Actively Recruiting
Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation
Led by University of Birmingham · Updated on 2025-05-16
3000
Participants Needed
1
Research Sites
500 weeks
Total Duration
On this page
Sponsors
U
University of Birmingham
Lead Sponsor
C
Clinical Practice Research Datalink
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of atrial fibrillation (previous, current or chronic)
- Age at enrollment between 55 and 73 years
You will not qualify if you...
- Prior stroke, transient ischemic attack, or systemic thromboembolism
- Multiple stroke risk factors requiring anticoagulation including heart failure, hypertension, age 65 or older, diabetes, prior heart attack or peripheral artery disease, and/or female gender
- History of intracranial bleeding
- Major bleeding requiring hospitalization in the last 3 years
- Conditions posing significant bleeding risk within 12 months such as gastrointestinal ulcers, brain/spinal/eye injury or surgery, vascular malformations or aneurysms, liver disease with clotting problems, esophageal varices, or high-risk cancers
- Severe kidney impairment (eGFR less than 30 mL/min/1.73m2) measured within 12 months
- Systemic treatment with certain antifungal medications (azole-antimycotics) in the last 3 months
- Documented diagnosis of dementia
- Allergy or intolerance to direct oral anticoagulants
- Currently on anticoagulant treatment
- Any clinical reason requiring anticoagulation
- Active significant bleeding
- Life expectancy less than 2 years
- Unable or unwilling to consent for use of electronic healthcare records
- Participation in another clinical trial
- Women who can become pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospitals Birmingham
Birmingham, West Midlands, United Kingdom, B15 2TH
Actively Recruiting
Research Team
A
Alastair Mobley, BSc
CONTACT
D
Dipak Kotecha
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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