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Acute Heart FailurePhase 4NCT03490994

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

A Phase 4 study testing Rivaroxaban and Warfarin + LMWH in people with Acute Heart Failure, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Acute Heart Failure
What is being tested?
Rivaroxaban and Warfarin + LMWH
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteSouth Korea
Study dates
10 Apr 2018to Jan 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Seok-Min Kang, MD contact

82-2-2228-8450

smkang@yuhs.ac

South Korea1 site, 1 recruiting

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

    Seoul, 120-752

    Seok-Min Kang, MD, 82-2-2228-8450, smkang@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

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

Being tested
Rivaroxaban, Warfarin + LMWH

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RivaroxabanDrug

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

  • Warfarin + LMWHDrug

    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

Study groups in NCT03490994
Study groupRoleWhat they receive
RivaroxabanExperimentalRivaroxaban
Receives: Drug: Rivaroxaban
WarfarinActive comparatorwarfarin + enoxaparin
Receives: Drug: Warfarin + LMWH

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the change of high sensitive troponin

    The maximum hsTn value change from baseline to during hospitalization

    Measured: Baseline to 72 hours

Secondary outcomes (7)

  1. 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

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

  2. 2) the change of D-dimer

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

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

  3. 3) the change of NT-proBNP

    1. 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

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

  4. 4) bleeding event

    1. Incidence proportion and rate of major/minor bleeding during the study

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

  5. 5) hospital stay

    1. Length of hospital stay

    Measured: 5) The duration of hospital stay, average 7 days

  6. 6) all-cause mortality

    1. Incidence proportion of in-hospital all-cause death cases

    Measured: 6) 6 months after hospitalization

  7. 7) all-cause hospitalization & mortality

    1. Time to the first composite event of all-cause mortality or cardiovascular re-hospitalization

    Measured: 7) 6 months after hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2018
  2. Study start10 Apr 2018
  3. Primary completionSep 2019 (estimated)
  4. Study completionJan 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
warfarin vs. rivaroxaban
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03490994
Sponsor's protocol ID
4-2017-0776
Status last verified
Jan 2019
First submitted
11 Mar 2018
Last updated
10 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rivaroxaban and Warfarin + LMWH in people with Acute Heart Failure, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Seok-Min Kang, MD (82-2-2228-8450, smkang@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the change of high sensitive troponin (time frame: Baseline to 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03490994.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.

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