EUCTR2015-004412-38-PT进行中（未招募）1 期
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 - RE-SPECT CVT
nilfarma - União Internacional de Lab. Farmacêuticos, Lda0 个研究点目标入组 123 人开始时间: 2016年8月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 123
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Written informed consent in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and local legislation and/or regulations
- •- Confirmed diagnosis of Cerebral Venous or dural sinus thrombosis (CVT), with or without intracranial haemorrhage
- •- Completion of anticoagulation therapy for 5-15 days which has been administered until randomisation; anticoagulation must include full-dose low molecular weigth heparin or unfractionated heparin
- •- Eligibility for treatment with an oral anticoagulant
- •Further inclusion criteria apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 165
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •- CVT associated with central nervous system infection or due to head trauma
- •- Planned surgical treatment for CVT
- •- Conditions associated with increased risk of bleeding
- •- History of symptomatic non-traumatic intracranial haemorrhage with risk of recurrence according to Investigator judgment
- •- Treatment with an antithrombotic regimen before CVT diagnosis and requiring continuation of that treatment for the original diagnosis without change in the regimen
- •- Severe renal impairment
- •- Active liver disease
- •- Preganancy, nursing or planning to become pregnant while in the trial
- •Further exclusion criteria apply
研究者
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