Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis: A Prospective Observational Study in Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Composite of major bleeding or recurrent venous thromboembolism
研究概览
简要总结
This prospective, single-arm observational cohort study aims to evaluate the real-world effectiveness and safety of direct oral anticoagulants (DOACs), specifically dabigatran or rivaroxaban, in patients with cerebral venous thrombosis (CVT). The study will be conducted at Bach Mai Hospital, a national tertiary stroke referral center in Hanoi, Vietnam.
A minimum of 69 adults with radiologically confirmed CVT will be enrolled between June 2025 and June 2027. All participants must have received therapeutic-dose heparin during the acute phase and will be transitioned to a DOAC within 5 to 15 days, per physician judgment. All treatments are part of routine care; no investigational drugs are used.
The primary outcome is a composite of major bleeding (per ISTH criteria) or recurrent venous thromboembolism (VTE) within 6 months.
Secondary outcomes include: functional outcome (Modified Rankin Scale), venous sinus recanalization, all-cause mortality, serial D-dimer levels, post-CVT chronic headache, health-related quality of life (EQ-5D-5L), clinically relevant non-major bleeding (CRNMB), symptomatic recurrent VTE, arterial thrombotic events, and early treatment discontinuation.
This study aims to generate real-world data supporting DOAC use in CVT, particularly in Asian populations where prospective evidence is limited.
详细描述
Cerebral venous thrombosis (CVT) is an uncommon yet potentially life-threatening cerebrovascular condition. Direct oral anticoagulants (DOACs) are increasingly adopted for CVT management, supported by recent trials (e.g., RESPECT-CVT, CHOICE-CVT, SECRET) and observational cohorts. However, prospective real-world data, especially in low- and middle-income countries like Vietnam, remain scarce.
This single-center, prospective, single-arm observational study aims to assess the safety and effectiveness of DOACs (dabigatran or rivaroxaban) in routine clinical practice among CVT patients at Bach Mai Hospital-a leading tertiary referral center in northern Vietnam.
Eligible participants are adults (≥18 years) with radiologically confirmed CVT who received therapeutic-dose heparin during the acute phase and are transitioned to a DOAC between days 5 and 15. Patients will be followed for 6 months, with scheduled evaluations of:
Clinical outcomes
D-dimer levels
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent (ICF) to participate in the study
- •Age ≥ 18 years
- •Confirmed diagnosis of cerebral venous thrombosis (CVT) based on clinical presentation and neuroimaging, including one or more of the following:
- •MRI and MRV, AND/OR CT and CTV, AND/OR MRI or CT combined with DSA
- •Initiation of DOACs within 5 to 15 days after starting treatment with heparin
排除标准
- •CVT accompanied by antiphospholipid syndrome with all three positive laboratory criteria: lupus anticoagulant, anticardiolipin antibodies, and anti-β2-glycoprotein antibodies
- •CVT in pregnant patients requiring continuous anticoagulation throughout pregnancy
- •CVT with coexisting bleeding disorders, including immune thrombocytopenia with platelet count <100,000/mL, hemophilia A or B, von Willebrand disease, or a history of prolonged bleeding after surgery or invasive procedures
- •CVT in patients with mechanical heart valves, atrial fibrillation, and moderate to severe mitral stenosis
- •CVT in patients with a glomerular filtration rate (GFR) <15 mL/min
- •CVT with severe hepatic impairment
- •Patients already receiving anticoagulation therapy for another underlying condition at the time of CVT diagnosis
研究组 & 干预措施
DOAC Group
Adult patients with radiologically confirmed cerebral venous thrombosis who received therapeutic-dose heparin during the acute phase and subsequently initiated treatment with a direct oral anticoagulant (dabigatran or rivaroxaban) between 5 and 15 days after the start of heparin therapy
干预措施: Dabigatran (Drug)
DOAC Group
Adult patients with radiologically confirmed cerebral venous thrombosis who received therapeutic-dose heparin during the acute phase and subsequently initiated treatment with a direct oral anticoagulant (dabigatran or rivaroxaban) between 5 and 15 days after the start of heparin therapy
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
Composite of major bleeding or recurrent venous thromboembolism
时间窗: Within 6 months after CVT diagnosis
A composite endpoint including: (1) the occurrence of VTE, defined as recurrent CVT, deep vein thrombosis of any limb, pulmonary embolism, or thrombosis involving the splanchnic, jugular, caval, renal, or catheter-related veins; and (2) major bleeding events, defined according to the criteria established by the International Society on Thrombosis and Haemostasis (ISTH)
次要结局
- Health-related quality of life (EQ-5D-5L utility index score)(At 3 and 6 months after CVT diagnosis)
- Serial D-dimer measurements after CVT(At 3 and 6 months after CVT diagnosis)
- Frequency of chronic headache after CVT(At 6 months after CVT diagnosis)
- Functional outcome(At 3 and 6 months after after CVT diagnosis)
- Mortality Rate(At 6 months after CVT diagnosis)
- Number of participants who discontinued anticoagulant therapy early(At 6 months after CVT diagnosis)
- Number of participants with clinically relevant non-major bleeding (CRNMB) events(At 3 and 6 months after CVT diagnosis)
- Number of participants with symptomatic recurrent venous thromboembolism (VTE)(At 3 and 6 months after CVT diagnosis)
- Number of participants with arterial thrombotic events(At 6 months after CVT diagnosis)
- Venous recanalization(At 6 months after CVT diagnosis)
- Number of participants with major bleeding events(At 3 and 6 months after CVT diagnosis)
研究者
Hieu Trung Dinh
Principal Investigator
Bach Mai Hospital