Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis: A Prospective Observational Study in Vietnam

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Viet Nam
Bach Mai Hospital
RECRUITING
Hanoi
Contact Information
Primary
Hieu T. Dinh, MD
dr.dinhhieu1092@gmail.com
+84982591092
Time Frame
Start Date: 2025-07-11
Estimated Completion Date: 2027-12
Participants
Target number of participants: 69
Treatments
DOAC Group
Adult patients with radiologically confirmed cerebral venous thrombosis who received therapeutic-dose heparin during the acute phase and subsequently initiated treatment with a direct oral anticoagulant (dabigatran or rivaroxaban) between 5 and 15 days after the start of heparin therapy
Sponsors
Leads: Hieu Trung Dinh

This content was sourced from clinicaltrials.gov