Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490994
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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


Condition or disease Intervention/treatment Phase
Acute Heart Failure Drug: Rivaroxaban Drug: Warfarin + LMWH Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: warfarin vs. rivaroxaban
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 10, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : January 2020


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

Active Comparator: Warfarin
warfarin + enoxaparin
Drug: Warfarin + LMWH
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 Measures :
  1. the change of high sensitive troponin [ Time Frame: Baseline to 72 hours ]
    The maximum hsTn value change from baseline to during hospitalization


Secondary Outcome Measures :
  1. 1) the change of hish sensitive troponin [ Time Frame: 1) On admission, hospital day #2, hospital day #4, hospital day #7 or discharge, 1 month/6month after discharge ]
    1) The change from baseline in hsTn on Day2, day4, day7 (or discharge), and follow-up visits at 1 month, 6 months

  2. 2) the change of D-dimer [ Time Frame: 2) On admission, hospital day #2, hospital day #4, hospital day #7 or discharge, 1 month/6month after discharge ]
    2) D-dimer change from baseline during hospitalization (day2, day4, day7 or discharge) & follow-up visits at 1, 6 months

  3. 3) the change of NT-proBNP [ Time Frame: 3) On admission, hospital day #7 or discharge, 1 month/6month after discharge ]
    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. 4) bleeding event [ Time Frame: 4) On admission, hospital day #2, hospital day #4, hospital day #7 or discharge, 1 month/3month/6month after discharge ]
    4) Incidence proportion and rate of major/minor bleeding during the study

  5. 5) hospital stay [ Time Frame: 5) The duration of hospital stay, average 7 days ]
    5) Length of hospital stay

  6. 6) all-cause mortality [ Time Frame: 6) 6 months after hospitalization ]
    6) Incidence proportion of in-hospital all-cause death cases

  7. 7) all-cause hospitalization & mortality [ Time Frame: 7) 6 months after hospitalization ]
    7) Time to the first composite event of all-cause mortality or cardiovascular re-hospitalization



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490994


Contacts
Layout table for location contacts
Contact: Seok-Min Kang, MD 82-2-2228-8450 smkang@yuhs.ac

Locations
Layout table for location information
Korea, Republic of
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Seok-Min Kang, MD    82-2-2228-8450    smkang@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03490994     History of Changes
Other Study ID Numbers: 4-2017-0776
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Vitamin K
Warfarin
Rivaroxaban
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants