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

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ClinicalTrials.gov Identifier: NCT03217448
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Ji Xunming, 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.

Condition or disease Intervention/treatment Phase
Cerebral Venous Thrombosis Drug: Dabigatran etexilate Drug: Warfarin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Dabigatran Etexilate Comparing With Warfarin for the Anticoagulation Treatment of Cerebral Venous Thrombosis :a Pilot Study
Actual Study Start Date : October 30, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019


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.




Primary Outcome Measures :
  1. The incidence of recanalized cerebral veins after 6 months [ Time Frame: 0-6 months after randomization ]
    cerebral venous recanalisation rate after anticoagulation treatment for 6 months.


Secondary Outcome Measures :
  1. Number of subjects with venous thrombosis events [ Time Frame: 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.

  2. The change of optic disc edema grade and lumbar puncture pressure after 6 months [ Time Frame: 0-6 months after randomization ]
  3. Number of subjects with major bleeding events [ Time Frame: 0-6 months after randomization ]
    Number of subjects with major bleeding events according to International Society on Thrombosis and Haemostasis criteria within 6 months.

  4. Number of subjects with clinically relevant non-major bleeding events [ Time Frame: 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.

  5. Number of subjects with new intracranial haemorrhage or worsening of the previous intracranial haemorrhage [ Time Frame: 0-6 months after randomization ]
  6. Number of subjects with any bleeding events within 6 months [ Time Frame: 0-6 months after randomization ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217448


Contacts
Contact: Xunming Ji +86-83198952 jixunming@vip.163.com
Contact: Tingting Bian biantingting062350@163.com

Locations
China
Xuanwu Hospital Capital Medical University Recruiting
Beijing, China
Contact: Jiangang Duan    18611207077    13821682607@163.com   
Sponsors and Collaborators
Capital Medical University

Responsible Party: Ji Xunming, Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT03217448     History of Changes
Other Study ID Numbers: DE-CVT
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Embolism and Thrombosis
Thrombosis
Venous Thrombosis
Vascular Diseases
Cardiovascular Diseases
Warfarin
Dabigatran
Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action