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

Launched by XUANWU HOSPITAL, BEIJING · Apr 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of two blood-thinning medications, edoxaban and rivaroxaban, in treating a condition called cerebral venous thrombosis (CVT) in Chinese patients aged 18 to 80. The study aims to find out if these medications can help the veins in the brain reopen during treatment and whether any bleeding problems occur while patients are taking these drugs.

To participate in this trial, patients need to be diagnosed with CVT and must be willing to take either edoxaban or rivaroxaban as directed by their doctor. Participants will be asked to come back for follow-up visits at 3, 6, 9, and 12 months after starting treatment to check their progress. It’s important to know that certain individuals, such as pregnant women or those with specific health conditions, may not be eligible to join the study. Overall, this research is crucial for understanding how these medications can help patients with CVT.

Gender

ALL

Eligibility criteria

• 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.