Health Condition 1: null- Cerebral Venous and dural sinus Thrombosis
Conditions
Interventions
Intervention1: Pradaxa;
Dabigatran
Etexilate: 1 x 150mg capsule b.i.d. (total daily dose 300mg). Treatment duration is 6 months.
Control Intervention1: Active
Comparator;
Warfarin: Oral Tablets, 1mg
Sponsors
Boehringer Ingelheim India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent in accordance with International Conference on Harmonization Good Clinical Practice (GCP) guidelines and local legislation and/or regulations. 2. Male or female patients. WOCBP1 must be ready and able to use highly effective methods of birth control per International Conference on Harmonization M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. 3. Age >= 18 years and 4. Confirmed diagnosis of CVT2, with or without ICH. 5. Patient has achieved clinical stability after having received standard acute CVT treatment as required, including anticoagulation therapy for 5-15 days which has been administered until randomisation; anticoagulation must include full-dose LMWH or UFH and may be followed by oral VKA treatment. 6. Eligible for treatment with an oral anticoagulant for their CVT, based on Investigator judgment. Based on risk assessment and clinical condition, patient should be a candidate for at least 24 weeks of oral anticoagulation. 7. Availability of the imaging that was used to diagnose the CVT for the purpose of external review.
Exclusion criteria
Exclusion criteria: 1. Inability to swallow medications. 2. CVT associated with central nervous system infection. 3. CVT due to head trauma. 4. Planned for surgical treatment for CVT (e.g. decompressive surgery, ear-nose-throat surgery). 5. Conditions associated with increased risk of bleeding. 6. Life-threatening or major bleeding other than ICH due to the index CVT, during the 6 months prior to randomisation or while on anticoagulants during the acute phase of CVT. 7. History of symptomatic non-traumatic ICH with risk of recurrence according to Investigator judgment (including haemorrhagic stroke within 6 months prior to screening, but other than ICH during the acute phase of CVT). 8. Severe renal impairment defined as CrCl (calculated by Cockcroft-Gault equation) 9. Patients who require taking any of the drugs listed as restricted in Section 4.2.2.1 while on active treatment with study drug. 10. Patients receiving treatment with warfarin, dabigatran etexilate or other antithrombotic regimen (i.e. anticoagulants or anti-platelet medication) for an indication other than CVT and requiring continuation of that treatment for the original diagnosis without change in the regimen. 11. Active liver disease. 12. Any current or recent malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for this trial is the composite of the number of patients with major bleeding according to ISTH criteria and VTE (recurring CVT; DVT of any limb, PE, splanchnic vein thrombosis) after up to 24 weeks. All components are adjudicated in a blinded manner by an AC.Timepoint: The primary endpoint for this trial is the composite of the number of patients with major bleeding according to ISTH criteria and VTE (recurring CVT; DVT of any limb, PE, splanchnic vein thrombosis) after up to 24 weeks. All components are adjudicated in a blinded manner by an AC. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of patients with recurring CVT; DVT of any limb, PE or splanchnic vein thrombosis, 2. Cerebral venous recanalisation as measured by the change in number of occluded cerebral veins and sinuses, 3. Number of patients with major bleeding according to ISTH criteria after up to 24 weeksTimepoint: After upto 24 weeks. | — |
Countries
Canada, France, Germany, India, Italy, Netherlands, Poland, Portugal, Russian Federation, Spain
Contacts
Public ContactDr Partha Gokhale
Boehringer Ingelheim Pvt Ltd
Outcome results
None listed