DOAC treatment outcomes for cerebral venous thrombosis in Vietnam
Official title: Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis: A Prospective Observational Study in Vietnam
Run by Bach Mai Hospital · NCT07083609 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 69 (estimated) |
| Sponsor | Bach Mai Hospital Academic / other |
| Locations | 1 site (Hanoi, Hanoi) |
| Status | Recruiting |
| Started | July 11, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT07083609 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 the first 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 it's running
-
Bach Mai Hospital
Hanoi, Hanoi, Vietnam Recruiting
Study contacts
- Study coordinator: Hieu T. Dinh, MD
- Email: dr.dinhhieu1092@gmail.com
- Phone: +84982591092
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Danang Cerebral Venous Thrombosis Registry
This registry collects information on adults with cerebral venous thrombosis admitted to Danang Hospital to see how the condition presents, what imaging shows, risk factors, and how patients recover.
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Anticoagulation Plus Tocilizumab for Acute Cerebral Venous Thrombosis
This study tests whether adding a single dose of tocilizumab to standard blood thinners helps people with acute cerebral venous thrombosis.
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Anticoagulation plus batroxobin for acute cerebral venous thrombosis
This trial tests whether adding batroxobin to standard anticoagulation helps adults with acute cerebral venous thrombosis.
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Evaluating the safety and effectiveness of edoxaban and rivaroxaban for treating cerebral venous thrombosis in Chinese patients
This study is testing whether two blood thinners, edoxaban and rivaroxaban, are safe and effective for treating cerebral venous thrombosis in Chinese patients aged 18 to 80.
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Using direct oral anticoagulants to treat cerebral venous thrombosis
This study is testing whether a new type of blood thinner called direct oral anticoagulants can safely and effectively treat people with cerebral venous thrombosis.
-
Endovascular treatment plus anticoagulation for severe CVST in the MENA region
This trial tests whether adding endovascular thrombectomy to standard anticoagulation helps adults with severe cerebral venous sinus thrombosis see better outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.