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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.

Cardiology Division, Cardiovascular Research Institute, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea. Division of Cardiology, Keimyung University Dongsan Medical Center, Daegu, South Korea. Division of Cardiology, Department of Internal Medicine, Kyung Hee University, Seoul, South Korea. Division of Cardiology, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, South Korea. Division of Cardiology, Department of Internal Medicine, Chung-Ang University, Seoul, South Korea. Division of Cardiology, Sanggye-Paik Hospital, Inje University, Seoul, South Korea. Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, South Korea. Division of Cardiology, Heart Center, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea. Department of Cardiovascular Medicine, Gachon University Gil Medical Center, Incheon, South Korea. Division of Cardiology, Department of Internal Medicine, Ewha Womans University, Seoul, South Korea.

Frontiers in cardiovascular medicine. 2021;:765081
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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.