A clinical trial comparing efficacy and safety of dabigatran etexilate with warfarin in patients with cerebral venous and dural sinus thrombosis (RE-SPECT CVT)
- Conditions
- cerebral vein and dural sinus thrombosisMedDRA version: 19.1 Level: HLT Classification code 10008209 Term: Cerebrovascular venous and sinus thrombosis System Organ Class: 100000004852Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2015-004412-38-PT
- Lead Sponsor
- nilfarma - União Internacional de Lab. Farmacêuticos, Lda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 123
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to compare net clinical benefit of the treatment arms, as measured by the composite of venous thrombotic events (VTE) (recurring CVT, deep venous thrombosis (DVT) of any limb, pulmonary embolism (PE), or splanchnic vein thrombosis) + major bleeding according to ISTH criteria;Secondary Objective: Secondary objectives include a comparison of additional efficacy and safety parameters;<br> Primary end point(s): 1: Composite of the number of patients with major bleeding according to ISTH criteria and Venous Thrombotic Event (VTE) (recurring CVT; deep venous thrombosis (DVT) of any limb, pulmonary embolism (PE), splanchnic vein thrombosis) after up to 24 weeks<br> ;<br> Timepoint(s) of evaluation of this end point: 1: up to 24 weeks<br>
- Secondary Outcome Measures
Name Time Method