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New treatment option for Atrial Fibrillation
Official title Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation
ClinicalTrials.gov ID: NCT04700826
What this study is testing
What is Direct Oral Anticoagulants?
Direct Oral Anticoagulants is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for atrial fibrillation.
Also referred to as apixaban, dabigatran, edoxaban or rivaroxaban.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 73
You may be able to join if
- Diagnosis of AF (previous, current or chronic)
- Age at enrolment ≥55 years to ≤73 years
You likely can't join if
- based on coding in Primary Care:
- Prior documented stroke, transient ischaemic attack or systemic thromboembolism.
- Combination of multiple known risk factors for stroke where oral anticoagulation would ordinarily be started, including: Heart failure; Hypertension...
- Any prior history of intracranial bleeding.
- Prior major bleeding requiring hospitalisation in the last 3 years.
- Condition that poses a significant risk for bleeding (within 12 months) including gastrointestinal ulceration, brain/spinal/ophthalmic injury or...
See the full eligibility criteria
- Diagnosis of AF (previous, current or chronic)
- Age at enrolment ≥55 years to ≤73 years
- based on coding in Primary Care:
- Prior documented stroke, transient ischaemic attack or systemic thromboembolism.
- 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...
- Any prior history of intracranial bleeding.
- Prior major bleeding requiring hospitalisation in the last 3 years.
- 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...
- Estimated glomerular filtration rate \<30 mL/min/1.73m2 measured within the last 12 months.
- Patients receiving systemic treatment with azole-antimycotics within the last 3 months (ketoconazole, itraconazole, voriconazole and posaconazole).
- Documented diagnosis of dementia.
- Hypersensitivity or known intolerance to direct oral anticoagulants. Exclusion criteria based on review by Primary Care staff:
- Currently receiving an anticoagulant.
- Any clinical indication for anticoagulation.
- Active clinically-significant bleeding.
- Life expectancy estimated \<2 years.
- Participant unable or unwilling to provide informed consent for access and linkage of past and future electronic healthcare records.
- Currently participating in another clinical trial.
- Women of childbearing potential.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, West Midlands, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 73 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, West Midlands, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.