About this 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.
Eligibility criteria
Qualifiers
Diagnosis of AF (previous, current or chronic)
Age at enrolment ≥55 years to ≤73 years
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Direct Oral Anticoagulants
Treatment groups
Sponsors and collaborators
University of Birmingham
Lead sponsor
Clinical Practice Research Datalink
Collaborator
University Hospital Birmingham NHS Foundation Trust
Collaborator
University of Oxford
Collaborator
London School of Economics and Political Science
Collaborator
Aston University
Collaborator