RecruitingPhase 4NCT04700826

Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation

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


Sponsor

University of Birmingham

Enrollment

3,000 participants

Start Date

Jun 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 55 YearsMax Age: 73 Years

Plain Language Summary

Simplified for easier understanding

This trial studies whether blood-thinning medication can prevent stroke, premature death, and cognitive decline in people with atrial fibrillation (irregular heart rhythm) who are at relatively low stroke risk. **You may be eligible if...** - You have been diagnosed with atrial fibrillation - You are between 55 and 73 years old **You may NOT be eligible if...** - You have had a prior stroke, mini-stroke (TIA), or blood clot that traveled to another part of your body - You have multiple combined stroke risk factors - You have had bleeding inside the brain - You were hospitalized for major bleeding in the last 3 years - You have a condition that puts you at significant risk of bleeding - Your kidney function is very low (eGFR below 30) - You recently used certain antifungal medications - You have been diagnosed with dementia - You cannot tolerate blood-thinning medications (DOACs) - You are already taking blood thinners Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDirect Oral Anticoagulants

choice of DOAC (apixaban, dabigatran, edoxaban or rivaroxaban) according to local practice


Locations(1)

University Hospitals Birmingham

Birmingham, West Midlands, United Kingdom

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NCT04700826


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