Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

More Cerebral Venous Thrombosis trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment69 (estimated)
SponsorBach Mai Hospital
Academic / other
Locations1 site (Hanoi, Hanoi)
StatusRecruiting
StartedJuly 11, 2025
Main results expectedDecember 2027
Study endsDecember 2027
Registry record updatedOctober 9, 2026
Trial IDNCT07083609 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.