Preventing stroke and cognitive decline in patients with atrial fibrillation

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

This study is testing if a new blood thinner can help younger people with atrial fibrillation avoid strokes and keep their thinking sharp over time.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3000 (estimated)
• Ages: 55 Years to 73 Years
• Sex: All
• Sponsor: University of Birmingham (Academic / other)
• Locations: 1 site (Birmingham, West Midlands)
• Trial ID: NCT04700826 on ClinicalTrials.gov

What this trial studies

This trial, known as DaRe2THINK, aims to evaluate the effectiveness and cost-effectiveness of direct oral anticoagulants (DOACs) in reducing major adverse clinical events in younger patients with atrial fibrillation (AF). It utilizes a nationwide approach within the UK National Health Service (NHS) to automate patient screening and recruitment, allowing for remote consent and follow-up. The study will assess outcomes related to thromboembolic events and cognitive function using electronic healthcare records and patient-reported measures. The trial is designed to run for five years, with longer-term outcomes evaluated over a decade.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 55 to 73 years diagnosed with atrial fibrillation.

Not a fit: Patients with a history of stroke, significant bleeding risks, or other serious comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could significantly reduce the incidence of stroke and cognitive decline in patients with atrial fibrillation.

How similar studies have performed: Other studies have shown promise in using direct oral anticoagulants for atrial fibrillation, but this specific approach is innovative and aims to operationalize a nationwide screening and recruitment strategy.

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.

Where this trial is running

Birmingham, West Midlands

• University Hospitals Birmingham — Birmingham, West Midlands, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Dipak Kotecha — University of Birmingham and University Hospitals Birmingham NHS Foundation Trust
• Study coordinator: Alastair Mobley, BSc

Conditions Atrial Fibrillation; Atrial fibrillation; anticoagulation; stroke; dementia