Comparing Treatment Outcomes in CVT Patients Who Treated With Warfarin and Rivaroxaban in Isfahan, Iran
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale
研究概览
简要总结
With regard to Cerebral Venous Thrombosis (CVT) importance as a life threatening disease, specific care is necessary, Known anti-coagulants have limitations.Vitamin K antagonists such as Warfarin, require laboratory monitoring and exact administration starting and maintenance dose. although Rivaroxaban(selective and direct Xa factor antagonist ) has no monitoring and no drug interaction. This study aim to focus on efficacy of Warfarin versus Rivaroxaban.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both gender
- •Age 18 years and higher
- •proven CVT on neuro imaging ( MRI-MRV)
排除标准
- •Patients suffering from renal failure(GFR<30) Patients
- •Patients with contraindications for oral anticoagulation
- •Patient who having pregnancy
- •Uncooperative patient for completing the course of treatment
研究组 & 干预措施
Rivoroxaban
Patients would be administered Enoxaparine (60 mg/SC/BID)in first day, after dicontinuing Enoxaparin in second day, Rivoroxaban 20 mg per day will use. .it would be given once a day.The total duration of Rivoroxaban would be 3 months.
干预措施: Rivaroxaban (Drug)
warfarin
Patients would be administered Warfarin with overlap of Enoxaparine utill INR adjust to 2-3 then enoxaparine will disconstinue.it would be given once a day.The total duration of Warfarin would be 3 months
干预措施: Warfarin (Drug)
结局指标
主要结局
Modified Rankin Scale
时间窗: 3 months
based on disability grade(0-6). 0 indicate patients have no disability and the worst score is 6.
次要结局
- hemorrhagic rate(3 months)
- Stroke(3 months)
研究者
Mohammad Saadatnia
Professor Mohammad Saadatnia
Isfahan University of Medical Sciences