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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age55-73
SponsorUniversity of Birmingham

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

3,000 Participants
are divided into 2 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