[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444039":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":59,"collaborators":63,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":26,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":26,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Odense University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Continuance","ACTIVE_COMPARATOR","Continuance prior statin therapy.",[13],"Drug: No-intervention.",{"label":15,"type":16,"description":17,"interventionNames":18},"Discontinuance","EXPERIMENTAL","Discontinuance prior statin therapy. Duration: From 7 to 14 days prior to surgery until 30 days postoperative",[19],"Drug: Discontinuance of treatment with statins 7 to 14 days prior to surgery until 30 days postoperative",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Discontinuance of treatment with statins 7 to 14 days prior to surgery until 30 days postoperative","Discontinuance of prior statin therapy",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"No-intervention.","Continuance of prior statin therapy",[9],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Lytfi Krasniqi, MD","CONTACT","+4542772085","Lytfi.krasniqi@rsyd.dk",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Lars Riber, MD","21450354","lars.riber@rsyd.dk",[42],{"facility":5,"status":43,"city":44,"state":26,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Odense","5000","Denmark","DK",{"type":49,"coordinates":50},"Point",[51,52],10.38831,55.39594,{"lat":52,"lon":51},[55],{"name":33,"role":34,"phone":56,"phoneExt":57,"email":58},"42772085","0045","Lytfi.Krasniqi@rsyd.dk",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Lars Peter Riber","MD, Associate Professor, Ph.D., DMSc",[64,66],{"name":65,"class":6},"Odense Patient Data Explorative Network",{"name":67,"class":68},"GCP-unit at Odense University Hospital","UNKNOWN","100444039","post-operative-atrial-fibrillation-after-surgical-aortic-valve-replacement-and-the-influence-of-statins-100444039",false,"NCT05062239","Post-Operative Atrial Fibrillation After Surgical Aortic Valve Replacement and the Influence of Statins","Post-Operative Atrial Fibrillation After Surgical Aortic Valve Replacement and the Influence of Statins - Randomized Controlled Trial","Inclusion Criteria:\n\n1. Patients undergoing elective solitary SAVR with bioprosthesis\n2. Patients who are in sinus rhythm and not taking any anti-arrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery\n3. In treatment with HMG-CoA reductase inhibitors in the past 3 months and of at least 7 days\n4. Age \\>60 years\n5. Willingness and provision of informed consent to be randomized\n\nExclusion Criteria:\n\n1. Prior history of atrial fibrillation\n2. Prior history of cardiac surgery\n3. Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit)\n4. Creatinine \\>200 µmol\u002FL","ALL","60 Years","95 Years",{"count":80,"type":81},100,"ESTIMATED","INTERVENTIONAL",[84],"NA","Statins have rapid and significant actions that have potentially important (but not yet proven) implications for postoperative atrial fibrillation and cardiac protection in patients undergoing cardiac surgery.\n\nThe focus of this study is, therefore, on patients having surgical aortic valve replacement (with aortotomy) and the development of postoperative atrial fibrillation (POAF).\n\nOur aims are: to investigate the risk of POAF, infection or other complications after SAVR in continuous versus preoperative discontinuous treatment with statins.\n\nThe study is a single centre randomized controlled trial with continuance treatment with statin vs. discontinuance (7 to 14 days prior surgery until the 30th post-operative day included), on patients undergoing elective solitary SAVR with bioprosthesis with prior usage of statins the last 3 months and of at least 7 days.\n\nThis randomized studies will address 2 separate hypotheses in patients undergoing open heart operation with solitary aortic valve replacement with a bioprosthetic valve that\n\n1. Discontinuation of HMG-CoA reductase inhibitors 7 to 14 days preoperative until 30 days postoperative of AVR in patients with prior use of HMG-CoA reductase inhibitors is not associated with increased early (\\\u003C30 days) risk of POAF.\n2. Discontinuation of HMG-CoA reductase inhibitors 7 to 14 days preoperative until 30 days postoperative of AVR in patients with prior use of HMG-CoA reductase inhibitors is not associated with increased early (\\\u003C30 days) and intermediate (\\\u003C1 year) risk of mortality, MI, stroke and rehospitalisation.",[87],"Postoperative Atrial Fibrillation","2025-04-22",{"date":90,"type":91},"2025-04-23","ACTUAL",{"date":93,"type":91},"2022-04-01",{"date":95,"type":81},"2027-02-01",{"name":61,"class":6},1]