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

Study acronym: DaRe2THINK
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Notable Primary completion date: Jan 2026 to Dec 2027v4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 30, 2021 to Jun 1, 2021
    • Eligibility criteria shortened, about 5 words
    v3
  3. Notable Start date: Jan 2021 to Apr 30, 2021
    • Primary endpoint revised
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints revised (28)
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
8,786 trials monitored
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and 1 more disease
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.
Trial Details
NCT Number NCT04700826
Lead Sponsor University of Birmingham
Collaborators: Clinical Practice Research Datalink, University Hospital Birmingham NHS Foundation Trust, University of Oxford, London School of Economics and Political Science, Aston University
Conditions
(from sponsor)
Atrial Fibrillation
Related terms Atrial Fibrillation, Dementia, Stroke
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov