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

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.

Conditions

• Atrial Fibrillation

Interventions

DRUG

Direct Oral Anticoagulants

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

Sponsors & Collaborators

• Clinical Practice Research Datalink

  collaborator OTHER_GOV

• University Hospital Birmingham NHS Foundation Trust

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• London School of Economics and Political Science

  collaborator OTHER

• Aston University

  collaborator OTHER

• University of Birmingham

  lead OTHER

Principal Investigators

• Dipak Kotecha · University of Birmingham and University Hospitals Birmingham NHS Foundation Trust

• John Camm · St George's University of London; Chair of DaRe2THINK Independent TSC

• Marcus Flather · Norwich Medical School; Chaire of DaRe2THINK Independent DMC

• David Shukla · Deputy CI; Lead for NIHR West Midlands Primary Care CRN Team

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

73 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-01

Primary Completion

2027-12-31

Completion

2031-01-31

Countries

• United Kingdom

Study Locations