Cerebral Venous ThrombosisPhase 3NCT03217448
The Efficacy and Safety of Dabigatran Etexilate for the Treatment of Cerebral Venous Thrombosis
A Phase 3 study testing Dabigatran etexilate and Warfarin in people with Cerebral Venous Thrombosis, run by Capital Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Venous Thrombosis
- What is being tested?
- Dabigatran etexilate and Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2017to Jan 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Tingting Bian contact
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing
Jiangang Duan, 18611207077, 13821682607@163.com
About this study
Official title: The Efficacy and Safety of Dabigatran Etexilate Comparing With Warfarin for the Anticoagulation Treatment of Cerebral Venous Thrombosis :a Pilot Study
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.
- Conditions
- Cerebral Venous Thrombosis
- Being tested
- Dabigatran etexilate, Warfarin
- Medical subject headings
- Intracranial Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran etexilateDrug
Subjects should take Dabigatran etexilate 150mg twice a day for 6 months after randomization.
WarfarinDrug
Subjects should take Warfarin for 6 months after randomization and the dose will be changed according to investigator's judgment.
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran etexilate group | Experimental | Subjects in this group will take Dabigatran etexilate for 6 months after randomization Receives: Drug: Dabigatran etexilate |
| Warfarin group | Active comparator | Subjects in this group will take Warfarin for 6 months after randomization Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of recanalized cerebral veins after 6 months
cerebral venous recanalisation rate after anticoagulation treatment for 6 months.
Measured: 0-6 months after randomization
Secondary outcomes (6)
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.
Measured: 0-6 months after randomization
The change of optic disc edema grade and lumbar puncture pressure after 6 months
Measured: 0-6 months after randomization
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.
Measured: 0-6 months after randomization
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.
Measured: 0-6 months after randomization
Number of subjects with new intracranial haemorrhage or worsening of the previous intracranial haemorrhage
Measured: 0-6 months after randomization
Number of subjects with any bleeding events within 6 months
Measured: 0-6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start30 Oct 2017
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217448
- Sponsor's protocol ID
- DE-CVT
- Status last verified
- Nov 2017
- First submitted
- 12 Jul 2017
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Dabigatran Etexilate Comparing With Warfarin for the Anticoagulation Treatment of Cerebral Venous Thrombosis :a Pilot Study
- ClinicalTrials.gov ID
- NCT03217448
- Acronym / sponsor ID
- DE-CVT
- Conditions
- Cerebral Venous Thrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dabigatran etexilate group | Experimental | Drug: Dabigatran etexilateSubjects in this group will take Dabigatran etexilate for 6 months after randomization |
| Warfarin group | Active comparator | Drug: WarfarinSubjects in this group will take Warfarin for 6 months after randomization |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dabigatran etexilateSubjects should take Dabigatran etexilate 150mg twice a day for 6 months after randomization. | Drug | Dabigatran etexilate group |
| WarfarinSubjects should take Warfarin for 6 months after randomization and the dose will be changed according to investigator's judgment. | Drug | Warfarin group |
Primary outcome
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.
6 secondary outcomes
Number of subjects with venous thrombosis events
Time frame: 0-6 months after randomization
The change of optic disc edema grade and lumbar puncture pressure after 6 months
Time frame: 0-6 months after randomization
Number of subjects with major bleeding events
Time frame: 0-6 months after randomization
Number of subjects with clinically relevant non-major bleeding events
Time frame: 0-6 months after randomization
Number of subjects with new intracranial haemorrhage or worsening of the previous intracranial haemorrhage
Time frame: 0-6 months after randomization
Number of subjects with any bleeding events within 6 months
Time frame: 0-6 months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tingting Bian contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dabigatran etexilate and Warfarin in people with Cerebral Venous Thrombosis, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xunming Ji (+86-83198952, jixunming@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of recanalized cerebral veins after 6 months (time frame: 0-6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.