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

Primary Purpose

Cerebral Venous Thrombosis

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Dabigatran etexilate
Warfarin
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Venous Thrombosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Xuanwu Hospital Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dabigatran etexilate group

Warfarin group

Arm Description

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

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

Outcomes

Primary Outcome Measures

The incidence of recanalized cerebral veins after 6 months
cerebral venous recanalisation rate after anticoagulation treatment for 6 months.

Secondary Outcome Measures

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.
The change of optic disc edema grade and lumbar puncture pressure after 6 months
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.
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.
Number of subjects with new intracranial haemorrhage or worsening of the previous intracranial haemorrhage
Number of subjects with any bleeding events within 6 months

Full Information

First Posted
July 12, 2017
Last Updated
November 21, 2017
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03217448
Brief Title
The Efficacy and Safety of Dabigatran Etexilate for the Treatment of Cerebral Venous Thrombosis
Official Title
The Efficacy and Safety of Dabigatran Etexilate Comparing With Warfarin for the Anticoagulation Treatment of Cerebral Venous Thrombosis :a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Venous Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dabigatran etexilate group
Arm Type
Experimental
Arm Description
Subjects in this group will take Dabigatran etexilate for 6 months after randomization
Arm Title
Warfarin group
Arm Type
Active Comparator
Arm Description
Subjects in this group will take Warfarin for 6 months after randomization
Intervention Type
Drug
Intervention Name(s)
Dabigatran etexilate
Intervention Description
Subjects should take Dabigatran etexilate 150mg twice a day for 6 months after randomization.
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
Subjects should take Warfarin for 6 months after randomization and the dose will be changed according to investigator's judgment.
Primary Outcome Measure Information:
Title
The incidence of recanalized cerebral veins after 6 months
Description
cerebral venous recanalisation rate after anticoagulation treatment for 6 months.
Time Frame
0-6 months after randomization
Secondary Outcome Measure Information:
Title
Number of subjects with venous thrombosis events
Description
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.
Time Frame
0-6 months after randomization
Title
The change of optic disc edema grade and lumbar puncture pressure after 6 months
Time Frame
0-6 months after randomization
Title
Number of subjects with major bleeding events
Description
Number of subjects with major bleeding events according to International Society on Thrombosis and Haemostasis criteria within 6 months.
Time Frame
0-6 months after randomization
Title
Number of subjects with clinically relevant non-major bleeding events
Description
Number of subjects with clinically relevant non-major bleeding events according to International Society on Thrombosis and Haemostasis criteria within 6 months.
Time Frame
0-6 months after randomization
Title
Number of subjects with new intracranial haemorrhage or worsening of the previous intracranial haemorrhage
Time Frame
0-6 months after randomization
Title
Number of subjects with any bleeding events within 6 months
Time Frame
0-6 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xunming Ji
Phone
+86-83198952
Email
jixunming@vip.163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tingting Bian
Email
biantingting062350@163.com
Facility Information:
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiangang Duan
Phone
18611207077
Email
13821682607@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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