A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT)

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 orwithout intracranial haemorrhage

• Completion of anticoagulation therapy for 5-15 days which has been administered untilrandomisation; anticoagulation must include full-dose low molecular weight heparin orunfractionated 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 systeminfection 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 recurrenceaccording to Investigator judgment

• Treatment with an antithrombotic regimen for an indication other than CVT andrequiring continuation of that treatment for the original diagnosis without change inthe regimen

• Severe renal impairment

• Active liver disease

• Pregnancy, nursing or planning to become pregnant while in the trial

• Further exclusion criteria apply