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

NCT03490994 | Unknown Phase 4

• 1 other identifier: 4-2017-0776
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Heart Failure

Outcome Measures

Primary Outcomes (1)

• the change of high sensitive troponin

  The maximum hsTn value change from baseline to during hospitalization

  Baseline to 72 hours

Secondary Outcomes (7)

• 1) the change of hish sensitive troponin

  1) On admission, hospital day #2, hospital day #4, hospital day #7 or discharge, 1 month/6month after discharge

• 2) the change of D-dimer

  2) On admission, hospital day #2, hospital day #4, hospital day #7 or discharge, 1 month/6month after discharge

• 3) the change of NT-proBNP

  3) On admission, hospital day #7 or discharge, 1 month/6month after discharge

• 4) bleeding event

  4) On admission, hospital day #2, hospital day #4, hospital day #7 or discharge, 1 month/3month/6month after discharge

• 5) hospital stay

  5) The duration of hospital stay, average 7 days

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

Rivaroxaban

Drug: Rivaroxaban

Warfarin

ACTIVE COMPARATOR

warfarin + enoxaparin

Drug: Warfarin + LMWH

Interventions

Rivaroxaban DRUG

Rivaroxaban 20mg qd (15mg qd when CrCl 30-49 ml/min using creatinine-based CKD-EPI equations) for 6 months

Rivaroxaban

Warfarin + LMWH DRUG

dose-adjusted warfarin (target INR 2-3) for 6 months + LMWH (enoxaparin 1 mg/kg q12h for a few days until INR target achieved) if indicated

Warfarin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• dyspnea at rest
• tachypnea; a respiratory rate \> 20/min
• rales
• pulmonary edema on chest X-ray

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Interventions

Rivaroxaban; Warfarin; Heparin, Low-Molecular-Weight

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Seok-Min Kang, MD

CONTACT

82-2-2228-8450; smkang@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: warfarin vs. rivaroxaban

Study Record Dates

• First Submitted: March 11, 2018
• First Posted: April 6, 2018
• Study Start: April 10, 2018
• Primary Completion: September 1, 2019
• Study Completion: January 1, 2020
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)