Status:
RECRUITING
Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation
Lead Sponsor:
University of Birmingham
Collaborating Sponsors:
Clinical Practice Research Datalink
University Hospital Birmingham NHS Foundation Trust
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
55-73 years
Phase:
PHASE4
Brief 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...
Detailed Description
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). A...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- 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.
- Condition that poses a significant risk for bleeding (within 12 months) including gastrointestinal ulceration, brain/spinal/ophthalmic injury or surgery, arteriovenous malformations or vascular aneurysms, major intraspinal or intracerebral vascular abnormalities, hepatic disease associated with coagulopathy, known or suspected oesophageal varices, and cancers with high bleeding risk.
- Estimated glomerular filtration rate \<30 mL/min/1.73m2 measured within the last 12 months.
- Patients receiving systemic treatment with azole-antimycotics within the last 3 months (ketoconazole, itraconazole, voriconazole and posaconazole).
- Documented diagnosis of dementia.
- Hypersensitivity or known intolerance to direct oral anticoagulants.
- Exclusion criteria based on review by Primary Care staff:
- Currently receiving an anticoagulant.
- Any clinical indication for anticoagulation.
- Active clinically-significant bleeding.
- Life expectancy estimated \<2 years.
- Participant unable or unwilling to provide informed consent for access and linkage of past and future electronic healthcare records.
- Currently participating in another clinical trial.
- Women of childbearing potential.
Exclusion
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2031
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT04700826
Start Date
June 1 2021
End Date
January 1 2031
Last Update
May 16 2025
Active Locations (1)
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1
University Hospitals Birmingham
Birmingham, West Midlands, United Kingdom, B15 2TH