovascular death
Measured: 5 years
Patient-reported quality of life using the Euroqol five-dimensions five-level (EQ-5D-5L) summary index score (mixed-effects repeated measures analysis)
Patient-reported quality of life using the Euroqol five-dimensions five-level (EQ-5D-5L) summary index score (mixed-effects repeated measures analysis) Range 0 = death to 1 = complete health
Measured: 5 years
Patient-reported quality of life using the EQ-5D-5L visual analogue score (mixed-effects repeated measures analysis)
Patient-reported quality of life using the EQ-5D-5L visual analogue score (mixed-effects repeated measures analysis) Range 0-100, with a higer score indicating better quality of life.
Measured: 5 years
Time to ischaemic cerebrovascular event (stroke and transient ischaemic attacks)
Time to ischaemic cerebrovascular event (stroke and transient ischaemic attacks)
Measured: 5 years
Cumulative number of ischaemic cerebrovascular events (stroke and transient ischaemic attacks)
Cumulative number of ischaemic cerebrovascular events (stroke and transient ischaemic attacks)
Measured: 5 years
Time to any thromboembolic event (including venous and arterial thromboembolism)
Time to any thromboembolic event (including venous and arterial thromboembolism)
Measured: 5 years
Time to arterial thromboembolic event
Time to arterial thromboembolic event
Measured: 5 years
Time to venous thromboembolic event
Time to venous thromboembolic event
Measured: 5 years
Cumulative number of thromboembolic events (including venous and arterial thromboembolism)
Cumulative number of thromboembolic events (including venous and arterial thromboembolism)
Measured: 5 years
Time to myocardial infarction
Time to myocardial infarction
Measured: 5 years
Cumulative number of myocardial infarctions
Cumulative number of myocardial infarctions
Measured: 5 years
Time to vascular dementia
Time to vascular dementia
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Jun 2021
- Primary completionDec 2027 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individual patient, open-label, event driven RCT with 1:1 allocation to DOAC or no additional therapy (usual care). Choice of DOAC (apixaban, dabigatran, edoxaban or rivaroxaban) according to local practice
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Practice Research Datalink, University Hospital Birmingham NHS Foundation Trust, University of Oxford, London School of Economics and Political Science, Aston University
- Responsible party
- Sponsor
- Investigators
- Dipak Kotecha, Principal investigator, University of Birmingham and University Hospitals Birmingham NHS Foundation TrustJohn Camm, Study chair, St George's University of London; Chair of DaRe2THINK Independent TSCMarcus Flather, Study chair, Norwich Medical School; Chaire of DaRe2THINK Independent DMCDavid Shukla, Principal investigator, Deputy CI; Lead for NIHR West Midlands Primary Care CRN Team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700826
- Sponsor's protocol ID
- ERN_20-1747
- Other IDs
- 290420
- Acronym
- DaRe2THINK
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2020
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Mobley AR, Tica O, Okoth K, Ghosh RE, Myles P, Williams T, Haynes S, Nirantharakumar K, Shukla D, Kotecha D; DaRe2THINK Trial Committees. Systematic approach to outcome assessment from coded electronic healthcare records in the DaRe2THINK NHS-embedded randomized trial. Eur Heart J Digit Health. 2022 Sep 16;3(3):426-436. doi: 10.1093/ehjdh/ztac046. eCollection 2022 Sep.
PubMed 36712153Mobley AR, Subramanian A, Champsi A, Wang X, Myles P, McGreavy P, Bunting KV, Shukla D, Nirantharakumar K, Kotecha D. Thromboembolic events and vascular dementia in patients with atrial fibrillation and low apparent stroke risk. Nat Med. 2024 Aug;30(8):2288-2294. doi: 10.1038/s41591-024-03049-9. Epub 2024 Jun 5.
PubMed 38839900Champsi A, Mobley AR, Subramanian A, Nirantharakumar K, Wang X, Shukla D, Bunting KV, Molgaard I, Dwight J, Arroyo RC, Crijns HJGM, Guasti L, Lettino M, Lumbers RT, Maesen B, Rienstra M, Svennberg E, Tica O, Traykov V, Tzeis S, van Gelder I, Kotecha D. Gender and contemporary risk of adverse events in atrial fibrillation. Eur Heart J. 2024 Sep 29;45(36):3707-3717. doi: 10.1093/eurheartj/ehae539.
PubMed 39217497
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation Using Healthcare Data for Pragmatic Research: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04700826
- Acronym / sponsor ID
- DaRe2THINK / ERN_20-1747
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, anticoagulation, stroke, dementia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Clinical Practice Research Datalink, University Hospital Birmingham NHS Foundation Trust, University of Oxford, London School of Economics and Political Science, Aston University
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 8 Jan 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 DaRe2 approach (healthcare Data for pragmatic clinical Research in the NHS - primary 2 secondary) is designed to operationalise efficient, nationwide, primary care approaches for randomised trials embedded within the UK National Health Service (NHS), providing automated screening, targeted patient enrolment and 'no-visit' follow-up through innovations in big data and technology solutions.
