The Efficacy and Safety of Dabigatran Etexilate for the Treatment of Cerebral Venous Thrombosis

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-center, prospective, randomized (1:1), open-label study with two parallel groups. This study is planned to investigate the efficacy and safety of dabigatran etexilate comparing with warfarin for the treatment of cerebral venous thrombosis.

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

Details

• Lead Sponsor: Capital Medical University
• Treatments: Dabigatran; Warfarin

Criteria

Inclusion Criteria:

• Confirmed diagnosis of Cerebral Venous thrombosis (CVT), with or without intracranial haemorrhage.

• Patients in the acute or sub-acute phase of CVT.

• Completion of anticoagulation therapy for 5-15 days which has been administered until randomization; anticoagulation must include full-dose low molecular weight heparin or unfractionated heparin.

• Eligibility for treatment with an oral anticoagulant.

• Written informed consent.

Exclusion Criteria:

• Cerebral Venous thrombosis (CVT) associated with central nervous system infection or due to head trauma.

• Thrombosed venous sinuses showed completely recanalized by MRV before randomisation.

• Planned endovascular treatment for CVT or surgical treatment for other diseases.

• Conditions associated with increased risk of bleeding.

• History of symptomatic non-traumatic intracranial haemorrhage with increased risk of recurrence according to investigator's judgment.

• Treatment with an antithrombotic regimen for an indication other than CVT and requiring continuation of that treatment for the original diagnosis.

• Severe renal impairment(CrCL<30mL/min).

• Active liver disease (ALT≥ twice the upper limit of normal).

• Preganancy, nursing or planning to become pregnant during the trial.