Actively Recruiting
Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis in Vietnam
Led by Hieu Trung Dinh · Updated on 2025-07-24
69
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis in Vietnam
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent to participate in the study
- Age 18 years or older
- Confirmed diagnosis of cerebral venous thrombosis based on clinical presentation and neuroimaging (MRI and MRV, and/or CT and CTV, and/or MRI or CT combined with DSA)
- Initiation of direct oral anticoagulants within 5 to 15 days after starting heparin treatment
You will not qualify if you...
- Cerebral venous thrombosis with antiphospholipid syndrome meeting all three laboratory criteria: lupus anticoagulant, anticardiolipin antibodies, and anti-2-glycoprotein antibodies
- Cerebral venous thrombosis in pregnant patients requiring continuous anticoagulation throughout pregnancy
- Cerebral venous thrombosis with bleeding disorders including immune thrombocytopenia with platelet count below 100,000/mL, hemophilia A or B, von Willebrand disease, or history of prolonged bleeding after surgery or invasive procedures
- Cerebral venous thrombosis in patients with mechanical heart valves, atrial fibrillation, or moderate to severe mitral stenosis
- Cerebral venous thrombosis in patients with glomerular filtration rate below 15 mL/min
- Cerebral venous thrombosis with severe liver impairment
- Patients already receiving anticoagulation therapy for other underlying conditions at the time of cerebral venous thrombosis diagnosis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Bach Mai Hospital
Hanoi, Vietnam, 100000
Actively Recruiting
Research Team
H
Hieu T. Dinh, MD
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
1
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