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

Cerebral Venous Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03217448
• Other study ID #: DE-CVT
• Status: Recruiting
• Phase: Phase 3
• First received: July 12, 2017
• Last updated: November 21, 2017
• Start date: October 30, 2017
• Est. completion date: January 2019

Study information

• Verified date: November 2017
• Source: Capital Medical University
• Contact: Xunming Ji
• Phone: +86-83198952
• Email: jixunming[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Venous Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Dabigatran etexilate
Subjects should take Dabigatran etexilate 150mg twice a day for 6 months after randomization.
• Warfarin
Subjects should take Warfarin for 6 months after randomization and the dose will be changed according to investigator's judgment.

Locations

Country	Name	City	State
China	Xuanwu Hospital Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The change of optic disc edema grade and lumbar puncture pressure after 6 months		0-6 months after randomization
Secondary	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
Secondary	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
Secondary	Number of subjects with new intracranial haemorrhage or worsening of the previous intracranial haemorrhage		0-6 months after randomization
Secondary	Number of subjects with any bleeding events within 6 months		0-6 months after randomization