RE-SPECT CVT: a randomised, open-label, exploratory trial with blinded endpoint adjudication (PROBE), comparing efficacy and safety of oral dabigatran etexilate versus oralwarfarin in patients with cerebral venous and dural sinus thrombosis over a 24-week period - RE-SPECT CVT

Boehringer Ingelheim India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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 < 79 years at Visit 1.
•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

•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
•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)
•<30mL/min at screening, or if the Investigator expects CrCl is likely to drop below 30mL/min during the course of the study.
•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.

发起方

Boehringer Ingelheim India Pvt Ltd