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

Capital Medical University

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06947707

RMeng2

Details and patient eligibility

About

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.

Enrollment: 1,486 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,486 participants in 2 patient groups

edoxaban

Rivaroxaban