Cerebral Venous ThrombosisNCT06947707
Safety and Efficacy of Edoxaban and Rivaroxaban to Cerebral Venous Thrombosis in Chinese Patients
An observational study of Cerebral Venous Thrombosis and Anticoagulants and Thrombotic Disorders, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The goal of this observational study is to learn the safety and efficacy of edoxaban and rivaroxaban in Chinese population with the age range from 18 to 80 years who take edoxaban or rivaroxaban to treat their cerebral venous thrombosis (CVT). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Venous Thrombosis, Anticoagulants and Thrombotic Disorders, Anticoagulation Treatment
- How many people
- 1,486 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All patients with suspected CVT visited Xuanwu Hospital, Capital Medical University are evaluated from clinical symptoms, laboratory tests and neuroimaging findings. Eligible patients are screened according to the inclusion and exclusion criteria, and patients treated with edoxaban enter into "Edoxaban" group and with rivaroxaban into "Rivaroxaban" group.
Who may be able to join
- Patient aged from 18 to 80 years and no gender preference;
- Diagnosis of CVT as confirmed on MRBTI/MRV or CT/CTV or DSA;
- Acute or subacute CVT from onset to door within 4 weeks;
- The treating clinician irrelevant to the study is of the opinion that the patient is appropriate for edoxaban or rivaroxaban;
- Patient or legally authorized representative is able to give written informed consent.
Who cannot join
- Patient refuse to take edoxaban or rivaroxaban to treat CVT;
- Pregnancy or breastfeeding women at the time of enrollment, or women who plan to get pregnant during study;
- Patient is anticipated to require invasive procedure (e.g. thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation;
- CVT secondary to central nervous system infection or severe head trauma;
- It is in the proliferative stage of malignant tumors currently or within 6 months of diagnosis;
- Bleeding diathesis or other contraindication to anticoagulation;
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- Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use;
- Concomitant use of strong CYP3A4 or P-gp inhibitors;
- Impaired renal function (CrCl<30 mL/min using Cockcroft-Gault equation) or investigator anticipate the CrCl lower than 30 mL/min during study;
- Impaired liver function (ALT or AST exceeds twice the normal upper limit) or diagnosed as acute hepatitis currently;
- Patient is unable to swallow due to depressed level of consciousness or other reasons;
- Patient has a severe or fatal comorbid illness with life expectancy less than 6 months;
- Patient with severe hypertension (SBP≥180mmHg and/or DBP≥110mmHg);
- Patient is known to be allergic to edoxaban or rivaroxaban.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Da Zhou, +86-10-83199280, popdoctor@foxmail.com
Guangyu Han
About this study
Official title: Safety and Efficacy of Edoxaban and Rivaroxaban to Cerebral Venous Thrombosis in Chinese Patients: A Prospective Cohort Study
The goal of this observational study is to learn the safety and efficacy of edoxaban and rivaroxaban in Chinese population with the age range from 18 to 80 years who take edoxaban or rivaroxaban to treat their cerebral venous thrombosis (CVT). The main question it aims to answer are:
- Do cerebral veins or venous sinuses recanalize during the treatment period of edoxaban and rivaroxaban?
- Do the bleeding events occur during the treatment period of edoxaban and rivaroxaban?
Read more
The main tasks participants will be asked to do:
- Participants will comply fully with the prescribed regimen and take the edoxaban or rivaroxaban as directed at the specified dosage.
- Participants will return to hospital for scheduled follow-up assessments at months 3, 6, 9, and 12 post-enrollment to undergo face-to-face visits with investigators.
- Conditions
- Cerebral Venous Thrombosis, Anticoagulants and Thrombotic Disorders, Anticoagulation Treatment, Anticoagulant Therapy, Anticoagulant Drugs, NOACs
- Medical subject headings
- Intracranial Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| edoxaban | Not described | |
| Rivaroxaban | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recanalization of cerebral veins or venous sinuses
Measured: 1 year
major bleeding events
- Symptomatic intracranial bleeding A new symptomatic intracranial hemorrhage OR worsening existing intracranial hemorrhage with a ≥33% change in hematoma volume, AND either an NIHSS score increase of 4 or more points, or a change in level of consciousness as per NIHSS item 1a, AND the clinical change is thought to be attributable to the hemorrhage.
- Other major bleeding Bleeding in a critical area or organ, including intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a drop in hemoglobin by 20 g/L or more, leading to transfusion of 2 or more units of whole blood or red cells.
