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

ConditionCerebral Venous Thrombosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHieu Trung Dinh

About this trial

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 the first 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent (ICF) to participate in the study

Age ≥ 18 years

Initiation of DOACs within the first 15 days after starting treatment with heparin

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Dabigatran

    Drug

    Dabigatran will be initiated within the first 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.

  • Rivaroxaban

    Drug

    Rivaroxaban will be initiated within the first 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.

Treatment groups

69 Participants
are divided into 1 treatment group
Group A: DOAC Group2 interventions

Trial outcomes

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)

Time frame
Within 6 months after CVT diagnosis

Secondary outcomes

1

Mortality Rate

All-cause mortality

Time frame
At 6 months after CVT diagnosis
2

Functional outcome

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.

Time frame
At 3 and 6 months after after CVT diagnosis
3

Number of participants with major bleeding events

Number of major bleeding events, defined according to the criteria established by the International Society on Thrombosis and Haemostasis (ISTH).

Time frame
At 3 and 6 months after CVT diagnosis
4

Number of participants with clinically relevant non-major bleeding (CRNMB) events

Number of CRNMB events, defined according to the criteria established by the International Society on Thrombosis and Haemostasis (ISTH)

Time frame
At 3 and 6 months after CVT diagnosis

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hieu Trung Dinh

Lead sponsor

Bach Mai Hospital

Sponsor institution

Source ClinicalTrials.gov
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