Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis in Vietnam (DCVT-VN25)

Hieu Trung Dinh

Status: Enrolling

Conditions: Cerebral Venous Thrombosis

Treatments: Drug: Rivaroxaban; Drug: Dabigatran

Study type: Observational

Funder types: Other

Identifiers

NCT07083609

45-BM-HDDD (Other Identifier)

DOAC-CVT-VN2025-BMH

580-QD-DHYHN (Other Identifier)

Details and patient eligibility

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.

Full description

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

Neuroimaging for venous sinus recanalization

Functional status (Modified Rankin Scale)

Health-related quality of life (EQ-5D-5L)

Safety outcomes including major bleeding, CRNMB, symptomatic recurrent VTE, arterial events, and chronic headache

Early treatment discontinuation and its causes (e.g., adverse events, patient decision)

Findings from this study will contribute important real-world evidence to guide clinical practice, especially in Asian populations underrepresented in existing prospective research.

Enrollment: 69 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

69 participants in 1 patient group

DOAC Group

Description:

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

Treatment:

Drug: Dabigatran

Drug: Rivaroxaban