[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525659":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":73,"collaborators":77,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":10,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":10,"enrollmentInfo":90,"targetDuration":10,"studyType":93,"phases":10,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":57,"whyStopped":10,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"East and North Hertfordshire NHS Trust","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Atrial fibrillation",null,"Patients already enrolled in main OCEANIC-AF study.",[13],"Diagnostic Test: Thrombotic assessment",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","Thrombotic assessment","GTT\n\nThe Global Thrombosis Test (GTT) (Thromboquest Limited, UK) is an in vitro method imitating high shear stress conditions akin to that which exist in a severely stenosed artery. The test measures platelet reactivity (occlusion time) and endogenous fibrinolysis time (lysis time).\n\nTEG Thromboelastography (TEG, Haemonetics Corporation, USA) is a technique that assesses the whole process of clotting and its viscoelastic properties, from the initial activation and aggregation of platelets, to the role of thrombin and finally the stability of the formed clot, as a measure of fibrinolytic resistance.\n\nCitrated plasma will be stored for subsequent evaluation of thrombosis and fibrinolysis markers (including but not restricted to D-dimer, PAI-1, hs-CRP, NETs)",[9],[21],{"name":22,"affiliation":5,"role":23},"Diana A Gorog, MD, PhD","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Joshua H Leader, MBCHB, BSc","CONTACT","07376188768","joshua.leader@nhs.net",{"name":22,"role":27,"phone":31,"phoneExt":10,"email":32},"01707247512","d.gorog@imperial.ac.uk",[34,55],{"facility":35,"status":36,"city":37,"state":10,"zip":10,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Liverpool Heart and Chest Hospital","NOT_YET_RECRUITING","Liverpool","United Kingdom","UK",{"type":41,"coordinates":42},"Point",[43,44],-2.97794,53.41058,{"lat":44,"lon":43},[47,51,53],{"name":48,"role":27,"phone":49,"phoneExt":10,"email":50},"Ying Gue","+44(0)151 794 9020","y.gue@nhs.net",{"name":52,"role":23,"phone":10,"phoneExt":10,"email":10},"Gregory Lip",{"name":48,"role":54,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"facility":56,"status":57,"city":58,"state":10,"zip":10,"country":38,"countryCode":39,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"East and North Herts NHS Trust","RECRUITING","Stevenage",{"type":41,"coordinates":60},[61,62],-0.20256,51.90224,{"lat":62,"lon":61},[65,69,71],{"name":66,"role":27,"phone":67,"phoneExt":10,"email":68},"Toral Odedra","07918 360 060","grantapplications.enh-tr@nhs.net",{"name":70,"role":23,"phone":10,"phoneExt":10,"email":10},"Diana A Gorog",{"name":72,"role":54,"phone":10,"phoneExt":10,"email":10},"Joshua H Leader",{"type":23,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":76,"oldNameTitle":10,"oldOrganization":10},"Prof Diana Gorog","Professor","University of Hertfordshire",[78],{"name":79,"class":80},"Liverpool Heart and Chest Hospital NHS Foundation Trust","OTHER","100525659","an-investigator-initiated-linked-study-to-oceanic-af-100525659",false,"NCT06124612","An Investigator-initiated Linked Study to OCEANIC-AF","Assessing the Effect of Asundexian on Thrombotic Status, in Particular Endogenous Fibrinolysis, in Patients With Atrial Fibrillation","Inclusion Criteria:\n\n1. Patients aged 18 years or over\n2. Patients enrolled in OCEANIC-AF study\n3. Free from the exclusion criteria below\n4. The patient is willing and able to understand the Patient Information Sheet and provide written informed consent\n5. The patient agrees to comply with the drawing of blood samples for the assessments.\n\nExclusion Criteria:\n\n1. Inability to provide valid informed consent\n2. Patients aged \\\u003C 18 years of age\n3. Patients with significant neurological, hepatic, renal, endocrine, gastrointestinal, pulmonary, haemorrhagic, metabolic or other disease likely to confound the study requirements or analyses\n4. Patients with a history of substance abuse or signs or clinical features of active substance abuse or psychiatric disease\n5. Alcohol consumption above 21 units per week\n6. Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study\n7. Any major bleeding diathesis or blood dyscrasia (platelets \\\u003C70 x 109\u002Fl, Hb \\\u003C80 g\u002Fdl, INR \\>1.4, APTT \\>x 2 UNL, leucocyte count \\\u003C3.5 x 109\u002Fl, neutrophil count \\\u003C1 x 109\u002Fl)","ALL","18 Years",{"count":91,"type":92},100,"ESTIMATED","OBSERVATIONAL","Impaired endogenous fibrinolysis is a recently recognised risk factor for thrombotic events in patients with cardiovascular disease. Enhancing endogenous fibrinolysis in such individuals represents a way of reducing thrombosis risk. However, the optimal pharmacotherapy to enhance fibrinolysis is unclear.\n\nThe aim of this study is to assess the effect of asundexian on endogenous fibrinolysis and compare this to apixaban. If asundexian can enhance endogenous fibrinolysis, this could be used as targeted treatment for patients who despite optimal antithrombotic therapy, demonstrate impaired endogenous fibrinolysis.",[96],"Atrial Fibrillation",[9,98,99],"Endogenous fibrinolysis","Global thrombosis test","2023-11-05",{"date":102,"type":103},"2023-11-09","ACTUAL",{"date":105,"type":92},"2023-11-03",{"date":107,"type":92},"2026-09-17",{"name":5,"class":6},2]