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

NCT06947707 | Recruiting

• 1 other identifier: RMeng2
• Study Type: observational
• Target: 1,486
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Recanalization of cerebral veins or venous sinuses

  1 year

• major bleeding events

  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.

  1 year

Secondary Outcomes (2)

• Venous thrombosis or recurrence of CVT

  1 year

• Death or clinically relevant non-major bleeding events

  1 year

Study Arms (2)

edoxaban

Rivaroxaban

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Intracranial Thrombosis

Condition Hierarchy (Ancestors)

Intracranial Embolism and Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Embolism and Thrombosis

Central Study Contacts

Ran Meng

CONTACT

+86-10-83199280; victor65@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: April 27, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)