[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529022":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":45,"collaborators":49,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":32,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"St. Antonius Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CT guided strategy","EXPERIMENTAL","The intervention group will undergo CT scan after 3 months. If subclinical valve thrombosis is detected, anticoagulation will be started. If no subclinical valve thrombosis is detected, the SAPT is stopped, unless another indication is present.",[13],"Radiation: CT guided strategy",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard care","NO_INTERVENTION","Standard of care with lifelong SAPT after TAVI",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"RADIATION","1. With signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI are switched from SAPT to apixaban. Patients fulfilling the dose reduction criteria according to the drug label, or with a Clinical Frailty Scale ≥4 will receive 2.5mg bid, patients not meeting these criteria will receive a standard dose of 5mg bid.\n2. Without signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI, without another indication for antiplatelet therapy stop their SAPT.\n3. Without signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI with another indication for antiplatelet therapy continue life-long SAPT.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Christiaan Overduin","CONTACT","+31883200931","c.overduin@antoniusziekenhuis.nl",[31],{"facility":5,"status":32,"city":33,"state":18,"zip":18,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"RECRUITING","Nieuwegein","Netherlands","NL",{"type":37,"coordinates":38},"Point",[39,40],5.08056,52.02917,{"lat":40,"lon":39},[43],{"name":44,"role":27,"phone":18,"phoneExt":18,"email":18},"Jurrien ten berg, MD PhD",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Jurriën M. ten Berg, MD, PhD","Clinical Professor",[50,52],{"name":51,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development",{"name":53,"class":6},"Pitié-Salpêtrière Hospital","100529022","personalized-ct-guided-antithrombotic-therapy-versus-lifelong-single-antiplatelet-therapy-to-reduce-thromboembolic-and-bleeding-events-in-non-atrial-fibrillation-patients-after-transcatheter-aortic-valve-implantation-100529022",false,"NCT06168370","Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation","Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation: a Pragmatic, International, Multicentre, Randomized Clinical Trial","POP ATLANTIS","Inclusion Criteria:\n\n* Successful TAVI (according to the VARC-3 criteria)10 with any approved device\n* Ability to understand and to comply with the study protocol\n* Written informed consent\n\nExclusion Criteria:\n\n* Existing indication for oral anticoagulation (e.g. atrial fibrillation, obstructive valve thrombosis detected by echocardiography prior to inclusion)\n* Existing indication for dual antiplatelet therapy at three months after TAVI (rare at this time point)\n* Creatinine clearance \\\u003C15 mL\u002Fmin (based on the CKD-EPI formula) or on renal replacement therapy","ALL","18 Years","110 Years",{"count":66,"type":67},2500,"ESTIMATED","INTERVENTIONAL",[70],"NA","The POPular ATLANTIS trial aims to investigate CT-guided antithrombotic therapy compared to lifelong single antiplatelet therapy after a transcatheter aortic valve implantation (TAVI) procedure. Only patients without an indication for anticoagulants will be included in this trial. Currently, lifelong single antiplatelet therapy (mostly aspirin) is considered the standard of care for these patients. However, this approach poses a bleeding risk with only a minimal reduction in thromboembolic events.\n\nAfter 3 months, a CT scan will be conducted to assess the presence of thrombosis on the newly implanted TAVI valve. Based on the results of a 4D CT scan, the decision will be made whether the patient should receive no anticoagulant or antithrombotic therapy with apixaban. CT-guided antithrombotic therapy holds the potential for a greater reduction in thromboembolic events without increasing the bleeding risk.",[73],"Severe Aortic Valve Stenosis",[75,76,77,78,79,80],"aortic stenosis","bleeding","tavi","ct","personalized antithrombotic therapy","tavr","2026-05-18",{"date":83,"type":84},"2026-05-19","ACTUAL",{"date":86,"type":84},"2023-12-01",{"date":88,"type":67},"2028-12-01",{"name":5,"class":6},1]