NCT03217448Unknown3 期
The Efficacy and Safety of Dabigatran Etexilate Comparing With Warfarin for the Anticoagulation Treatment of Cerebral Venous Thrombosis :a Pilot Study
Capital Medical University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年10月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The incidence of recanalized cerebral veins after 6 months
研究概览
简要总结
This is a single-center, prospective, randomized (1:1), open-label study with two parallel groups. This study is planned to investigate the efficacy and safety of dabigatran etexilate comparing with warfarin for the treatment of cerebral venous thrombosis.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Cerebral Venous thrombosis (CVT), with or without intracranial haemorrhage.
- •Patients in the acute or sub-acute phase of CVT.
- •Completion of anticoagulation therapy for 5-15 days which has been administered until randomization; anticoagulation must include full-dose low molecular weight heparin or unfractionated heparin.
- •Eligibility for treatment with an oral anticoagulant.
- •Written informed consent.
排除标准
- •Cerebral Venous thrombosis (CVT) associated with central nervous system infection or due to head trauma.
- •Thrombosed venous sinuses showed completely recanalized by MRV before randomisation.
- •Planned endovascular treatment for CVT or surgical treatment for other diseases.
- •Conditions associated with increased risk of bleeding.
- •History of symptomatic non-traumatic intracranial haemorrhage with increased risk of recurrence according to investigator's judgment.
- •Treatment with an antithrombotic regimen for an indication other than CVT and requiring continuation of that treatment for the original diagnosis.
- •Severe renal impairment(CrCL<30mL/min).
- •Active liver disease (ALT≥ twice the upper limit of normal).
- •Preganancy, nursing or planning to become pregnant during the trial.
研究组 & 干预措施
Dabigatran etexilate group
Experimental
Subjects in this group will take Dabigatran etexilate for 6 months after randomization
干预措施: Dabigatran etexilate (Drug)
Warfarin group
Active Comparator
Subjects in this group will take Warfarin for 6 months after randomization
干预措施: Warfarin (Drug)
结局指标
主要结局
The incidence of recanalized cerebral veins after 6 months
时间窗: 0-6 months after randomization
cerebral venous recanalisation rate after anticoagulation treatment for 6 months.
次要结局
- Number of subjects with major bleeding events(0-6 months after randomization)
- Number of subjects with any bleeding events within 6 months(0-6 months after randomization)
- Number of subjects with venous thrombosis events(0-6 months after randomization)
- The change of optic disc edema grade and lumbar puncture pressure after 6 months(0-6 months after randomization)
- Number of subjects with clinically relevant non-major bleeding events(0-6 months after randomization)
- Number of subjects with new intracranial haemorrhage or worsening of the previous intracranial haemorrhage(0-6 months after randomization)
研究者
Ji Xunming
Professor
Capital Medical University
研究点 (1)
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