Rivaroxaban Once Daily Versus Dose-adjusted Vitamin K Antagonist on the Biomarkers in Acute Decompensated Heart Failure and Atrial Fibrillation (ROAD HF-AF)

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: Acute Heart Failure

Treatments: Drug: Warfarin + LMWH; Drug: Rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT03490994

4-2017-0776

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Hospitalized patients with a primary diagnosis of ADHF with AF One of the following criteria and LVEF ≤ 40% (at least 1 year before admission or admission)

1. dyspnea at rest
2. tachypnea; a respiratory rate > 20/min
3. rales
4. pulmonary edema on chest X-ray

Exclusion Criteria:

1. History of increased bleeding risk (like ROCKET AF exclusion criteria)
2. Contraindication to anti-coagulation therapy
3. ACS diagnosis
4. Hospitalization plan for PCI, coronary artery bypass graft surgery, other cardiac invasive interventions (e.g. catheter ablation, pacemaker, CRT, ICD implantation)
5. Currently on dual anti-platelet therapy (aspirin + ADP receptor antagonist) or single antiplatelet therapy with a novel AP (e.g. Ticagrelor, Prasugrel)
6. Cardiogenic shock (systolic blood pressure, SBP, < 80 mmHg)
7. Patients with CrCl < 30 ml/min using creatinine-based CKD-EPI equations
8. Elevated liver enzymes (3 times over upper reference limit) or liver cirrhosis
9. Uncontrolled hypertension (SBP > 180 mmHg)
10. Allergy, adverse drug reaction, hypersensitivity to rivaroxaban or warfarin
11. Life expectancy < 6 months (e.g. metastatic malignancy)
12. Pregnancy, or women of childbearing age

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Rivaroxaban

Experimental group

Description:

Rivaroxaban

Treatment:

Drug: Rivaroxaban

Warfarin

Active Comparator group

Description:

warfarin + enoxaparin

Treatment:

Drug: Warfarin + LMWH