Rivaroxaban Compared to Warfarin for Treatment of Cerebral Venous Thrombosis: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Change of sinus venous thrombosis severity scale (SVTSS)
研究概览
简要总结
Cerebral venous thrombosis (CVT) is an uncommon venous-type of stroke tends to affect younger patients with somewhat different risk factors and much better outcome compared to arterial strokes. Anti-coagulation is the standard of treatment for patients with (CVT) initially with heparins followed by other oral blood thinners for several months. In this study, the investigators are comparing warfarin with another well-known blood thinner, rivaroxaban, which has a fixed once-daily dose with no need for monitoring in terms of clinical outcomes and complications.
详细描述
Background:
Cerebral venous and/or dural sinus thrombosis (CVT) is an uncommon but increasingly recognized form of stroke accounts for up to 1% of all cerebral vascular accidents (CVAs), with an estimated incidence of 5 cases per million people per year, it usually affects young patients with a female to male ratio of 3:1.
The pathogenesis of CVT is still not entirely clear. Partly because of the highly variable venous anatomy and the shortage of animal studies. However, decreased venous blood flow drainage and cerebrospinal fluid (CSF) absorption may lead to elevation of intracranial pressure and/or cerebral parenchymal lesions or dysfunction that may contribute to the clinical features of CVT.
Diagnosis and management of (CVT) can be challenging given the diversity of causes and risk factors with a wide range of symptoms and signs. At least one identifiable risk factor was found in 85% of patients of the (ISCVT) study while multiple predisposing factors were found in 44%. The most common risk factors were oral contraceptives and inherited and acquired thrombophilia conditions.
the most common symptom is headache. It is found in 90% of patients with (CVT) usually associated with focal neurological symptoms or seizures. Isolated headaches account only for 15% of 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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 14 years or older and weighing more than 50 kg.
- •Recent diagnosis of symptomatic cerebral venous thrombosis confirmed by MRI modalities, CT venography, or conventional angiography.
排除标准
- •Any absolute contraindication to anticoagulation.
- •Impaired renal function (CrCl < 30 mL/min using Cockcroft-Gault equation).
- •Pregnancy or lactation at randomization.
- •mandatory other blood thinners use (e.g. Aspirin).
研究组 & 干预措施
Warfarin arm
Patients randomly assigned to (W) group will receive an adjusted dose of warfarin with targeted INR of 2.0 to 3.0.
干预措施: Warfarin (Drug)
Rivaroxaban arm
Patients randomly assigned to (R) group will receive 20mg rivaroxaban daily if CrCl>50 mL/min using Cockcroft-Gault equation or 15mg rivaroxaban daily if CrCl 30-50 mL/min.
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
Change of sinus venous thrombosis severity scale (SVTSS)
时间窗: SVTSS score will be evaluated at the point of admission, and each month after for 6 months later
it was designed by Einhaupl 1991 who performed with his colleagues the first clinical trial of heparin in (CVT) Patients score is given to each of the 4 categories as follows: 1. Headache: (1: slight, 2: moderate, 3: severe) 2. Focal signs: (1: transient or minimum hypesthesia, 2: transient or slight paresis, 3: mild paresis, 4: moderate paresis, 5: severe paresis or plegia) 3. seizures: (3: seizures (no series or status), 4: series or status) 4. consciousness: (5: confused or psychotic, 6: somnolent, 7: stupor, 8: coma, 9: dead). Please refer to appendix 1 for more details
次要结局
- Change of Barthel index(Barthel index will be evaluated at the point of admission, and each month after for 6 months later)