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

NCT07083609 | Recruiting

• 3 other identifiers: DOAC-CVT-VN2025-BMH45-BM-HDDD580-QD-DHYHN
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Venous Thrombosis

Keywords

cerebral venous thrombosis; direct oral anticoagulants; rivaroxaban; dabigatran; major bleeding; recurrent VTE; modified Rankin Scale; quality of life; prospective cohort; observational study

Outcome Measures

Primary Outcomes (1)

• Composite of major bleeding or recurrent venous thromboembolism

  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)

  Within 6 months after CVT diagnosis

Secondary Outcomes (11)

• Mortality Rate

  At 6 months after CVT diagnosis

• Functional outcome

  At 3 and 6 months after after CVT diagnosis

• Number of participants with major bleeding events

  At 3 and 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

Study Arms (1)

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

Drug: Dabigatran; Drug: Rivaroxaban

Interventions

Dabigatran DRUG

Dabigatran will be initiated between 5 and 15 days after therapeutic-dose heparin in patients with cerebral venous thrombosis (CVT), based on clinical judgment. It is administered as part of routine clinical care.

Also known as: Pradaxa

DOAC Group

Rivaroxaban DRUG

Rivaroxaban will be initiated between 5 and 15 days after therapeutic-dose heparin in patients with cerebral venous thrombosis (CVT), based on clinical judgment. It is administered as part of routine clinical care.

Also known as: Xarelto

DOAC Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years old) with radiologically confirmed cerebral venous thrombosis (CVT) who received therapeutic-dose heparin during the acute phase and are subsequently treated with a direct oral anticoagulant. All participants will be recruited from Bach Mai Hospital, the national referral center in Vietnam that receives the majority of CVT cases in the northern region.

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

Sponsors & Collaborators

• Hieu Trung Dinh: lead

Study Sites (1)

Bach Mai Hospital

Hanoi, 100000, Vietnam

RECRUITING

Related Publications (17)

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MeSH Terms

Conditions

Intracranial Thrombosis

Interventions

Dabigatran; Rivaroxaban

Condition Hierarchy (Ancestors)

Intracranial Embolism and Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Study Officials

• Ton D. Mai

  Hanoi Medical University

  STUDY CHAIR

Central Study Contacts

Hieu T. Dinh, MD

CONTACT

+84982591092; dr.dinhhieu1092@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 24, 2025
• Study Start: July 11, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)