Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis in Vietnam
NCT ID: NCT07083609
Last Updated: 2025-07-24
Study Results
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Basic Information
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RECRUITING
69 participants
OBSERVATIONAL
2025-07-11
2027-12-31
Brief Summary
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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.
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Detailed Description
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This single-center, prospective, single-arm observational study aims to assess the safety and effectiveness of DOACs (dabigatran or rivaroxaban) in routine clinical practice among CVT patients at Bach Mai Hospital-a leading tertiary referral center in northern Vietnam.
Eligible participants are adults (≥18 years) with radiologically confirmed CVT who received therapeutic-dose heparin during the acute phase and are transitioned to a DOAC between days 5 and 15. Patients will be followed for 6 months, with scheduled evaluations of:
Clinical outcomes
D-dimer levels
Neuroimaging for venous sinus recanalization
Functional status (Modified Rankin Scale)
Health-related quality of life (EQ-5D-5L)
Safety outcomes including major bleeding, CRNMB, symptomatic recurrent VTE, arterial events, and chronic headache
Early treatment discontinuation and its causes (e.g., adverse events, patient decision)
Findings from this study will contribute important real-world evidence to guide clinical practice, especially in Asian populations underrepresented in existing prospective research.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Dabigatran
Dabigatran will be initiated between 5 and 15 days after therapeutic-dose heparin in patients with cerebral venous thrombosis (CVT), based on clinical judgment. It is administered as part of routine clinical care.
Rivaroxaban
Rivaroxaban will be initiated between 5 and 15 days after therapeutic-dose heparin in patients with cerebral venous thrombosis (CVT), based on clinical judgment. It is administered as part of routine clinical care.
Interventions
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Dabigatran
Dabigatran will be initiated between 5 and 15 days after therapeutic-dose heparin in patients with cerebral venous thrombosis (CVT), based on clinical judgment. It is administered as part of routine clinical care.
Rivaroxaban
Rivaroxaban will be initiated between 5 and 15 days after therapeutic-dose heparin in patients with cerebral venous thrombosis (CVT), based on clinical judgment. It is administered as part of routine clinical care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Hieu Trung Dinh
OTHER
Responsible Party
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Hieu Trung Dinh
Principal Investigator
Principal Investigators
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Ton D. Mai
Role: STUDY_CHAIR
Hanoi Medical University
Locations
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Bach Mai Hospital
Hanoi, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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References
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Mai VQ, Sun S, Minh HV, Luo N, Giang KB, Lindholm L, Sahlen KG. An EQ-5D-5L Value Set for Vietnam. Qual Life Res. 2020 Jul;29(7):1923-1933. doi: 10.1007/s11136-020-02469-7. Epub 2020 Mar 27.
Kaatz S, Ahmad D, Spyropoulos AC, Schulman S; Subcommittee on Control of Anticoagulation. Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH. J Thromb Haemost. 2015 Nov;13(11):2119-26. doi: 10.1111/jth.13140. No abstract available.
Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.
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Saposnik G, Bushnell C, Coutinho JM, Field TS, Furie KL, Galadanci N, Kam W, Kirkham FC, McNair ND, Singhal AB, Thijs V, Yang VXD; American Heart Association Stroke Council; Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; Council on Cardiovascular and Stroke Nursing; and Council on Hypertension. Diagnosis and Management of Cerebral Venous Thrombosis: A Scientific Statement From the American Heart Association. Stroke. 2024 Mar;55(3):e77-e90. doi: 10.1161/STR.0000000000000456. Epub 2024 Jan 29.
van de Munckhof A, van Kammen MS, Tatlisumak T, Krzywicka K, Aaron S, Antochi F, Arauz A, Barboza MA, Conforto AB, Contreras DG, Heldner MR, Hernandez-Perez M, Hiltunen S, Ji X, Kam W, Kleinig TJ, Kristoffersen ES, Leker RR, Lemmens R, Poli S, Wasay M, Wu T, Yesilot N, Chen J, Cotelli MS, Demeestere J, Duan J, Ergin N, Freitas TE, Gomes A, den Hertog HM, Lindgren E, Martinez-Majander N, Metanis I, Miraclin A, Rani LJ, Reddy YM, Saleem S, Scutelnic A, Shanmugasundaram S, van den Wijngaard IR, Gencdal IY, van Eekelen R, Vellema J, Arnold M, Neto L, Middeldorp S, de Sousa DA, Jood K, Putaala J, Ferro JM, Coutinho JM; DOAC-CVT investigators. Direct oral anticoagulants versus vitamin K antagonists for cerebral venous thrombosis (DOAC-CVT): an international, prospective, observational cohort study. Lancet Neurol. 2025 Mar;24(3):199-207. doi: 10.1016/S1474-4422(24)00519-2.
Yaghi S, Shu L, Bakradze E, Salehi Omran S, Giles JA, Amar JY, Henninger N, Elnazeir M, Liberman AL, Moncrieffe K, Lu J, Sharma R, Cheng Y, Zubair AS, Simpkins AN, Li GT, Kung JC, Perez D, Heldner M, Scutelnic A, Seiffge D, Siepen B, Rothstein A, Khazaal O, Do D, Kasab SA, Rahman LA, Mistry EA, Kerrigan D, Lafever H, Nguyen TN, Klein P, Aparicio H, Frontera J, Kuohn L, Agarwal S, Stretz C, Kala N, El Jamal S, Chang A, Cutting S, Xiao H, de Havenon A, Muddasani V, Wu T, Wilson D, Nouh A, Asad SD, Qureshi A, Moore J, Khatri P, Aziz Y, Casteigne B, Khan M, Cheng Y, Mac Grory B, Weiss M, Ryan D, Vedovati MC, Paciaroni M, Siegler JE, Kamen S, Yu S, Leon Guerrero CR, Atallah E, De Marchis GM, Brehm A, Dittrich T, Psychogios M, Alvarado-Dyer R, Kass-Hout T, Prabhakaran S, Honda T, Liebeskind DS, Furie K. Direct Oral Anticoagulants Versus Warfarin in the Treatment of Cerebral Venous Thrombosis (ACTION-CVT): A Multicenter International Study. Stroke. 2022 Mar;53(3):728-738. doi: 10.1161/STROKEAHA.121.037541. Epub 2022 Feb 10.
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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45-BM-HDDD
Identifier Type: OTHER
Identifier Source: secondary_id
580-QD-DHYHN
Identifier Type: OTHER
Identifier Source: secondary_id
DOAC-CVT-VN2025-BMH
Identifier Type: -
Identifier Source: org_study_id
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