Comparison of Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran in Patients With Non-valvular Atrial Fibrillation (RIVAL-AF Study) -Multicenter Randomized Study-
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 16
- 主要终点
- median variation of inflammatory markers (including high sensitivity C reactive protein, pentraxin3, interleukin-6, and interleukin-18) between at baseline and 12 months later in each treatment group
研究概览
简要总结
The purpose of this study is to evaluate the antiinflammatory effects of rivaroxaban compared with dabigatran in patients with atrial fibrillation.
详细描述
Previous study showed that administration of rivaroxaban reduced expression of proinflammatory mediators in apolipoprotein E-deficient mice. However, it is unknown whether the anti-inflammatory markers are decreased in patients with atrial fibrillation receiving novel oral anticoagulants.
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
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-valvular atrial fibrillation
- •a CHADS2-VASc score of 1 or more
排除标准
- •contraindication for rivaroxaban or dabigatran
- •stroke or systemic embolism, acute coronary syndromes or peripheral artery disease within 6 months before enrollment
- •acute heart failure
- •severe chronic renal failure (creatinine clearance < 30mL/min.)
- •receiving dual antiplatelet therapy
- •patients with a body weight of 50kg or less
- •uncontrolled hypertension
- •active malignancy, collagen disease, or infectious disease
- •patients undergoing surgery within 6 months before enrollment
- •patients who are planned to undergoing catheter ablation for atrial fibrillation
- •patients who are not allowed to participate in the trial by judgement of the treating physician
研究组 & 干预措施
rivaroxaban
Patients are assigned to receive rivaroxaban 15mg once daily for 12 months according to a computer-generated randomization sequence at the central registration center. Patients with creatinine clearance 30-49 mL/min receive rivaroxaban 10mg once daily.
干预措施: Rivaroxaban (Drug)
dabigatran
Patients are assigned to receive dabigatran 150mg twice daily for 12 months according to a computer-generated randomization sequence at the central registration center. Patients at a high risk of bleeding receive dabigatran 110mg twice daily.
干预措施: Dabigatran (Drug)
结局指标
主要结局
median variation of inflammatory markers (including high sensitivity C reactive protein, pentraxin3, interleukin-6, and interleukin-18) between at baseline and 12 months later in each treatment group
时间窗: 12 months
次要结局
- change over time of above inflammatory markers during 12 months follow-up period (at baseline, 1 month, 3 months, 6 months, and 12 months later) in each treatment group(12 months)
研究者
Kiyoshi Hibi
Associate Professor, Division of Cardiology
Yokohama City University Medical Center