{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T21:17:05Z","timestamp":1780435025774,"version":"3.54.1"},"reference-count":18,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2025,12,13]],"date-time":"2025-12-13T00:00:00Z","timestamp":1765584000000},"content-version":"vor","delay-in-days":468,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2024,9,1]],"date-time":"2024-09-01T00:00:00Z","timestamp":1725148800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2024,9,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction:<\/jats:title>\n                    <jats:p>Factor Xa (FXa) inhibitors are superior to vitamin K antagonists (VKAs) in terms of avoiding hemorrhagic complications. However, no robust data are available to date as to whether this also applies to the early phase after stroke. In this prospective registry study, we aimed to investigate whether anticoagulation with FXa inhibitors in the early phase after acute ischemic stroke or transient ischemic attack (TIA) is associated with a lower risk of major bleeding events compared with VKAs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and methods:<\/jats:title>\n                    <jats:p>The Prospective Record of the Use of Dabigatran in Patients with Acute Stroke or TIA (PRODAST) study is a prospective, multicenter, observational, post-authorization safety study at 86 German stroke units between July 2015 and November 2020. Primary outcome was a major bleeding event during hospital stay. Secondary endpoints were recurrent strokes, recurrent ischemic strokes, TIA, systemic\/pulmonary embolism, myocardial infarction, death and the composite endpoint of stroke, systemic embolism, life-threatening bleeding and death.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>In total, 10,039 patients have been recruited. 5,874 patients were treated with FXa inhibitors and 1,050 patients received VKAs and were eligible for this analysis. Overall, event rates were low. We observed 49 major bleeding complications during 33,297 treatment days with FXa-inhibitors (rate of 14.7 cases per 10,000 treatment days) and 16 cases during 7,714 treatment days with VKAs (rate of 20.7 events per 10,000 treatment days), translating into an adjusted hazard ratio (aHR) of 0.70 (95% confidence interval (95% CI): 0.37\u20131.32) in favor of FXa inhibitors. Hazards for ischemic endpoints (63 vs 17 strokes, aHR: 0.96 (95% CI: 0.53\u20131.74), mortality (33 vs 6 deaths, aHR: 0.87 (95% CI: 0.33\u20132.34)) and the combined endpoint (154 vs 39 events, aHR: 0.99 (95% CI: 0.65\u20131.41) were not substantially different.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion and conclusion:<\/jats:title>\n                    <jats:p>This large real-world study shows that FXa inhibitors appear to be similarly effective in terms of bleeding events and ischemic endpoints compared to VKAs in the early post-stroke phase of hospitalization. However, the results need to be interpreted with caution due to the low precision of the estimates.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/23969873241242239","type":"journal-article","created":{"date-parts":[[2024,4,3]],"date-time":"2024-04-03T07:12:42Z","timestamp":1712128362000},"page":"696-703","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["Efficacy and safety of oral factor Xa inhibitors versus vitamin-K antagonists in the early phase after acute ischemic stroke or TIA in the real-world setting: The PRODAST study"],"prefix":"10.1093","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6556-8612","authenticated-orcid":false,"given":"Hans-Christoph","family":"Diener","sequence":"first","affiliation":[{"name":"Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany 1"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5335-9880","authenticated-orcid":false,"given":"Gerrit M","family":"Grosse","sequence":"additional","affiliation":[{"name":"Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany 1"},{"name":"Department of Neurology, Hannover Medical School, Hannover, Germany 2"},{"name":"Department of Neurology and Stroke Center, University Hospital Basel, Basel, Switzerland 3"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anika","family":"H\u00fcsing","sequence":"additional","affiliation":[{"name":"Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany 1"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Stang","sequence":"additional","affiliation":[{"name":"Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany 1"},{"name":"School of Public Health, Department of Epidemiology Boston University, Boston, MA, United States of America 4"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nils","family":"Kuklik","sequence":"additional","affiliation":[{"name":"Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany 1"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcus","family":"Brinkmann","sequence":"additional","affiliation":[{"name":"Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University Duisburg-Essen, Essen, Germany 1"},{"name":"Center for Clinical Trials Essen, University Hospital Essen, Essen, Germany 5"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriele D","family":"Maurer","sequence":"additional","affiliation":[{"name":"Department of Neurology, University Hospital Frankfurt, Goethe University Frankfurt, Germany 6"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hassan","family":"Soda","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Akutneurologie mit \u00dcberregionaler Stroke Unit, Klinischer Neurophysiologie und Intensivmedizin, Rh\u00f6n-Klinikum Campus Bad Neustadt, Bad Neustadt, Germany 7"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carsten","family":"Pohlmann","sequence":"additional","affiliation":[{"name":"Department of Neurology, Asklepios Klinik Barmbek, Hamburg, Germany 8"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R\u00fcdiger","family":"Hilker-Roggendorf","sequence":"additional","affiliation":[{"name":"Department of Neurology, Klinikum Vest, Recklinghausen 9"},{"name":"Ruhr-University, Bochum, Germany 10"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikola","family":"Popovic","sequence":"additional","affiliation":[{"name":"Department of Neurology, Evangelisches Krankenhaus Hattingen, Hattingen, Germany 11"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Kraft","sequence":"additional","affiliation":[{"name":"Klinikum Main-Spessart Lohr, Germany 12"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno-Marcel","family":"Mackert","sequence":"additional","affiliation":[{"name":"Department of Neurology, Vivantes Auguste-Viktoria Hospital, Berlin, Germany 13"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2766-2488","authenticated-orcid":false,"given":"Christoph C","family":"Eschenfelder","sequence":"additional","affiliation":[{"name":"Human Pharma Germany, Boehringer Ingelheim Pharma GmbH & Co. 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