NCT04700826 · Phase 4 · RECRUITING
Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation
This trial tests whether blood-thinning pills called direct oral anticoagulants can lower the rate of stroke and other serious events, and slow cognitive decline, in people with atrial fibrillation (an irregular heartbeat) who are at lower stroke risk. It is a Phase 4 trial, meaning the drugs are already approved and this studies broader use.
Eligibility criteria
Inclusion Criteria: 1. Diagnosis of AF (previous, current or chronic) 2. Age at enrolment ≥55 years to ≤73 years Exclusion Criteria based on coding in Primary Care: 1. Prior documented stroke, transient ischaemic attack or systemic thromboembolism. 2. 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. 3. Any prior history of intracranial bleeding. 4. Prior major bleeding requiring hospitalisation in the last 3 years. 5. 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. 6. Estimated glomerular filtration rate \<30 mL/min/1.73m2 measured within the last 12 months. 7. Patients receiving systemic treatment with azole-antimycotics within the last 3 months (ketoconazole, itraconazole, voriconazole and posaconazole). 8. Documented diagnosis of dementia. 9. Hypersensitivity or known intolerance to direct oral anticoagulants. Exclusion criteria based on review by Primary Care staff: 1. Currently receiving an anticoagulant. 2. Any clinical indication for anticoagulation. 3. Active clinically-significant bleeding. 4. Life expectancy estimated \<2 years. 5. Participant unable or unwilling to provide informed consent for access and linkage of past and future electronic healthcare records. 6. Currently participating in another clinical trial. 7. Women of childbearing potential.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-05-16