NL-OMON45785已完成3 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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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
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 judgement;- 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
研究者
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