About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged from 18 to 80 years and no gender preference;
Diagnosis of CVT as confirmed on MRBTI/MRV or CT/CTV or DSA;
Acute or subacute CVT from onset to door within 4 weeks;
The treating clinician irrelevant to the study is of the opinion that the patient is appropriate for edoxaban or rivaroxaban;
Disqualifiers
Patient refuse to take edoxaban or rivaroxaban to treat CVT;
Pregnancy or breastfeeding women at the time of enrollment, or women who plan to get pregnant during study;
Patient is anticipated to require invasive procedure (e.g. thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation;
CVT secondary to central nervous system infection or severe head trauma;
Trial population
All patients with suspected CVT visited Xuanwu Hospital, Capital Medical University are evaluated from clinical symptoms, laboratory tests and neuroimaging findings. Eligible patients are screened according to the inclusion and exclusion criteria, and patients treated with edoxaban enter into "Edoxaban" group and with rivaroxaban into "Rivaroxaban" group.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Recanalization of cerebral veins or venous sinuses
major bleeding events
1. Symptomatic intracranial bleeding A new symptomatic intracranial hemorrhage OR worsening existing intracranial hemorrhage with a ≥33% change in hematoma volume, AND either an NIHSS score increase of 4 or more points, or a change in level of consciousness as per NIHSS item 1a, AND the clinical change is thought to be attributable to the hemorrhage. 2. Other major bleeding Bleeding in a critical area or organ, including intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a drop in hemoglobin by 20 g/L or more, leading to transfusion of 2 or more units of whole blood or red cells.
Secondary outcomes
Venous thrombosis or recurrence of CVT
Venous thrombosis (including deep vein thrombosis or pulmonary embolism or visceral vein thrombosis) or recurrence of CVT (including new-onset CVT or progression of previous CVT)
Death or clinically relevant non-major bleeding events
Death related to venous thrombosis events or from other causes. A clinically relevant non-major bleeding event is an acute or subacute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of: (a) a hospital admission for bleeding, or (b) a physician guided medical or surgical treatment for bleeding, or (c) a change in antithrombotic therapy (including interruption or discontinuation of study drug).
Sponsors and contacts
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