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: Completed
• Trial end date: 2018-06-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Dabigatran; Warfarin

Criteria

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