Rivaroxaban Once Daily Versus Dose-adjusted Vitamin K Antagonist on the Biomarkers in Acute Decompensated Heart Failure and Atrial Fibrillation (ROAD HF-AF)
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- the change of high sensitive troponin
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •pulmonary edema on chest X-ray
排除标准
- •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
研究组 & 干预措施
Rivaroxaban
Rivaroxaban
干预措施: Rivaroxaban (Drug)
Warfarin
warfarin + enoxaparin
干预措施: Warfarin + LMWH (Drug)
结局指标
主要结局
the change of high sensitive troponin
时间窗: Baseline to 72 hours
The maximum hsTn value change from baseline to during hospitalization
次要结局
- 3) the change of NT-proBNP(3) On admission, hospital day #7 or discharge, 1 month/6month after discharge)
- 5) hospital stay(5) The duration of hospital stay, average 7 days)
- 1) the change of hish sensitive troponin(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(2) On admission, hospital day #2, hospital day #4, hospital day #7 or discharge, 1 month/6month after discharge)
- 4) bleeding event(4) On admission, hospital day #2, hospital day #4, hospital day #7 or discharge, 1 month/3month/6month after discharge)
- 6) all-cause mortality(6) 6 months after hospitalization)
- 7) all-cause hospitalization & mortality(7) 6 months after hospitalization)