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

Recruiting

• Conditions: Cerebral Venous Thrombosis
• Interventions: Drug: Dabigatran; Drug: Rivaroxaban

• Registration Number: NCT07083609
• Lead Sponsor: Hieu Trung Dinh

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-07
• Study Start: 2025-07-11
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-24
• Last Update Posted: 2025-07-24
• Primary Completion: 2027-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DOAC Group	Dabigatran	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
DOAC Group	Rivaroxaban	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

Primary Outcome Measures

Name	Time	Method
Composite of major bleeding or recurrent venous thromboembolism	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)

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life (EQ-5D-5L utility index score)	At 3 and 6 months after CVT diagnosis	Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument. This tool evaluates five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity.; A utility index score will be calculated using the Vietnamese EQ-5D-5L value set, ranging from -0.511 to 1.000, where: 1.000 indicates perfect health,; 0.000 corresponds to death,; scores below 0 indicate health states considered worse than death by the general Vietnamese population.
Serial D-dimer measurements after CVT	At 3 and 6 months after CVT diagnosis	Plasma D-dimer levels will be measured at 3 and 6 months using a standardized quantitative assay. Values will be reported in ng/mL and interpreted in the context of post-CVT coagulation activity.
Frequency of chronic headache after CVT	At 6 months after CVT diagnosis	Presence and frequency of persistent or recurrent headache fulfilling the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria for chronic post-CVT headache. Assessment will be based on patient-reported symptoms and clinical evaluation
Functional outcome	At 3 and 6 months after after CVT diagnosis	Proportion of patients with good functional outcome, defined as a score of 0-1 on the Modified Rankin Scale (mRS). The Modified Rankin Scale ranges from 0 to 6, where 0 indicates no symptoms and 6 indicates death. Lower scores reflect better functional recovery.
Mortality Rate	At 6 months after CVT diagnosis	All-cause mortality
Number of participants who discontinued anticoagulant therapy early	At 6 months after CVT diagnosis	Number of participants who discontinued DOAC therapy before the duration recommended by their treating physician, and documented reasons for discontinuation (e.g., adverse events, patient decision, or clinical judgment). Reasons will be collected from clinical records and follow-up interviews.
Number of participants with clinically relevant non-major bleeding (CRNMB) events	At 3 and 6 months after CVT diagnosis	Number of CRNMB events, defined according to the criteria established by the International Society on Thrombosis and Haemostasis (ISTH)
Number of participants with symptomatic recurrent venous thromboembolism (VTE)	At 3 and 6 months after CVT diagnosis	Number of participants who experience symptomatic recurrent venous thromboembolism (VTE), including cerebral venous thrombosis, deep vein thrombosis, pulmonary embolism, or splanchnic thrombosis.
Number of participants with arterial thrombotic events	At 6 months after CVT diagnosis	Number of participants who experience arterial thrombotic events, including ischemic stroke, myocardial infarction, or other objectively confirmed arterial thromboses. Events will be confirmed by clinical assessment and/or imaging as appropriate.
Venous recanalization	At 6 months after CVT diagnosis	Degree of venous sinus recanalization assessed on follow-up neuroimaging (MRI/MRV or CT/CTV) at 6 months. Recanalization will be categorized as complete, partial, or absent, based on standardized radiological criteria
Number of participants with major bleeding events	At 3 and 6 months after CVT diagnosis	Number of major bleeding events, defined according to the criteria established by the International Society on Thrombosis and Haemostasis (ISTH).

Trial Locations

Locations (1)

Bach Mai Hospital; 🇻🇳 Hanoi, Vietnam