ISRCTN21157803
Active, not recruiting
Phase 4
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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Atrial fibrillation
- Sponsor
- niversity of Birmingham
- Enrollment
- 3000
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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