At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- Mix of remote tasks and in-person visits
- Drug or intervention
- Direct Oral Anticoagulants (drug)
- How long the study runs
- Study runs about 115 months (dates as stated)
- About the drug or intervention
- Direct Oral Anticoagulants — drug: choice of DOAC (apixaban, dabigatran, edoxaban or rivaroxaban) according to local practice
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 55 Years to 73 Years
- Who
- All
- Number of participants
- 3,000
- Started
- 2021-06-01
- Last checked
- 2024-12
Plain English Summary
What is this study?
- • Testing a new treatment for atrial fibrillation
- • Phase4 - 3,000 participants
- • 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
Who can take part?
- • Ages 55 Years to 73 Years
- • Diagnosed with atrial fibrillation
Where?
- • Birmingham - University Hospitals Birmingham
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
Designed with a Patient and Public Involvement Team, DaRe2THINK is an individual-patient, open-label, event-driven randomised trial with 1:1 allocation to DOAC or no additional therapy (usual care). Automated screening will occur of over 12 million patients in England, with targeted recruitment to practices with eligible patients, regular updates to General Practitioners, simple processes for centre inclusion and patient randomisation, remote e-consent and no additional visits for any patient. The primary outcome is a comprehensive composite of any thromboembolic event, ascertained entirely using electronic healthcare records within both primary and secondary NHS care across the nation. All endpoint data will follow a pre-published coding manual for extracted electronic healthcare data. The key secondary outcome is the change in patient-reported cognitive function, using remote technology solutions to save time for clinical staff and patients. DaRe2THINK will carefully assess and validate safety outcomes relating to major and minor bleeding. A systematic health economic analysis will determine NHS and societal cost-effectiveness of DOAC therapy in this younger population of patients with AF. DaRe2THINK will initially run over a 5-year period (outcomes as listed below), with longer-term outcomes (in particular cardiovascular death, cognitive function and vascular dementia) reassessed at 10 years.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 55 Years - 73 Years
- Who can join: All genders
What the study is looking for
- ✓Diagnosis of AF (previous, current or chronic)
- ✓Age at enrolment ≥55 years to ≤73 years
- ✓Exclusion Criteria based on coding in Primary Care:
- ✓Prior documented stroke, transient ischaemic attack or systemic thromboembolism.
- ✓Any prior history of intracranial bleeding.
See the full criteria
Where Is This Study? (1 UK site)
University Hospitals Birmingham
Birmingham B15 2TH, United Kingdom
How to Get in Touch
Alastair Mobley, BSc
Sponsor contactCONTACT
Dipak Kotecha
Sponsor contactCONTACT