NCT04700826 Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation
| NCT ID | NCT04700826 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Birmingham |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 3,000 participants in total. It began in 2021-06-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 '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.
Eligibility Criteria
Inclusion Criteria: 1. Diagnosis of AF (previous, current or chronic) 2. Age at enrolment ≥55 years to ≤73 years Exclusion Criteria based on coding in Primary Care: 1. Prior documented stroke, transient ischaemic attack or systemic thromboembolism. 2. 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. 3. Any prior history of intracranial bleeding. 4. Prior major bleeding requiring hospitalisation in the last 3 years. 5. 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. 6. Estimated glomerular filtration rate \<30 mL/min/1.73m2 measured within the last 12 months. 7. Patients receiving systemic treatment with azole-antimycotics within the last 3 months (ketoconazole, itraconazole, voriconazole and posaconazole). 8. Documented diagnosis of dementia. 9. Hypersensitivity or known intolerance to direct oral anticoagulants. Exclusion criteria based on review by Primary Care staff: 1. Currently receiving an anticoagulant. 2. Any clinical indication for anticoagulation. 3. Active clinically-significant bleeding. 4. Life expectancy estimated \<2 years. 5. Participant unable or unwilling to provide informed consent for access and linkage of past and future electronic healthcare records. 6. Currently participating in another clinical trial. 7. Women of childbearing potential.
Contact & Investigator
Dipak Kotecha
PRINCIPAL INVESTIGATOR
University of Birmingham and University Hospitals Birmingham NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT04700826 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 73 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04700826 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04700826 currently recruiting?
Yes, NCT04700826 is actively recruiting participants. Contact the research team at a.mobley@bham.ac.uk for enrollment information.
Where is the NCT04700826 trial being conducted?
This trial is being conducted at Birmingham, United Kingdom.
Who is sponsoring the NCT04700826 clinical trial?
NCT04700826 is sponsored by University of Birmingham. The principal investigator is Dipak Kotecha at University of Birmingham and University Hospitals Birmingham NHS Foundation Trust. The trial plans to enroll 3,000 participants.
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