RE-SPECT CVT: a Randomised, Open-label, Exploratory Trial With Blinded Endpoint Adjudication (PROBE), Comparing Efficacy and Safety of Oral Dabigatran Etexilate Versus Oral Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis Over a 24-week Period
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 36
- 主要终点
- Percentage of Participants With Composite of Venous Thrombotic Event (VTE) or Major Bleeding Event (MBE) According to International Society on Thrombosis and Haemostasis (ISTH) Criteria in Full Observation Period.
研究概览
简要总结
This is a multi-center, prospective, international, randomized (1:1), open-label study with two parallel groups. This phase III study is planned to investigate the efficacy and safety of dabigatran etexilate versus dose-adjusted warfarin on a net clinical benefit endpoint of major bleeding (ISTH criteria) and new venous thrombotic event (VTE) (primary endpoint) with blinded endpoint adjudication.
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 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dabigatran etexilate
干预措施: Dabigatran etexilate (Drug)
Warfarin
干预措施: Warfarin (Drug)
结局指标
主要结局
Percentage of Participants With Composite of Venous Thrombotic Event (VTE) or Major Bleeding Event (MBE) According to International Society on Thrombosis and Haemostasis (ISTH) Criteria in Full Observation Period.
时间窗: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.
Composite of the percentage of participants with MBE according to ISTH criteria and VTE (recurring cerebral venous thrombosis (CVT); deep venous thrombosis (DVT) of any limb, pulmonary embolism (PE), splanchnic vein thrombosis) in full observation period. All components were adjudicated in a blinded manner. Major bleeds were defined according to the ISTH definition of a major bleed, as follows: * Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or * Bleeding associated with a reduction in haemoglobin of at least 2 grams/deciLitre (1.24 millimole/Litre) within 24 h, or leading to transfusion of 2 or more units of blood or packed cells and/or * Fatal bleed
次要结局
- Percentage of Participants With Clinically Relevant Non-major Bleeding Events in Full Observation Period.(From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.)
- Percentage of Participants With Major Bleeding According to ISTH Criteria or CRNMBEs After up to 24 Weeks(From first administration of trial medication until end of treatment visit, up to 24 weeks.)
- Composite Endpoint of Percentage of Participants With New Intracranial Haemorrhage or Worsening of the Haemorrhagic Component of a Previous Lesion After up to 24 Weeks(From first administration of trial medication until end of treatment visit, up to 24 weeks.)
- Percentage of Participants With Recurring Cerebral Venous and Dural Sinus Thrombosis; DVT of Any Limb, PE or Splanchnic Vein Thrombosis in Full Observation Period(From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.)
- Cerebral Venous Recanalisation as Measured by the Change in Number of Occluded Cerebral Veins and Sinuses at Week 24(Baseline and week 24)
- Percentage of Participants With Major Bleeding According to ISTH Criteria in Full Observation Period(From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.)
- Percentage of Participants With Any Bleeding Event After up to 24 Weeks(From first administration of trial medication until end of treatment visit, up to 24 weeks.)