{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,12]],"date-time":"2025-10-12T20:05:48Z","timestamp":1760299548950,"version":"3.37.3"},"reference-count":13,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2017,3,9]],"date-time":"2017-03-09T00:00:00Z","timestamp":1489017600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2017,3,9]],"date-time":"2017-03-09T00:00:00Z","timestamp":1489017600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2016,12,22]],"date-time":"2016-12-22T00:00:00Z","timestamp":1482364800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["clinicalkey.jp","clinicalkey.com","journalofarrhythmia.com","clinicalkey.es","clinicalkey.com.au","clinicalkey.fr","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Arrhythmia"],"published-print":{"date-parts":[[2017,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Rivaroxaban, a direct oral anticoagulant (DOAC), has become available for stroke prevention in patients with non\u2010valular atrial fibrillation (NVAF). However, little is known about its effectiveness and safety when prescribed by general practitioners in real\u2010life settings.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>GENERAL is a multicenter, prospective, non\u2010interventional observational study of patients receiving rivaroxaban for NVAF in daily clinical practice prescribed specifically by general practitioners. The target number of participating medical institutions is 500\u2013700 clinics with fewer than 20 beds and the target number of participants is 5000. The baseline clinical data, including antidementia medication and frailty, and follow\u2010up data including concomitant treatment and outcomes until September 2018 (maximum three years) will be collected. The primary efficacy endpoints will be stroke and\/or systemic embolism and the secondary endpoints will be major bleeding meeting the ISTH guidelines, non\u2010major and clinically relevant bleeding, onset of symptomatic stroke (ischemic\/hemorrhagic), systemic embolism, deep vein thrombosis\/pulmonary thromboembolism, myocardial infarction and\/or cardiovascular death, and systemic embolism. Based on the provided information, the event assessment committee will investigate the endpoint\u2010related events. The annual incidence and predictive factors for primary\/secondary endpoint will be investigated based on underlying disease, age, renal function, and CHADS<jats:sub>2<\/jats:sub>, CHA<jats:sub>2<\/jats:sub>DS<jats:sub>2<\/jats:sub>\u2010VASC, and HAS\u2010BLED scores using Cox regression. We will also compare the incidence of the primary\/secondary endpoint between the present study, EXPAND study, and FUSHIMI AF registry study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The results of this study are currently under investigation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This study will provide important information regarding the effectiveness and safety of rivaroxaban treatment in Japanese patients with NVAF among general practitioners.<\/jats:p><\/jats:sec>","DOI":"10.1016\/j.joa.2016.12.001","type":"journal-article","created":{"date-parts":[[2017,3,9]],"date-time":"2017-03-09T03:02:59Z","timestamp":1489028579000},"page":"297-301","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":3,"title":["Study design of GENERAL (general practitioners and embolism prevention in NVAF patients treated with rivaroxaban: Real\u2010life evidence): A multicenter prospective cohort study in primary care physicians to investigate the effectiveness and safety of rivaroxaban in Japanese patients with NVAF"],"prefix":"10.1002","volume":"33","author":[{"given":"Kengo","family":"Kusano","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masaharu","family":"Akao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hikari","family":"Tsuji","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kunihiko","family":"Matsui","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shinya","family":"Hiramitsu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yutaka","family":"Hatori","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hironori","family":"Odakura","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,3,9]]},"reference":[{"key":"e_1_2_10_2_2","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.1994.00420130036007"},{"key":"e_1_2_10_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.thromres.2004.11.025"},{"key":"e_1_2_10_4_2","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.167.13.1414"},{"key":"e_1_2_10_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2008.06.029"},{"key":"e_1_2_10_6_2","first-page":"226","article-title":"Real\u2010world characteristics of hospitalized frail elderly patients with atrial fibrillation: can we improve the current prescription of anticoagulants?","volume":"13","author":"Annoni G.","year":"2016","journal-title":"J Geriatr Cardiol: JGC"},{"key":"e_1_2_10_7_2","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.114.001573"},{"key":"e_1_2_10_8_2","doi-asserted-by":"publisher","DOI":"10.18553\/jmcp.2009.15.3.244"},{"key":"e_1_2_10_9_2","doi-asserted-by":"publisher","DOI":"10.1253\/circj.CJ-14-0344"},{"key":"e_1_2_10_10_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1009638"},{"key":"e_1_2_10_11_2","doi-asserted-by":"publisher","DOI":"10.1253\/circj.CJ-12-0454"},{"key":"e_1_2_10_12_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.285.22.2864"},{"key":"e_1_2_10_13_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehq278"},{"key":"e_1_2_10_14_2","doi-asserted-by":"publisher","DOI":"10.1378\/chest.10-0134"}],"container-title":["Journal of 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