NCT03217448

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

October 30, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

November 22, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

July 12, 2017

Last Update Submit

November 21, 2017

Conditions

Cerebral Venous Thrombosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Number of subjects with venous thrombosis events

    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

    0-6 months after randomization

  • Number of subjects with clinically relevant non-major bleeding events

    0-6 months after randomization

  • Number of subjects with new intracranial haemorrhage or worsening of the previous intracranial haemorrhage

    0-6 months after randomization

  • +1 more secondary outcomes

Study Arms (2)

Dabigatran etexilate group

EXPERIMENTAL

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

Drug: Dabigatran etexilate

Warfarin group

ACTIVE COMPARATOR

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

Drug: Warfarin

Interventions

Dabigatran etexilateDRUG

Subjects should take Dabigatran etexilate 150mg twice a day for 6 months after randomization.

Dabigatran etexilate group
WarfarinDRUG

Subjects should take Warfarin for 6 months after randomization and the dose will be changed according to investigator's judgment.

Warfarin group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Intracranial Thrombosis

Interventions

DabigatranWarfarin

Condition Hierarchy (Ancestors)

Intracranial Embolism and ThrombosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesThromboembolismEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring4-HydroxycoumarinsCoumarinsBenzopyransPyrans

Central Study Contacts

Xunming Ji

CONTACT

+86-83198952jixunming@vip.163.com

Tingting Bian

CONTACT

biantingting062350@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 14, 2017

Study Start

October 30, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

November 22, 2017

Record last verified: 2017-11

Locations

CN(1)