[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416297":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":42,"locations":50,"responsibleParty":70,"collaborators":72,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":18,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":53,"whyStopped":18,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University of Birmingham","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Direct Oral anticoagulants (DOAC)","EXPERIMENTAL","Commence DOAC even with low or intermediate risk of stroke or thromboembolism, which could include currently licensed drugs apixaban, dabigatran, edoxaban or rivaroxaban; choice of drug and dose according to local practice guidelines",[13],"Drug: Direct Oral Anticoagulants",{"label":15,"type":16,"description":17,"interventionNames":18},"No anticoagulant therapy (usual care)","NO_INTERVENTION","Continuation of usual anticoagulant prescribing practice in patients with AF; e.g. according to National Institute for Health and Care Excellence (NICE), patients with AF should commence oral anticoagulation with a CHA2DS2-VASc score of 2 or above.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Direct Oral Anticoagulants","choice of DOAC (apixaban, dabigatran, edoxaban or rivaroxaban) according to local practice",[9],[26],"apixaban, dabigatran, edoxaban or rivaroxaban",[28,32,36,39],{"name":29,"affiliation":30,"role":31},"Dipak Kotecha","University of Birmingham and University Hospitals Birmingham NHS Foundation Trust","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":34,"role":35},"John Camm","St George's University of London; Chair of DaRe2THINK Independent TSC","STUDY_CHAIR",{"name":37,"affiliation":38,"role":35},"Marcus Flather","Norwich Medical School; Chaire of DaRe2THINK Independent DMC",{"name":40,"affiliation":41,"role":31},"David Shukla","Deputy CI; Lead for NIHR West Midlands Primary Care CRN Team",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":18,"email":47},"Alastair Mobley, BSc","CONTACT","+44 121 371 4225","a.mobley@bham.ac.uk",{"name":29,"role":45,"phone":46,"phoneExt":18,"email":49},"d.kotecha@bham.ac.uk",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"University Hospitals Birmingham","RECRUITING","Birmingham","West Midlands","B15 2TH","United Kingdom","UK",{"type":60,"coordinates":61},"Point",[62,63],-1.89983,52.48142,{"lat":63,"lon":62},[66],{"name":67,"role":45,"phone":68,"phoneExt":18,"email":69},"Minnie Ventura","0121 371 8145","Maximina.Ventura@uhb.nhs.uk",{"type":71,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[73,76,78,80,82],{"name":74,"class":75},"Clinical Practice Research Datalink","OTHER_GOV",{"name":77,"class":6},"University Hospital Birmingham NHS Foundation Trust",{"name":79,"class":6},"University of Oxford",{"name":81,"class":6},"London School of Economics and Political Science",{"name":83,"class":6},"Aston University","100416297","phase-4-preventing-stroke-premature-death-and-cognitive-decline-in-a-broader-community-of-patients-with-atrial-fibrillation-100416297",false,"NCT04700826","Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of 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","DaRe2THINK","Inclusion Criteria:\n\n1. Diagnosis of AF (previous, current or chronic)\n2. Age at enrolment ≥55 years to ≤73 years\n\nExclusion Criteria based on coding in Primary Care:\n\n1. Prior documented stroke, transient ischaemic attack or systemic thromboembolism.\n2. 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\u002For Female gender.\n3. Any prior history of intracranial bleeding.\n4. Prior major bleeding requiring hospitalisation in the last 3 years.\n5. Condition that poses a significant risk for bleeding (within 12 months) including gastrointestinal ulceration, brain\u002Fspinal\u002Fophthalmic 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.\n6. Estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m2 measured within the last 12 months.\n7. Patients receiving systemic treatment with azole-antimycotics within the last 3 months (ketoconazole, itraconazole, voriconazole and posaconazole).\n8. Documented diagnosis of dementia.\n9. Hypersensitivity or known intolerance to direct oral anticoagulants.\n\nExclusion criteria based on review by Primary Care staff:\n\n1. Currently receiving an anticoagulant.\n2. Any clinical indication for anticoagulation.\n3. Active clinically-significant bleeding.\n4. Life expectancy estimated \\\u003C2 years.\n5. Participant unable or unwilling to provide informed consent for access and linkage of past and future electronic healthcare records.\n6. Currently participating in another clinical trial.\n7. Women of childbearing potential.","ALL","55 Years","73 Years",{"count":96,"type":97},3000,"ESTIMATED","INTERVENTIONAL",[100],"PHASE4","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.\n\nDaRe2THINK 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.",[103],"Atrial Fibrillation",[105,106,107,108],"Atrial fibrillation","anticoagulation","stroke","dementia","2025-05-13",{"date":111,"type":112},"2025-05-16","ACTUAL",{"date":114,"type":112},"2021-06-01",{"date":116,"type":97},"2031-01",{"name":5,"class":6},1]