DOAC treatment outcomes for cerebral venous thrombosis in Vietnam
Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis: A Prospective Observational Study in Vietnam
This project will try direct oral anticoagulants (dabigatran or rivaroxaban) in adults with cerebral venous thrombosis to see if they are safe and effective in routine care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 69 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bach Mai Hospital Academic / other |
| Locations | 1 site (Hanoi) |
| Trial ID | NCT07083609 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm observational cohort conducted at Bach Mai Hospital, a national tertiary stroke referral center in Hanoi. At least 69 adults with radiologically confirmed cerebral venous thrombosis who received therapeutic-dose heparin acutely and are transitioned to dabigatran or rivaroxaban between days 5 and 15 will be enrolled and followed for 6 months. All treatments are prescribed as part of routine care and no investigational drugs are used; participants will have scheduled clinical visits, laboratory testing (including serial D-dimer), and neuroimaging to document outcomes. The primary outcome is a composite of major bleeding or recurrent venous thromboembolism within 6 months, with secondary outcomes including functional status (mRS), venous sinus recanalization, mortality, quality of life, and other safety endpoints.
Who should consider this trial
Good fit: Adults (≥18 years) with radiologically confirmed CVT who received therapeutic-dose heparin in the acute phase and are switched to dabigatran or rivaroxaban between days 5 and 15 are eligible.
Not a fit: Patients with triple-positive antiphospholipid syndrome, ongoing pregnancy requiring continuous anticoagulation, major bleeding disorders, mechanical heart valves, or other listed exclusion conditions are unlikely to be included or benefit from this protocol.
Why it matters
Potential benefit: If successful, the study could support the use of DOACs as a safe and practical alternative to conventional therapy for CVT in routine clinical practice in Vietnam.
How similar studies have performed: Randomized trials (e.g., RESPECT-CVT, CHOICE-CVT) and several observational cohorts have reported that DOACs can be safe and effective for CVT, but prospective real-world data from low- and middle-income settings remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hanoi
- Bach Mai Hospital — Hanoi, Vietnam (Recruiting)
Study contacts
- Study coordinator: Hieu T. Dinh, MD
- Email: dr.dinhhieu1092@gmail.com
- Phone: +84982591092
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.