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Rivaroxaban Once-Daily vs. Dose-Adjusted Vitamin K Antagonist on Biomarkers in Acute Decompensated Heart Failure and Atrial Fibrillation (ROAD HF-AF): Rationale and Design of an Investigator-Initiated Multicenter Randomized Prospective Open-Labeled Pilot Clinical Study
DC Field | Value | Language |
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dc.contributor.author | 강석민 | - |
dc.contributor.author | 오재원 | - |
dc.contributor.author | 조익성 | - |
dc.contributor.author | 최의영 | - |
dc.date.accessioned | 2022-03-11T06:11:34Z | - |
dc.date.available | 2022-03-11T06:11:34Z | - |
dc.date.issued | 2022-01 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/187979 | - |
dc.description.abstract | Background: Clinical trials of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with chronic heart failure and atrial fibrillation (AF) have demonstrated reduced risks of stroke and bleeding compared with vitamin K antagonists (VKAs). Here, we aim to assess the clinical efficacy and safety of rivaroxaban, a NOAC, compared with warfarin, a VKA, and the effects of rivaroxaban on cardiovascular biomarkers in patients with acute decompensated heart failure (ADHF) with reduced ejection fraction (≤40%) and AF. Methods: Rivaroxaban Once-daily vs. dose-adjusted vitamin K antagonist on biomarkers in Acute Decompensated Heart Failure and Atrial Fibrillation (ROAD HF-AF) is a randomized, open-labeled, controlled, prospective, multicenter pilot study designed to assess cardiovascular biomarkers and the safety of rivaroxaban (20 or 15 mg in patients with creatinine clearance 30-49 mL/min per day) compared with VKA (target international normalized range: 2-3) in 150 patients hospitalized with ADHF and AF. The primary endpoint is the change in circulating high-sensitivity cardiac troponin (hsTn) during hospitalization. The secondary endpoints are bleeding, hospital stay duration, in-hospital mortality, and changes in cardiovascular, renal, and thrombosis biomarkers. Patients will be followed for 180 days. Conclusion: We hypothesize that rivaroxaban will reduce myocardial injury and hemodynamic stress, as reflected by the biomarker status, within 72 h in patients with ADHF and AF, compared with VKA. We hope to facilitate future biomarker-based, large-scale outcome trials using NOACs in patients with ADHF and AF, based on the results of this multicenter, randomized, controlled study. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Frontiers Media S.A. | - |
dc.relation.isPartOf | FRONTIERS IN CARDIOVASCULAR MEDICINE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | Rivaroxaban Once-Daily vs. Dose-Adjusted Vitamin K Antagonist on Biomarkers in Acute Decompensated Heart Failure and Atrial Fibrillation (ROAD HF-AF): Rationale and Design of an Investigator-Initiated Multicenter Randomized Prospective Open-Labeled Pilot Clinical Study | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Iksung Cho | - |
dc.contributor.googleauthor | Jaewon Oh | - |
dc.contributor.googleauthor | In-Cheol Kim | - |
dc.contributor.googleauthor | Hyemoon Chung | - |
dc.contributor.googleauthor | Jung-Hee Lee | - |
dc.contributor.googleauthor | Hyue Mee Kim | - |
dc.contributor.googleauthor | Young Sup Byun | - |
dc.contributor.googleauthor | Byung-Su Yoo | - |
dc.contributor.googleauthor | Eui-Young Choi | - |
dc.contributor.googleauthor | Wook-Jin Chung | - |
dc.contributor.googleauthor | Wook Bum Pyun | - |
dc.contributor.googleauthor | Seok-Min Kang | - |
dc.identifier.doi | 10.3389/fcvm.2021.765081 | - |
dc.contributor.localId | A00037 | - |
dc.contributor.localId | A02395 | - |
dc.contributor.localId | A03888 | - |
dc.contributor.localId | A04165 | - |
dc.relation.journalcode | J04002 | - |
dc.identifier.eissn | 2297-055X | - |
dc.identifier.pmid | 35096995 | - |
dc.subject.keyword | acute decompensated heart failure | - |
dc.subject.keyword | atrial fibrillation | - |
dc.subject.keyword | biomarker | - |
dc.subject.keyword | rivaroxaban | - |
dc.subject.keyword | vitamin K antagonist (VKA) | - |
dc.contributor.alternativeName | Kang, Seok Min | - |
dc.contributor.affiliatedAuthor | 강석민 | - |
dc.contributor.affiliatedAuthor | 오재원 | - |
dc.contributor.affiliatedAuthor | 조익성 | - |
dc.contributor.affiliatedAuthor | 최의영 | - |
dc.citation.volume | 8 | - |
dc.citation.startPage | 765081 | - |
dc.identifier.bibliographicCitation | FRONTIERS IN CARDIOVASCULAR MEDICINE, Vol.8 : 765081, 2022-01 | - |
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