DaRe2THINK will be the first exemplar of this system, and is appropriately focused on the intersection of key national priorities for healthcare; atrial fibrillation (a heart rhythm condition that will double in prevalence in the next few decades) and the impact this condition has on stroke, thromboembolic events, cognitive impairment and vascular dementia. The trial will test the hypothesis that direct oral anticoagulants (DOACs), now commonly used in older patients with atrial fibrillation (AF), are effective and cost-effective at reducing major adverse clinical events in younger patients at low or intermediate risk of stroke, and can reduce the high rate of cognitive decline. The health technology innovations noted above will allow the investigators to answer this important clinical question, as well as demonstrate the capacity and potential of this system for future, large-scale healthcare-embedded clinical trials for patient benefit.
Detailed description
Designed with a Patient and Public Involvement Team, DaRe2THINK is an individual-patient, open-label, event-driven randomised trial with 1:1 allocation to DOAC or no additional therapy (usual care). Automated screening will occur of over 12 million patients in England, with targeted recruitment to practices with eligible patients, regular updates to General Practitioners, simple processes for centre inclusion and patient randomisation, remote e-consent and no additional visits for any patient. The primary outcome is a comprehensive composite of any thromboembolic event, ascertained entirely using electronic healthcare records within both primary and secondary NHS care across the nation. All endpoint data will follow a pre-published coding manual for extracted electronic healthcare data. The key secondary outcome is the change in patient-reported cognitive function, using remote technology solutions to save time for clinical staff and patients. DaRe2THINK will carefully assess and validate safety outcomes relating to major and minor bleeding. A systematic health economic analysis will determine NHS and societal cost-effectiveness of DOAC therapy in this younger population of patients with AF. DaRe2THINK will initially run over a 5-year period (outcomes as listed below), with longer-term outcomes (in particular cardiovascular death, cognitive function and vascular dementia) reassessed at 10 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individual patient, open-label, event driven RCT with 1:1 allocation to DOAC or no additional therapy (usual care). Choice of DOAC (apixaban, dabigatran, edoxaban or rivaroxaban) according to local practice
| Arm | Type | Receives |
|---|---|---|
| Direct Oral anticoagulants (DOAC) | Experimental | Drug: Direct Oral AnticoagulantsCommence DOAC even with low or intermediate risk of stroke or thromboembolism, which could include currently licensed drugs apixaban, dabigatran, edoxaban or rivaroxaban; choice of drug and dose according to local practice guidelines |
| No anticoagulant therapy (usual care) | No intervention | –Continuation of usual anticoagulant prescribing practice in patients with AF; e.g. according to National Institute for Health and Care Excellence (NICE), patients with AF should commence oral anticoagulation with a CHA2DS2-VASc score of 2 or above. |
Who may qualify
- Ages
- 55 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of AF (previous, current or chronic)
- Age at enrolment ≥55 years to ≤73 years
Key exclusion criteria (16 listed)
- Prior documented stroke, transient ischaemic attack or systemic thromboembolism.
- Combination of multiple known risk factors for stroke where oral anticoagulation would ordinarily be started, including: Heart failure; Hypertension; Age 65 years or older; Diabetes mellitus; Previous myocardial infarction, peripheral artery disease or aortic plaque; and/or Female gender.
- Any prior history of intracranial bleeding.
- Prior major bleeding requiring hospitalisation in the last 3 years.
- Condition that poses a significant risk for bleeding (within 12 months) including gastrointestinal ulceration, brain/spinal/ophthalmic injury or surgery, arteriovenous malformations or vascular aneurysms, major intraspinal or intracerebral vascular abnormalities, hepatic disease associated with coagulopathy, known or suspected oesophageal varices, and cancers with high bleeding risk.
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 |
|---|---|---|
| Direct Oral AnticoagulantsAlso: apixaban, dabigatran, edoxaban or rivaroxabanchoice of DOAC (apixaban, dabigatran, edoxaban or rivaroxaban) according to local practice | Drug | Direct Oral anticoagulants (DOAC) |
Primary outcome
Composite primary endpoint - Time to first event
Time frame: 5 years
Composite primary endpoint - Time to first event of cardiovascular mortality, ischaemic cerebrovascular events (stroke and transient ischaemic attacks), all thromboembolic events (including venous and arterial thromboembolism), myocardial infarction and vascular dementia
28 secondary outcomes
Change in cognitive function using the UK Biobank fluid intelligence/reasoning test (mixed-effects repeated measures analysis)
Time frame: 5 years
Change in cognitive function using the UK Biobank trail making test (mixed-effects repeated measures analysis)
Time frame: 5 years
Change in cognitive function using the UK Biobank symbol digit substitution test (mixed-effects repeated measures analysis)
Time frame: 5 years
. Change in cognitive function using the UK Biobank non-verbal fluid reasoning matrices test (mixed-effects repeated measures analysis)
Time frame: 5 years
Incremental cost per quality-adjusted life-years gained from the healthcare perspective.
