Safety and Efficacy of Edoxaban and Rivaroxaban to Cerebral Venous Thrombosis in Chinese Patients

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?

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 Overview

• Status: Recruiting
• Conditions: Cerebral Venous Thrombosis; Anticoagulant Therapy; Anticoagulant Drugs; Anticoagulation With NOAC; Anticoagulation Treatment; NOACs; Anticoagulation With Direct Oral Anticoagulants; Anticoagulant Prophylaxis/Therapy; Anticoagulants and Thrombotic Disorders

• Study Type: Observational
• Enrollment (Estimated): 1486

Contacts and Locations

• Study Contact: Name: Ran Meng; Phone Number: +86-10-83199280; Email: victor65@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Da Zhou; Phone Number: +86-10-83199280; Email: popdoctor@foxmail.com
      • Contact: Guangyu Han

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. Patient aged from 18 to 80 years and no gender preference;
2. Diagnosis of CVT as confirmed on MRBTI/MRV or CT/CTV or DSA;
3. Acute or subacute CVT from onset to door within 4 weeks;
4. The treating clinician irrelevant to the study is of the opinion that the patient is appropriate for edoxaban or rivaroxaban;
5. Patient or legally authorized representative is able to give written informed consent.

Exclusion Criteria:

1. Patient refuse to take edoxaban or rivaroxaban to treat CVT;
2. Pregnancy or breastfeeding women at the time of enrollment, or women who plan to get pregnant during study;
3. Patient is anticipated to require invasive procedure (e.g. thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation;
4. CVT secondary to central nervous system infection or severe head trauma;
5. It is in the proliferative stage of malignant tumors currently or within 6 months of diagnosis;
6. Bleeding diathesis or other contraindication to anticoagulation;
7. Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use;
8. Concomitant use of strong CYP3A4 or P-gp inhibitors;
9. Impaired renal function (CrCl<30 mL/min using Cockcroft-Gault equation) or investigator anticipate the CrCl lower than 30 mL/min during study;
10. Impaired liver function (ALT or AST exceeds twice the normal upper limit) or diagnosed as acute hepatitis currently;
11. Patient is unable to swallow due to depressed level of consciousness or other reasons;
12. Patient has a severe or fatal comorbid illness with life expectancy less than 6 months;
13. Patient with severe hypertension (SBP≥180mmHg and/or DBP≥110mmHg);
14. Patient is known to be allergic to edoxaban or rivaroxaban.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Rivaroxaban
edoxaban

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recanalization of cerebral veins or venous sinuses		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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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).	1 year

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 20, 2025
• First Submitted That Met QC Criteria: April 20, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: RMeng2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No