Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation

• Status: Not yet recruiting
• Trial end date: 2031-01-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Birmingham
• Collaborators: Aston University; Clinical Practice Research Datalink; London School of Economics and Political Science; University Hospital Birmingham NHS Foundation Trust; University of Oxford
• Treatments: Anticoagulants; Apixaban; Dabigatran; Edoxaban; Rivaroxaban

Criteria

Inclusion Criteria:

1. Diagnosis of AF (previous, current or chronic)

2. Age >=60 years to <=73 years

Exclusion Criteria:

1. Existing use of an anticoagulant.

2. Another clinical indication for anticoagulation.

3. Hypersensitivity or known intolerance to direct oral anticoagulants.

4. Prior documented stroke, transient ischaemic attack or thromboembolism.

5. Two or more CHA2DS2-VASc one-point risk factors: Heart failure (confirmed by use of loop diuretic therapy within the last 3 months); Hypertension (confirmed by use of anti-hypertensive therapy within the last 3 months); Age 65 years or older; Diabetes mellitus (confirmed by use of oral antidiabetic therapy or insulin within the last 3 months); Previous myocardial infarction, peripheral artery disease or aortic plaque; and/or Female gender.

6. Active clinically-significant bleeding

7. Prior major bleeding, defined as any intracranial bleed, or bleeding that resulted in a drop in haemoglobin ≥2g/dL, required hospitalisation or transfusion.

8. 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.

9. Estimated glomerular filtration rate <30 mL/min/1.73m2 measured within the last 6 months.

10. Patients receiving systemic treatment with azole-antimycotics within the last 3 months (ketoconazole, itraconazole, voriconazole and posaconazole).

11. Current diagnosis of dementia.

12. Life expectancy <2 years.

13. Unable or unwilling to provide informed consent for access and linkage of past and future electronic healthcare records.