Time frame: 5 years
Incremental cost per quality-adjusted life-years gained from the societal perspective.
Time frame: 5 years
Time to composite of major adverse cardiovascular events (non-fatal stroke, non-fatal myocardial infarction and cardiovascular death).
Time frame: 5 years
Time to any major bleeding or clinically-relevant non-major bleeding that requires hospitalisation.
Time frame: 5 years
Time to minor bleeding that requires attention from primary care (any bleeding that leads to a primary care consultation).
Time frame: 5 years
Time to haemorrhagic stroke and other types of intracranial bleeding.
Time frame: 5 years
Number of all-cause general practice visits.
Time frame: 5 years
Number of all-cause hospital admissions.
Time frame: 5 years
Duration of all-cause hospital admissions.
Time frame: 5 years
Number of heart failure hospitalisations.
Time frame: 5 years
Duration of heart failure hospitalisations.
Time frame: 5 years
Time to all-cause mortality.
Time frame: 5 years
Time to cardiovascular death
Time frame: 5 years
Patient-reported quality of life using the Euroqol five-dimensions five-level (EQ-5D-5L) summary index score (mixed-effects repeated measures analysis)
Time frame: 5 years
Patient-reported quality of life using the EQ-5D-5L visual analogue score (mixed-effects repeated measures analysis)
Time frame: 5 years
Time to ischaemic cerebrovascular event (stroke and transient ischaemic attacks)
Time frame: 5 years
Cumulative number of ischaemic cerebrovascular events (stroke and transient ischaemic attacks)
Time frame: 5 years
Time to any thromboembolic event (including venous and arterial thromboembolism)
Time frame: 5 years
Time to arterial thromboembolic event
Time frame: 5 years
Time to venous thromboembolic event
Time frame: 5 years
Cumulative number of thromboembolic events (including venous and arterial thromboembolism)
Time frame: 5 years
Time to myocardial infarction
Time frame: 5 years
Cumulative number of myocardial infarctions
Time frame: 5 years
Time to vascular dementia
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 36712153Wang X, Mobley AR, Tica O, Okoth K, Ghosh RE, Myles P, Williams T, Haynes S, Nirantharakumar K, Shukla D, Kotecha D; DaRe2THINK Trial Committees. Systematic approach to outcome assessment from coded electronic healthcare records in the DaRe2THINK NHS-embedded randomized trial. Eur Heart J Digit Health. 2022 Sep 16;3(3):426-436. doi: 10.1093/ehjdh/ztac046. eCollection 2022 Sep.
- Background: PubMed 38839900Mobley AR, Subramanian A, Champsi A, Wang X, Myles P, McGreavy P, Bunting KV, Shukla D, Nirantharakumar K, Kotecha D. Thromboembolic events and vascular dementia in patients with atrial fibrillation and low apparent stroke risk. Nat Med. 2024 Aug;30(8):2288-2294. doi: 10.1038/s41591-024-03049-9. Epub 2024 Jun 5.
- Background: PubMed 39217497Champsi A, Mobley AR, Subramanian A, Nirantharakumar K, Wang X, Shukla D, Bunting KV, Molgaard I, Dwight J, Arroyo RC, Crijns HJGM, Guasti L, Lettino M, Lumbers RT, Maesen B, Rienstra M, Svennberg E, Tica O, Traykov V, Tzeis S, van Gelder I, Kotecha D. Gender and contemporary risk of adverse events in atrial fibrillation. Eur Heart J. 2024 Sep 29;45(36):3707-3717. doi: 10.1093/eurheartj/ehae539.
- Individual participant dataSharing planned: No
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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.
Dipak Kotecha principal investigator
University of Birmingham and University Hospitals Birmingham NHS Foundation Trust
John Camm study chair
St George's University of London; Chair of DaRe2THINK Independent TSC
Marcus Flather study chair
Norwich Medical School; Chaire of DaRe2THINK Independent DMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Direct Oral Anticoagulants in people with Atrial Fibrillation, run by University of Birmingham 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 2 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 16 May 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alastair Mobley, BSc (+44 121 371 4225, a.mobley@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite primary endpoint - Time to first event (time frame: 5 years). 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 NCT04700826, which also lists 3 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 16 May 2025.