{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,25]],"date-time":"2026-04-25T19:18:31Z","timestamp":1777144711328,"version":"3.51.4"},"reference-count":46,"publisher":"BMJ","issue":"5","license":[{"start":{"date-parts":[[2023,5,9]],"date-time":"2023-05-09T00:00:00Z","timestamp":1683590400000},"content-version":"unspecified","delay-in-days":8,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100006356","name":"University of Southern Denmark","doi-asserted-by":"crossref","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}],"id":[{"id":"10.13039\/501100006356","id-type":"DOI","asserted-by":"crossref"}]},{"name":"The Region of Southern Denmark","award":["A1126"],"award-info":[{"award-number":["A1126"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,4,27]]},"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Atrial fibrillation (AF) is the most common postoperative complication after surgical aortic valve replacement (SAVR) and occurs in up to 50% of the patients. Development of postoperative AF (POAF) is associated with a 2\u20133 fold increased risk of adverse events, including stroke, myocardial infarction and death.<\/jats:p>\n                    <jats:p>Several studies have implied that prophylactic Atorvastatin therapy could prevent POAF in patients undergoing coronary artery bypass graft. These studies suggest that Atorvastatin has rapid and significant pleiotropic actions that reduce the risk of POAF. However, prophylactic treatment with statins has yet to be understood in SAVR. The aim of this study is to investigate whether prophylactic administration of torvastatin reduces POAF in patients undergoing SAVR.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>In this investigator-initiated, prospective, parallel-group, randomised, double-blind, placebo-controlled single-centre trial, 266 patients undergoing elective solitary SAVR with bioprosthetic valve, with no prior history of AF, and statin-na\u00efve will be randomised (1:1) to treatment with Atorvastatin (80\u2009mg once daily) or matching placebo for 1\u20132 weeks prior to and 30 days after surgery. The primary endpoint is POAF defined as an episode of irregular RR-intervals without a traceable p-wave of at least 30\u2009s duration. After discharge and until day 30 after surgery, POAF will be documented by either rhythm strip or 12-lead ECG.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Protocol approval has been obtained from the Regional Scientific Ethical Committee for Southern Denmark (S-20210159), The Danish Medicines Agency (2021103821) and the Data Protection Agency (21\/65621).<\/jats:p>\n                    <jats:p>The trial is conducted in accordance with the Declaration of Helsinki, the ICH-GCP (International Conference on Harmonisation Good Clinical Practice) guidelines and the legal regulations of Denmark. Study findings will be shared via peer-reviewed journal publication and conference presentations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05076019\">NCT05076019<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-069595","type":"journal-article","created":{"date-parts":[[2023,5,10]],"date-time":"2023-05-10T13:19:54Z","timestamp":1683724794000},"page":"e069595","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Atorvastatin and the influence on postoperative atrial fibrillation after surgical aortic valve replacement (STARC) in adults at Odense University Hospital, Denmark: study protocol for a randomised controlled trial"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct05076019","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05076019","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8048-9779","authenticated-orcid":false,"given":"Lytfi","family":"Krasniqi","sequence":"first","affiliation":[{"name":"Department of Cardiac, Thoracic and Vascular Surgery, Odense University Hospital, Odense, Denmark"},{"name":"Department of Clinical Research, University of Southern Denmark, Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Axel","family":"Brandes","sequence":"additional","affiliation":[{"name":"Department of Clinical Research, University of Southern Denmark, Odense, Denmark"},{"name":"Cardiology, University of Southern Denmark - Campus Esbjerg, Esbjerg, Denmark"},{"name":"Department of Cardiology, Odense University Hospital, Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Poul Erik","family":"Mortensen","sequence":"additional","affiliation":[{"name":"Department of Cardiac, Thoracic and Vascular Surgery, Odense University Hospital, Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jordi Sanchez","family":"Dahl","sequence":"additional","affiliation":[{"name":"Department of Clinical Research, University of Southern Denmark, Odense, Denmark"},{"name":"Department of Cardiology, Odense University Hospital, Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6335-3303","authenticated-orcid":false,"given":"Oke","family":"Gerke","sequence":"additional","affiliation":[{"name":"Department of Clinical Research, University of Southern Denmark, Odense, Denmark"},{"name":"Department of Nuclear Medicine, Odense University Hospital, Odense, 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