Measured: 1 year
Secondary outcomes (2)
Venous thrombosis or recurrence of CVT
Venous thrombosis (including deep vein thrombosis or pulmonary embolism or visceral vein thrombosis) or recurrence of CVT (including new-onset CVT or progression of previous CVT)
Measured: 1 year
Death or clinically relevant non-major bleeding events
Death related to venous thrombosis events or from other causes. A clinically relevant non-major bleeding event is an acute or subacute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of: (a) a hospital admission for bleeding, or (b) a physician guided medical or surgical treatment for bleeding, or (c) a change in antithrombotic therapy (including interruption or discontinuation of study drug).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start10 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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 Xuanwu Hospital, BeijingThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng Ran, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947707
- Sponsor's protocol ID
- RMeng2
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Edoxaban and Rivaroxaban to Cerebral Venous Thrombosis in Chinese Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06947707
- Acronym / sponsor ID
- RMeng2
- Conditions
- Cerebral Venous Thrombosis, Anticoagulants and Thrombotic Disorders, Anticoagulation Treatment, Anticoagulant Therapy, Anticoagulant Drugs, NOACs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,486 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Apr 2025 (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.
The goal of this observational study is to learn the safety and efficacy of edoxaban and rivaroxaban in Chinese population with the age range from 18 to 80 years who take edoxaban or rivaroxaban to treat their cerebral venous thrombosis (CVT). The main question it aims to answer are:
- Do cerebral veins or venous sinuses recanalize during the treatment period of edoxaban and rivaroxaban?
- Do the bleeding events occur during the treatment period of edoxaban and rivaroxaban?
The main tasks participants will be asked to do:
- Participants will comply fully with the prescribed regimen and take the edoxaban or rivaroxaban as directed at the specified dosage.
- Participants will return to hospital for scheduled follow-up assessments at months 3, 6, 9, and 12 post-enrollment to undergo face-to-face visits with investigators.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| edoxaban | – | – |
| Rivaroxaban | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with suspected CVT visited Xuanwu Hospital, Capital Medical University are evaluated from clinical symptoms, laboratory tests and neuroimaging findings. Eligible patients are screened according to the inclusion and exclusion criteria, and patients treated with edoxaban enter into "Edoxaban" group and with rivaroxaban into "Rivaroxaban" group.
Key inclusion criteria (5 listed)
- Patient aged from 18 to 80 years and no gender preference;
- Diagnosis of CVT as confirmed on MRBTI/MRV or CT/CTV or DSA;
- Acute or subacute CVT from onset to door within 4 weeks;
- The treating clinician irrelevant to the study is of the opinion that the patient is appropriate for edoxaban or rivaroxaban;
- Patient or legally authorized representative is able to give written informed consent.
Key exclusion criteria (14 listed)
- Patient refuse to take edoxaban or rivaroxaban to treat CVT;
- Pregnancy or breastfeeding women at the time of enrollment, or women who plan to get pregnant during study;
- Patient is anticipated to require invasive procedure (e.g. thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation;
- CVT secondary to central nervous system infection or severe head trauma;
- It is in the proliferative stage of malignant tumors currently or within 6 months of diagnosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recanalization of cerebral veins or venous sinuses
Time frame: 1 year
major bleeding events
Time frame: 1 year
1. Symptomatic intracranial bleeding A new symptomatic intracranial hemorrhage OR worsening existing intracranial hemorrhage with a ≥33% change in hematoma volume, AND either an NIHSS score increase of 4 or more points, or a change in level of consciousness as per NIHSS item 1a, AND the clinical change is thought to be attributable to the hemorrhage. 2. Other major bleeding Bleeding in a critical area or organ, including intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a drop in hemoglobin by 20 g/L or more, leading to transfusion of 2 or more units of whole blood or red cells.
2 secondary outcomes
Venous thrombosis or recurrence of CVT
Time frame: 1 year
Death or clinically relevant non-major bleeding events
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Venous Thrombosis and Anticoagulants and Thrombotic Disorders, run by Xuanwu Hospital, Beijing 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 14 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: looking for participants now, as of the sponsor's last update on 27 Apr 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ran Meng (+86-10-83199280, victor65@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recanalization of cerebral veins or venous sinuses (time frame: 1 year). The study lists 2 primary outcomes in all. 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 27 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.