Safety and Efficacy of Edoxaban and Rivaroxaban to Cerebral Venous Thrombosis in Chinese Patients: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,486
- 试验地点
- 1
- 主要终点
- Recanalization of cerebral veins or venous sinuses
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Patient or legally authorized representative is able to give written informed consent.
排除标准
- •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;
- •It is in the proliferative stage of malignant tumors currently or within 6 months of diagnosis;
- •Bleeding diathesis or other contraindication to anticoagulation;
- •Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use;
- •Concomitant use of strong CYP3A4 or P-gp inhibitors;
- •Impaired renal function (CrCl<30 mL/min using Cockcroft-Gault equation) or investigator anticipate the CrCl lower than 30 mL/min during study;
- •Impaired liver function (ALT or AST exceeds twice the normal upper limit) or diagnosed as acute hepatitis currently;
- •Patient is unable to swallow due to depressed level of consciousness or other reasons;
- •Patient has a severe or fatal comorbid illness with life expectancy less than 6 months;
- •Patient with severe hypertension (SBP≥180mmHg and/or DBP≥110mmHg);
- •Patient is known to be allergic to edoxaban or rivaroxaban.
结局指标
主要结局
Recanalization of cerebral veins or venous sinuses
时间窗: 1 year
major bleeding events
时间窗: 1 year
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.
次要结局
- Venous thrombosis or recurrence of CVT(1 year)
- Death or clinically relevant non-major bleeding events(1 year)
研究者
Meng Ran
Professor
Xuanwu Hospital, Beijing