NCT07083609 Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis in Vietnam
| NCT ID | NCT07083609 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hieu Trung Dinh |
| Condition | Cerebral Venous Thrombosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 69 participants |
| Start Date | 2025-07-11 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 69 participants in total. It began in 2025-07-11 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Ton D. Mai
STUDY CHAIR
Hanoi Medical University
Frequently Asked Questions
Who can join the NCT07083609 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cerebral Venous Thrombosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07083609 currently recruiting?
Yes, NCT07083609 is actively recruiting participants. Contact the research team at dr.dinhhieu1092@gmail.com for enrollment information.
Where is the NCT07083609 trial being conducted?
This trial is being conducted at Hanoi, Vietnam.
Who is sponsoring the NCT07083609 clinical trial?
NCT07083609 is sponsored by Hieu Trung Dinh. The principal investigator is Ton D. Mai at Hanoi Medical University. The trial plans to enroll 69 participants.