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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Xuanwu Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Ran Meng
• Email: victor65@126.com
• Phone: +86-10-83199280

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Danang Cerebral Venous Thrombosis Registry

  This registry collects information on adults with cerebral venous thrombosis admitted to Danang Hospital to see how the condition presents, what imaging shows, risk factors, and how patients recover.

  Recruiting Da Nang Hospital · Da Nang, Da Nang · NCT07890675

• Anticoagulation Plus Tocilizumab for Acute Cerebral Venous Thrombosis

  This study tests whether adding a single dose of tocilizumab to standard blood thinners helps people with acute cerebral venous thrombosis.

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• Optimizing Anticoagulation in Pregnancies With Mechanical Heart Valves

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• Left atrial appendage closure with AtriLASH Seralene suture during cardiac surgery for atrial fibrillation

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  Recruiting Institute of Cardiovascular Diseases, Vojvodina · Kamenitz, Vojvodina · NCT07360899

• Anticoagulation plus batroxobin for acute cerebral venous thrombosis

  This trial tests whether adding batroxobin to standard anticoagulation helps adults with acute cerebral venous thrombosis.

  Recruiting Phase 4 Xuanwu Hospital, Beijing · Beijing, Beijing Municipality · NCT07352358

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.