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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | Experimental | Rivaroxaban |
|
| Warfarin | Active Comparator | warfarin + enoxaparin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban | Drug | Rivaroxaban 20mg qd (15mg qd when CrCl 30-49 ml/min using creatinine-based CKD-EPI equations) for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| the change of high sensitive troponin | The maximum hsTn value change from baseline to during hospitalization | Baseline to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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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)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seok-Min Kang, MD | Contact | 82-2-2228-8450 | smkang@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine | Recruiting | Seoul | 120-752 | South Korea |
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warfarin vs. rivaroxaban
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| 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 |
|
2) D-dimer change from baseline during hospitalization (day2, day4, day7 or discharge) & follow-up visits at 1, 6 months |
| 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) 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 | 3) On admission, hospital day #7 or discharge, 1 month/6month after discharge |
| 4) bleeding event | 4) Incidence proportion and rate of major/minor bleeding during the study | 4) On admission, hospital day #2, hospital day #4, hospital day #7 or discharge, 1 month/3month/6month after discharge |
| 5) hospital stay | 5) Length of hospital stay | 5) The duration of hospital stay, average 7 days |
| 6) all-cause mortality | 6) Incidence proportion of in-hospital all-cause death cases | 6) 6 months after hospitalization |
| 7) all-cause hospitalization & mortality | 7) Time to the first composite event of all-cause mortality or cardiovascular re-hospitalization | 7) 6 months after hospitalization |
| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D014859 | Warfarin |
| D006495 | Heparin, Low-Molecular-Weight |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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