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

NCT ID: NCT03490994

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-10
• Study Completion Date: 2020-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rivaroxaban

Rivaroxaban

Group Type: EXPERIMENTAL

Rivaroxaban

Intervention Type: DRUG

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

Warfarin

warfarin + enoxaparin

Group Type: ACTIVE_COMPARATOR

Warfarin + LMWH

Intervention Type: 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

Interventions

Rivaroxaban

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. dyspnea at rest

2. tachypnea; a respiratory rate > 20/min

3. rales

4. pulmonary edema on chest X-ray

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Seok-Min Kang, MD

Role: CONTACT

smkang@yuhs.ac

82-2-2228-8450

Facility Contacts

Seok-Min Kang, MD

Role: primary

smkang@yuhs.ac

82-2-2228-8450

Other Identifiers

4-2017-0776

Identifier Type: -

Identifier Source: org_study_id