[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492077":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":59,"collaborators":40,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":40,"enrollmentInfo":71,"targetDuration":40,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":87,"whyStopped":40,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group","EXPERIMENTAL","Patients treated with apixaban 5 mg twice daily (BID)",[13],"Drug: Apixaban 5 MG Oral Tablet",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Comparator group:","ACTIVE_COMPARATOR","Patients treated with Aspirin 75 to 100mg once a day",[19],"Drug: Aspirin 75 to 100mg once a day",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","Apixaban 5 MG Oral Tablet",[9],[9],{"type":22,"name":27,"description":17,"armGroupLabels":28,"otherNames":29},"Aspirin 75 to 100mg once a day",[15],[30],"Active Comparator",[32],{"name":33,"affiliation":34,"role":35},"Jean-Guillaume DILLINGER, Professor","Assistance Publique Hôpitaux Paris","PRINCIPAL_INVESTIGATOR",[37,42],{"name":33,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","+33 1 49 95 86 74",null,"jean-guillaume.dillinger@aphp.fr",{"name":43,"role":38,"phone":44,"phoneExt":40,"email":45},"Bernard IUNG, Professor","+33 1 40 25 66 01","bernard.iung@aphp.fr",[47],{"facility":48,"status":40,"city":49,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":40},"Service de Cardiologie Hôpital Lariboisière","Paris","75010","France","FR",{"type":54,"coordinates":55},"Point",[56,57],2.3488,48.85341,{"lat":57,"lon":56},{"type":60,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100492077","phase-3-direct-oral-anticoagulation-and-bioprothesis-aortic-valve-100492077",false,"NCT05687448","DIrect Oral Anticoagulation and Bioprothesis Aortic Valve","DIrect Oral Anticoagulant for Antithrombotic Management Of Aortic Bioprothesis Valve implaNted Patients for Valvular Heart Disease Study","DIAMOND","Inclusion Criteria:\n\n1. Male or female ≥18 years of age\n2. Prior implantation of a surgical bioprosthesis in the aortic position at least 7 days and before hospital discharge (excluding TAVI)\n3. Participants currently not requiring chronic anticoagulation for another reason (atrial fibrillation, pulmonary embolism or any other condition)\n4. Patients affiliated to social security\n5. Patient able to give free, informed and written consent\n\nExclusion Criteria:\n\n1. Any cardiac surgery less than 7 days prior to enrollment or more than 1 month\n2. Mechanical valve in any position or combined valve surgery (mitral or tricuspid).\n3. Any major bleeding in the three months (90 days) prior to enrollment.\n4. Active bleeding or high risk of bleeding after cardiac surgery (i.e. hemopericardium) or lesion or condition considered as a significant risk factor for major bleeding according to investigator\n5. Atrial fibrillation requiring chronic anticoagulation\n6. Need to be on dual antiplatelet therapy (aspirin \\>100 mg daily and a P2Y12 inhibitor, i.e. clopidogrel, ticagrelor, prasugrel) or requiring chronic anticoagulation whatever the treatment (oral or injection).\n7. Known hypersensitivity or other contraindications to apixaban (hepatic disease associated with coagulopathy and clinically relevant bleeding risk).\n8. Creatinine clearance \\\u003C40 mL\u002Fmin (Cockcroft) or patients requiring apixaban dose reduction.\n9. Known hypersensitivity or other contraindications to aspirin (Hypersensitivity to aspirin or any of the excipients, history of asthma induced by the administration of salicylates, ongoing peptic ulcer, constitutional or acquired hemorrhagic disease including gastrointestinal bleeding, history of hemorrhagic stroke and thrombocytopenia, pregnancy after 24 weeks of gestation, risk of bleeding, severe renal failure, severe hepatic impairment, uncontrolled severe heart failure\n10. Known hypersensitivity or other contraindications to heparin or low molecular weight heparin (history of heparin-induced thrombocytopenia, hypersensitivity to any of the excipients…)\n11. Ischemic stroke within 1 month or intracranial hemorrhage\n12. Active endocarditis at the time of screening for enrollment.\n13. Women of childbearing potential without efficient contraception, pregnant or breastfeeding women.\n14. Concomitant combined strong P-gp and CYP3A4 inducers or inhibitors.\n15. History of non-compliance\n16. Participation in another interventional study\n17. Active cancer or life expectancy less than 1 year\n18. Persons deprived of their liberty by judicial or administrative decision","ALL","18 Years",{"count":72,"type":73},1500,"ESTIMATED","INTERVENTIONAL",[76],"PHASE3","DIAMOND study is a national, multicentre, randomized, parallel-group, open label study in patients (aged ≥18 years) with aortic bioprosthesis (excluding TAVI) at least 7 days after cardiac surgery.\n\nExperimental group:\n\nPatients treated with apixaban 5 mg twice daily (BID)\n\nActive Comparator group:\n\nAspirin 75 to 100mg once a day\n\nThe primary objective is to demonstrate that antithrombotic treatment with apixaban is superior to aspirin in patients with recent surgical bioprosthetic aortic valve replacement for the primary composite efficacy endpoint of death from any cause, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis after 105 days of follow-up.",[79],"Aortic Valve Disease",[81,82,83,84,85,86],"Anticoagulant","Aortic valve","Apixaban","Aspirin","Stroke","Hemorrhage","NOT_YET_RECRUITING","2025-06-09",{"date":90,"type":91},"2025-06-12","ACTUAL",{"date":93,"type":73},"2025-09",{"date":95,"type":73},"2029-03",{"name":5,"class":6},1]