Preventing stroke, premature death and cognitive decline in a broader community of patients with atrial fibrillation using healthcare data for pragmatic research: A randomised controlled trial
Atrial fibrillation
Participants will be randomised to one of two groups in a 1:1 ratio by a computer generated algorithm: Group 1: Standard of Care Group 2: Direct Oral Anticoagulant (DOACs) Follow-up takes place remotely through the extraction of participants' health records and remote completion of patient reported outcome questionnaires (every 6months) and cognitive function tests (every 12months) using their personal electronic device, up to 5 years. Drugs used and dosage: Apixaban 5mg twice daily, or 2.5mg twice daily if meeting criteria for reduced dose. Dabigatran 150mg twice daily, or 110mg twice daily if meeting criteria for reduced dose. Edoxaban 60mg once daily, or 30mg once daily if meeting criteria for reduced dose. Rivaroxaban 20mg once daily, or 15mg once daily if meeting criteria for reduced dose.
Current inclusion criteria as of 19/06/2023: 1. Diagnosis of AF (previous, current or chronic) 2. Age at enrolment >=55 years to <=73 years _____ Previous inclusion criteria: 1. Diagnosis of AF (previous, current or chronic) 2. Age at enrolment >=60 years to <=73 years
Current exclusion criteria as of 01/11/2022: Participant exclusion criteria based on coding in the Primary Care record: 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. Participant 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. _____ Previous exclusion criteria as of 21/09/2021: 1. Existing use of an anticoagulant. 2. Another clinical indication for anticoagulation. 3. Hypersensitivity or kno