Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT06947707

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

Led by Xuanwu Hospital, Beijing · Updated on 2025-04-27

1486

Participants Needed

1

Research Sites

142 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years, any gender
  • Diagnosis of cerebral venous thrombosis confirmed by MRBTI/MRV, CT/CTV, or DSA
  • Acute or subacute CVT with onset to hospital visit within 4 weeks
  • Treating clinician considers patient appropriate for edoxaban or rivaroxaban treatment
  • Patient or legal representative able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Refusal to take edoxaban or rivaroxaban for CVT treatment
  • Pregnant or breastfeeding women, or women planning pregnancy during the study
  • Expected need for invasive procedure before starting oral anticoagulation
  • CVT caused by central nervous system infection or severe head trauma
  • Active malignant tumors or within 6 months of diagnosis
  • Bleeding disorders or other reasons that contraindicate anticoagulation
  • Medical conditions requiring mandatory antiplatelet or anticoagulant therapy
  • Use of strong CYP3A4 or P-gp inhibitors
  • Severe kidney impairment (creatinine clearance less than 30 mL/min) or expected to decline
  • Severe liver impairment or current acute hepatitis
  • Unable to swallow medications due to consciousness or other issues
  • Severe or life-threatening illness with life expectancy under 6 months
  • Severe high blood pressure (systolic ≥180 mmHg or diastolic ≥110 mmHg)
  • Known allergy to edoxaban or rivaroxaban

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100053

Actively Recruiting

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Research Team

R

Ran Meng

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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