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

NCT ID: NCT03217448

Last Updated: 2017-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-30

Study Completion Date

2019-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Venous Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Dabigatran etexilate group

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

Group Type EXPERIMENTAL

Dabigatran etexilate

Intervention Type DRUG

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

Warfarin group

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

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

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

Interventions

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Dabigatran etexilate

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

Intervention Type DRUG

Warfarin

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ji Xunming

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xuanwu Hospital Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xunming Ji

Role: CONTACT

Phone: +86-83198952

Email: [email protected]

Tingting Bian

Role: CONTACT

Email: [email protected]

Facility Contacts

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Jiangang Duan

Role: primary

Other Identifiers

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DE-CVT

Identifier Type: -

Identifier Source: org_study_id