Acute Heart Failure Clinical Trial
Official title:
Rivaroxaban Once Daily Versus Dose-adjusted Vitamin K Antagonist on the Biomarkers in Acute Decompensated Heart Failure and Atrial Fibrillation (ROAD HF-AF)
Vitamin K antagonists (VKAs) are used to reduce the risk of stroke (cerebral vascular
dysfunction) in AF patients. However, VKAs interact with drugs/food and the drug level is
influenced by worsening of renal function, liver congestion or hemodynamic alterations in
acute decompensated heart failure (ADHF). New oral anticoagulants (rivaroxaban, apixaban,
dabigatran) are alternatives to VKA, such as warfarin. In post hoc analysis of ROCKET AF
trial, 63.7% patients had HF and treatment-related outcomes were similar in patients with and
without HF (Circulation HF. 2013; 6:740-7). So rivaroxaban 20 mg daily (or 15 mg daily in
patients with creatinine clearance 30-49 mL/min) was safe in nonvalvular AF patients with HF.
However, the clinical effect and safety of rivaroxaban were largely unknown in acute
decompensated heart failure (ADHF) patients with atrial fibrillation (AF).
ROAD HF-AF is the exploratory study to assess the change of surrogate markers (hsTn, d-dimer)
when treated with rivaroxaban vs. warfarin and to strengthen the basis for future
biomarker-based therapy in ADHF patients
n/a
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