Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis in Vietnam

Recruiting now

Conditions studied: Cerebral Venous Thrombosis

In brief

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.

Key facts

Study ID: NCT07083609
Run by: Hieu Trung Dinh
People needed: 69
Starts: 2025-07-11
Expected to finish: 2027-12-01
Last updated by the study team: 2025-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Bach Mai Hospital — Hanoi, Vietnam (enrolling)

Full record on ClinicalTrials.gov

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