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

Capital Medical University

Status and phase: Unknown; Phase 3

Conditions: Cerebral Venous Thrombosis

Treatments: Drug: Dabigatran etexilate; Drug: Warfarin

Study type: Interventional

Funder types: Other

Identifiers

NCT03217448

DE-CVT

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Dabigatran etexilate group

Experimental group

Description:

Subjects in this group will take Dabigatran etexilate for 6 months after randomization

Treatment:

Drug: Dabigatran etexilate

Warfarin group

Active Comparator group

Description:

Subjects in this group will take Warfarin for 6 months after randomization

Treatment:

Drug: Warfarin