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

Primary Purpose

Acute Heart Failure

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Rivaroxaban

Warfarin + LMWH

About this trial

This is an interventional treatment trial for Acute Heart Failure

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

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

Exclusion Criteria:

History of increased bleeding risk (like ROCKET AF exclusion criteria)
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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rivaroxaban

Warfarin

Arm Description

Rivaroxaban

warfarin + enoxaparin

Outcomes

Primary Outcome Measures

the change of high sensitive troponin

The maximum hsTn value change from baseline to during hospitalization

Secondary Outcome Measures

1) the change of hish sensitive troponin

1) The change from baseline in hsTn on Day2, day4, day7 (or discharge), and follow-up visits at 1 month, 6 months

2) the change of D-dimer

2) D-dimer change from baseline during hospitalization (day2, day4, day7 or discharge) & follow-up visits at 1, 6 months

3) the change of NT-proBNP

3) TAT complex, PAI-1, hsCRP, NT-proBNP, sST2, galectin-3, cystatin C, NGAL, NAG change from baseline to day7 or discharge & 1,6 months after discharge

4) bleeding event

4) Incidence proportion and rate of major/minor bleeding during the study

5) hospital stay

5) Length of hospital stay

6) all-cause mortality

6) Incidence proportion of in-hospital all-cause death cases

7) all-cause hospitalization & mortality

7) Time to the first composite event of all-cause mortality or cardiovascular re-hospitalization

Full Information

NCT ID

NCT03490994

First Posted

March 11, 2018

Last Updated

January 9, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03490994

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

April 10, 2018 (Actual)

Primary Completion Date

September 2019 (Anticipated)

Study Completion Date

January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

warfarin vs. rivaroxaban

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rivaroxaban

Arm Type

Experimental

Arm Description

Rivaroxaban

Arm Title

Warfarin

Arm Type

Active Comparator

Arm Description

warfarin + enoxaparin

Intervention Type

Drug

Intervention Name(s)

Rivaroxaban

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Warfarin + LMWH

Intervention Description

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

Primary Outcome Measure Information:

Title

the change of high sensitive troponin

Description

The maximum hsTn value change from baseline to during hospitalization

Time Frame

Baseline to 72 hours

Secondary Outcome Measure Information:

Title

1) the change of hish sensitive troponin

Description

1) The change from baseline in hsTn on Day2, day4, day7 (or discharge), and follow-up visits at 1 month, 6 months

Time Frame

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

Title

2) the change of D-dimer

Description

2) D-dimer change from baseline during hospitalization (day2, day4, day7 or discharge) & follow-up visits at 1, 6 months

Time Frame

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

Title

3) the change of NT-proBNP

Description

3) TAT complex, PAI-1, hsCRP, NT-proBNP, sST2, galectin-3, cystatin C, NGAL, NAG change from baseline to day7 or discharge & 1,6 months after discharge

Time Frame

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

Title

4) bleeding event

Description

4) Incidence proportion and rate of major/minor bleeding during the study

Time Frame

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

Title

5) hospital stay

Description

5) Length of hospital stay

Time Frame

5) The duration of hospital stay, average 7 days

Title

6) all-cause mortality

Description

6) Incidence proportion of in-hospital all-cause death cases

Time Frame

6) 6 months after hospitalization

Title

7) all-cause hospitalization & mortality

Description

7) Time to the first composite event of all-cause mortality or cardiovascular re-hospitalization

Time Frame

7) 6 months after hospitalization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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) dyspnea at rest tachypnea; a respiratory rate > 20/min rales pulmonary edema on chest X-ray Exclusion Criteria: History of increased bleeding risk (like ROCKET AF exclusion criteria) 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Seok-Min Kang, MD

Phone

82-2-2228-8450

smkang@yuhs.ac

Facility Information:

Facility Name

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

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Seok-Min Kang, MD

Phone

82-2-2228-8450

smkang@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD

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

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