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

The Efficacy and Safety of Dabigatran Etexilate Comparing With Warfarin for the Anticoagulation Treatment of Cerebral Venous Thrombosis :a Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Cerebral Venous Thrombosis
• Intervention / Treatment: Drug: Dabigatran etexilate; Drug: Warfarin

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Xuanwu Hospital Capital Medical University
    • Contact: Jiangang Duan; Phone Number: 18611207077; Email: 13821682607@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dabigatran etexilate group; Subjects in this group will take Dabigatran etexilate for 6 months after randomization	Drug: Dabigatran etexilate; Subjects should take Dabigatran etexilate 150mg twice a day for 6 months after randomization.
Active Comparator: Warfarin group; Subjects in this group will take Warfarin for 6 months after randomization	Drug: Warfarin; Subjects should take Warfarin for 6 months after randomization and the dose will be changed according to investigator's judgment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of recanalized cerebral veins after 6 months	cerebral venous recanalisation rate after anticoagulation treatment for 6 months.	0-6 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with venous thrombosis events	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.	0-6 months after randomization
The change of optic disc edema grade and lumbar puncture pressure after 6 months		0-6 months after randomization
Number of subjects with major bleeding events	Number of subjects with major bleeding events according to International Society on Thrombosis and Haemostasis criteria within 6 months.	0-6 months after randomization
Number of subjects with clinically relevant non-major bleeding events	Number of subjects with clinically relevant non-major bleeding events according to International Society on Thrombosis and Haemostasis criteria within 6 months.	0-6 months after randomization
Number of subjects with new intracranial haemorrhage or worsening of the previous intracranial haemorrhage		0-6 months after randomization
Number of subjects with any bleeding events within 6 months		0-6 months after randomization

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): November 22, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Dabigatran; Warfarin
• Other Study ID Numbers: DE-CVT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No