A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT)
Status and phase
Completed
Phase 3
Conditions
Thromboembolism
Treatments
Drug: Dabigatran etexilate
Drug: Warfarin
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
120 patients
Sex
All
Ages
18 to 78 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- 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 weight heparin or unfractionated heparin
- Eligibility for treatment with an oral anticoagulant
- Further inclusion criteria apply
Exclusion criteria
- Cerebral Venous or dural sinus thrombosis (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 for an indication other than CVT and requiring continuation of that treatment for the original diagnosis without change in the regimen
- Severe renal impairment
- Active liver disease
- Pregnancy, nursing or planning to become pregnant while in the trial
- Further exclusion criteria apply
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
120 participants in 2 patient groups
Dabigatran etexilate
Experimental group
Treatment:
Drug: Dabigatran etexilate
Warfarin
Active Comparator group
Treatment:
Drug: Warfarin
Trial contacts and locations
36
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Data sourced from clinicaltrials.gov
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