Anticoagulation With Rivaroxaban in Post Cardioversion Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Thrombosis
研究概览
简要总结
The purpose of this study is to determine that a new drug called "Rivaroxaban®" is effective in preventing patients from forming clots after their heart rhythm has been reset by the cardiologist with an electrical device.
详细描述
Patient who are electrically cardioverted require 1 month of anticoagulation (blood thinner). Rivaroxaban a Xa-inhibitor has been shown to be non-inferior to Warfarin (Vit K antagonist) the current standard of care in many treatment areas. Rivaroxaban will be compared to Warfarin historical control group studying the safety and efficacy in electrically cardioverted patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with non-valvular atrial fibrillation requiring electrical cardioversion o Atrial fibrillation of unknown duration
排除标准
- •Patients requiring extended anticoagulation after cardioversion due to concomitant risk factors as defined by CHADS2 score ≥ 1
- •Significant renal dysfunction (CrCl <15mL/min)
- •Significant hepatic dysfunction (Childs-Pugh Class B or C)
- •History of coagulopathy
- •Active bleeding
- •Hypersensitivity to Rivaroxaban
- •Concomitant use of anticoagulants
- •Concomitant use of potent CYP3A4/P-gp inhibitors or inducers
- •Interventions requiring interruption of therapy
- •Pregnancy
- •Age <18 y/o
- •History of GI Bleed
研究组 & 干预措施
Rivaroxaban
Anticoagulation with Rivaroxaban 20 mg daily with dinner for 30 days
干预措施: Rivaroxaban (Drug)
Warfarin and Enoxaparin
Warfarin: 1-10 mg per Nomogram Enoxaparin weight based 1 mg/kg Q12 or 1.5 mg/kg/day Historic control
干预措施: Warfarin and Enoxaparin (Drug)
结局指标
主要结局
Thrombosis
时间窗: 30 days
Number of cerebrovascular accidents, thrombus and embolism
次要结局
- Mortality(30 days)
- Hospitalizations(30 days)
- Bleeding(30 days)
研究者
Pete Antonopoulos
Clinical Pharmacist- Principal Investigator
Cook County Health