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

Phase 3

• Conditions: Cerebral Venous Thrombosis
• Interventions: Drug: Dabigatran etexilate; Drug: Warfarin

• Registration Number: NCT03217448
• Lead Sponsor: Capital Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-14
• Study Start: 2017-10-30
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-22
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dabigatran etexilate group	Dabigatran etexilate	Subjects in this group will take Dabigatran etexilate for 6 months after randomization
Warfarin group	Warfarin	Subjects in this group will take Warfarin for 6 months after randomization

Primary Outcome Measures

Name	Time	Method
The incidence of recanalized cerebral veins after 6 months	0-6 months after randomization	cerebral venous recanalisation rate after anticoagulation treatment for 6 months.

Secondary Outcome Measures

Name	Time	Method
Number of subjects with major bleeding events	0-6 months after randomization	Number of subjects with major bleeding events according to International Society on Thrombosis and Haemostasis criteria within 6 months.
Number of subjects with any bleeding events within 6 months	0-6 months after randomization
Number of subjects with venous thrombosis events	0-6 months after randomization	Number of subjects with recurrent cerebral venous and dural sinus thrombosis, deep venous thrombosis of any limb, pulmonary embolism or splanchnic vein thrombosis within 6 months.
The change of optic disc edema grade and lumbar puncture pressure after 6 months	0-6 months after randomization
Number of subjects with clinically relevant non-major bleeding events	0-6 months after randomization	Number of subjects with clinically relevant non-major bleeding events according to International Society on Thrombosis and Haemostasis criteria within 6 months.
Number of subjects with new intracranial haemorrhage or worsening of the previous intracranial haemorrhage	0-6 months after randomization

Trial Locations

Locations (1)

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, China