{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T17:54:49Z","timestamp":1792691689893,"version":"4.5.0"},"reference-count":23,"publisher":"SAGE Publications","issue":"10","license":[{"start":{"date-parts":[[2023,7,4]],"date-time":"2023-07-04T00:00:00Z","timestamp":1688428800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2023,7,4]],"date-time":"2023-07-04T00:00:00Z","timestamp":1688428800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"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":["International Journal of Stroke"],"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>The optimal timing of initiating or resuming anticoagulation after acute ischemic stroke (AIS) or transient ischemic attack (TIA) in patients with atrial fibrillation (AF) is debated. Dabigatran, a non-vitamin K oral anticoagulant (NOAC), has shown superiority against vitamin K antagonists (VKA) regarding hemorrhagic complications.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims:<\/jats:title>\n                    <jats:p>In this registry study, we investigated the initiation of dabigatran in the early phase after AIS or TIA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>PRODAST (Prospective Record of the Use of Dabigatran in Patients with Acute Stroke or TIA) is a prospective, multicenter, observational, post-authorization safety study. We recruited 10,039 patients at 86 German stroke units between July 2015 and November 2020. A total of 3,312 patients were treated with dabigatran or VKA and were eligible for the analysis that investigates risks for major hemorrhagic events within 3 months after early (\u2a7d\u20097\u2009days) or late (&gt;\u20097\u2009days) initiation of dabigatran or VKA initiated at any time. Further endpoints were recurrent stroke, ischemic stroke, TIA, systemic embolism, myocardial infarction, death, and a 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>Major bleeding event rates per 10,000 treatment days ranged from 1.9 for late administered dabigatran to 4.9 for VKA. Early or late initiation of dabigatran was associated with a lower hazard for major hemorrhages as compared to VKA use. The difference was pronounced for intracranial hemorrhages with an adjusted hazard ratio (HR) of 0.47 (95% confidence interval (CI): 0.10\u20132.21) for early dabigatran use versus VKA use and an adjusted HR of 0.09 (95% CI: 0.00\u201313.11) for late dabigatran use versus VKA use. No differences were found between early initiation of dabigatran versus VKA use regarding ischemic endpoints.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>The early application of dabigatran appears to be safer than VKA administered at any time point with regards to the risk of hemorrhagic complications and in particular for intracranial hemorrhage. This result, however, must be interpreted with caution in view of the low precision of the estimate.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17474930231184366","type":"journal-article","created":{"date-parts":[[2023,6,12]],"date-time":"2023-06-12T09:16:06Z","timestamp":1686561366000},"page":"1169-1177","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":16,"title":["Early or late initiation of dabigatran versus vitamin-K-antagonists in acute ischemic stroke or TIA: The PRODAST study"],"prefix":"10.1177","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5335-9880","authenticated-orcid":false,"given":"Gerrit M","family":"Grosse","sequence":"first","affiliation":[{"name":"Department of Neuroepidemiology, Institute for Medical Informatics, Biometry and Epidemiology, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany"},{"name":"Department of Neurology, Hannover Medical School, Hannover, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anika","family":"H\u00fcsing","sequence":"additional","affiliation":[{"name":"Department of Neuroepidemiology, Institute for Medical Informatics, Biometry and Epidemiology, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Stang","sequence":"additional","affiliation":[{"name":"Department of Neuroepidemiology, Institute for Medical Informatics, Biometry and Epidemiology, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany"},{"name":"Department of Epidemiology, School of Public Health, Boston University, Boston, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nils","family":"Kuklik","sequence":"additional","affiliation":[{"name":"Department of Neuroepidemiology, Institute for Medical Informatics, Biometry and Epidemiology, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcus","family":"Brinkmann","sequence":"additional","affiliation":[{"name":"Department of Neuroepidemiology, Institute for Medical Informatics, Biometry and Epidemiology, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany"},{"name":"Center for Clinical Trials Essen, University Hospital Essen, Essen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darius","family":"Nabavi","sequence":"additional","affiliation":[{"name":"Department of Neurology, Vivantes Klinikum Neuk\u00f6lln, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Sparenberg","sequence":"additional","affiliation":[{"name":"Department of Neurology, BG Klinikum Unfallkrankenhaus Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1157-8938","authenticated-orcid":false,"given":"Karin","family":"Weissenborn","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hannover Medical School, Hannover, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0244-6116","authenticated-orcid":false,"given":"Klaus","family":"Gr\u00f6schel","sequence":"additional","affiliation":[{"name":"Department of Neurology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georg","family":"Royl","sequence":"additional","affiliation":[{"name":"Department of Neurology, University of L\u00fcbeck, L\u00fcbeck, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0286-8781","authenticated-orcid":false,"given":"Sven","family":"Poli","sequence":"additional","affiliation":[{"name":"Department of Neurology and Stroke, University of T\u00fcbingen, T\u00fcbingen, Germany"},{"name":"Hertie Institute for Clinical Brain Research, University of T\u00fcbingen, T\u00fcbingen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominik","family":"Michalski","sequence":"additional","affiliation":[{"name":"Department of Neurology, University of Leipzig, Leipzig, Germany"}],"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 &amp; Co. KG, Ingelheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Weimar","sequence":"additional","affiliation":[{"name":"Department of Neuroepidemiology, Institute for Medical Informatics, Biometry and Epidemiology, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany"},{"name":"BDH-Klinik Elzach, Elzach, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6556-8612","authenticated-orcid":false,"given":"Hans-Christoph","family":"Diener","sequence":"additional","affiliation":[{"name":"Department of Neuroepidemiology, Institute for Medical Informatics, Biometry and Epidemiology, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the PRODAST Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2023,7,4]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(18)30356-9"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.122.060666"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1177\/1747493019870651"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1177\/17474930211057722"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1177\/23969873221106043"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1177\/2396987319841187"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1161\/STR.0000000000000375"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1093\/europace\/euab065"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jstrokecerebrovasdis.2020.105169"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1177\/2396987318787124"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.115.008891"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1002\/ana.25844"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp-2018-318890"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.119.028118"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/suaa104"},{"key":"e_1_3_3_17_2","article-title":"Factor Xa inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in patients with atrial fibrillation","volume":"3","author":"Bruins Slot KMH","year":"2018","unstructured":"Bruins Slot KMH, Berge E. 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