Evaluating the safety and effectiveness of edoxaban and rivaroxaban for treating cerebral venous thrombosis in Chinese patients

Safety and Efficacy of Edoxaban and Rivaroxaban to Cerebral Venous Thrombosis in Chinese Patients: A Prospective Cohort Study

This study is testing whether two blood thinners, edoxaban and rivaroxaban, are safe and effective for treating cerebral venous thrombosis in Chinese patients aged 18 to 80.

Quick facts

• Study type: Observational
• Enrollment: 1486 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06947707 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the safety and efficacy of two anticoagulants, edoxaban and rivaroxaban, in treating cerebral venous thrombosis (CVT) among Chinese patients aged 18 to 80. Participants will be monitored for the recanalization of cerebral veins or venous sinuses and any bleeding events during treatment. They will adhere to a prescribed medication regimen and attend follow-up assessments at 3, 6, 9, and 12 months post-enrollment to evaluate treatment outcomes. The study seeks to provide insights into the effectiveness of these anticoagulants in a specific population.

Who should consider this trial

Good fit: Ideal candidates include Chinese patients aged 18 to 80 diagnosed with acute or subacute cerebral venous thrombosis.

Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to anticoagulation will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the safety and effectiveness of edoxaban and rivaroxaban for treating CVT, potentially improving patient outcomes.

How similar studies have performed: While there have been studies on anticoagulants for CVT, this specific observational approach focusing on edoxaban and rivaroxaban in the Chinese population is relatively novel.

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.

Where this trial is running

Beijing, Beijing Municipality

• Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Ran Meng

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