Cerebral Venous ThrombosisDCVT-VN25NCT07083609
Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis in Vietnam
An observational study of Cerebral Venous Thrombosis, run by Hieu Trung Dinh at 1 site in Vietnam.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Venous Thrombosis
- What is being tested?
- Dabigatran and Rivaroxaban
- Type of treatment
- Pill or oral medicine
- How many people
- 69 participants
- Where
- 1 siteVietnam
- Study dates
- 11 Jul 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years old) with radiologically confirmed cerebral venous thrombosis (CVT) who received therapeutic-dose heparin during the acute phase and are subsequently treated with a direct oral anticoagulant. All participants will be recruited from Bach Mai Hospital, the national referral center in Vietnam that receives the majority of CVT cases in the northern region.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Bach Mai Hospital
Hanoi, Hanoi, 100000
Hieu T. Dinh, MD, +84982591092, dr.dinhhieu1092@gmail.com
About this study
Official title: Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis: A Prospective Observational Study in Vietnam
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 the first 15 days, per physician judgment. All treatments are part of routine care; no investigational drugs are used.
Read more
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.
Read the detailed description
Cerebral venous thrombosis (CVT) is an uncommon yet potentially life-threatening cerebrovascular condition. Direct oral anticoagulants (DOACs) are increasingly adopted for CVT management, supported by recent trials (e.g., RESPECT-CVT, CHOICE-CVT, SECRET) and observational cohorts. However, prospective real-world data, especially in low- and middle-income countries like Vietnam, remain scarce.
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 within the first 15 days. 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
- Cerebral Venous Thrombosis
- Being tested
- Dabigatran, Rivaroxaban
- Keywords
- cerebral venous thrombosis, direct oral anticoagulants, rivaroxaban, dabigatran, major bleeding, recurrent VTE, modified Rankin Scale, quality of life, prospective cohort, observational study
- Medical subject headings
- Intracranial Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabigatranDrug
Also called Pradaxa
Dabigatran will be initiated within the first 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.
RivaroxabanDrug
Also called Xarelto
Rivaroxaban will be initiated within the first 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) within the first 15 days after the start of heparin therapy Receives: Drug: Dabigatran; Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of major bleeding or recurrent venous thromboembolism
A composite endpoint including: (1) the occurrence of VTE, defined as recurrent CVT, deep vein thrombosis of any limb, pulmonary embolism, or thrombosis involving the splanchnic, jugular, caval, renal, or catheter-related veins; and (2) major bleeding events, defined according to the criteria established by the International Society on Thrombosis and Haemostasis (ISTH)
Measured: Within 6 months after CVT diagnosis
Secondary outcomes (11)
Mortality Rate
All-cause mortality
Measured: At 6 months after CVT diagnosis
Functional outcome
Proportion of patients with good functional outcome, defined as a score of 0-1 on the Modified Rankin Scale (mRS). The Modified Rankin Scale ranges from 0 to 6, where 0 indicates no symptoms and 6 indicates death. Lower scores reflect better functional recovery.
Measured: At 3 and 6 months after after CVT diagnosis
Number of participants with major bleeding events
Number of major bleeding events, defined according to the criteria established by the International Society on Thrombosis and Haemostasis (ISTH).
Measured: At 3 and 6 months after CVT diagnosis
Number of participants with clinically relevant non-major bleeding (CRNMB) events
Number of CRNMB events, defined according to the criteria established by the International Society on Thrombosis and Haemostasis (ISTH)
Measured: At 3 and 6 months after CVT diagnosis
Number of participants with symptomatic recurrent venous thromboembolism (VTE)
Number of participants who experience symptomatic recurrent venous thromboembolism (VTE), including cerebral venous thrombosis, deep vein thrombosis, pulmonary embolism, or splanchnic thrombosis.
Measured: At 3 and 6 months after CVT diagnosis
Number of participants who discontinued anticoagulant therapy early
Number of participants who discontinued DOAC therapy before the duration recommended by their treating physician, and documented reasons for discontinuation (e.g., adverse events, patient decision, or clinical judgment). Reasons will be collected from clinical records and follow-up interviews.
Measured: At 6 months after CVT diagnosis
Number of participants with arterial thrombotic events
Number of participants who experience arterial thrombotic events, including ischemic stroke, myocardial infarction, or other objectively confirmed arterial thromboses. Events will be confirmed by clinical assessment and/or imaging as appropriate.
Measured: At 6 months after CVT diagnosis
Health-related quality of life (EQ-5D-5L utility index score)
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument. This tool evaluates five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity.
A utility index score will be calculated using the Vietnamese EQ-5D-5L value set, ranging from -0.511 to 1.000, where:
1.000 indicates perfect health,
0.000 corresponds to death,
scores below 0 indicate health states considered worse than death by the general Vietnamese population.
Measured: At 3 and 6 months after CVT diagnosis
Serial D-dimer measurements after CVT
Plasma D-dimer levels will be measured at 3 and 6 months using a standardized quantitative assay. Values will be reported in ng/mL and interpreted in the context of post-CVT coagulation activity.
Measured: At 3 and 6 months after CVT diagnosis
Venous recanalization
Degree of venous sinus recanalization assessed on follow-up neuroimaging (MRI/MRV or CT/CTV) at 6 months. Recanalization will be categorized as complete, partial, or absent, based on standardized radiological criteria
Measured: At 6 months after CVT diagnosis
Frequency of chronic headache after CVT
Presence and frequency of persistent or recurrent headache fulfilling the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria for chronic post-CVT headache. Assessment will be based on patient-reported symptoms and clinical evaluation
Measured: At 6 months after CVT diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start11 Jul 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Cerebral Venous ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hieu Trung Dinh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hieu Trung Dinh, Bach Mai Hospital
- Investigators
- Ton D. Mai, Study chair, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083609
- Sponsor's protocol ID
- DOAC-CVT-VN2025-BMH
- Other IDs
- 45-BM-HDDD, 580-QD-DHYHN
- Acronym
- DCVT-VN25
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the single-center design, limited sample size, and institutional policies regarding patient confidentiality
Publications
Yang M, Rendas-Baum R, Varon SF, Kosinski M. Validation of the Headache Impact Test (HIT-6) across episodic and chronic migraine. Cephalalgia. 2011 Feb;31(3):357-67. doi: 10.1177/0333102410379890. Epub 2010 Sep 6.
PubMed 20819842Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
PubMed 29368949Aguiar de Sousa D, Lucas Neto L, Arauz A, Sousa AL, Gabriel D, Correia M, Gil-Gouveia R, Penas S, Carvalho Dias M, Correia MA, Carvalho M, Canhao P, Ferro JM. Early Recanalization in Patients With Cerebral Venous Thrombosis Treated With Anticoagulation. Stroke. 2020 Apr;51(4):1174-1181. doi: 10.1161/STROKEAHA.119.028532. Epub 2020 Mar 2.
PubMed 32114929Mai 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.
PubMed 32221805Kaatz 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.
PubMed 26764429Schulman 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.
PubMed 15842354Field TS, Lindsay MP, Wein T, Debicki DB, Gorman J, Heran MKS, Levin LA, Lund R, Moharir M, Peeling L, Perera KS, Siegal D, Verreault S, Foley N, Martin C, Smith EE, Mountain A, Mandzia J; Canadian Stroke Best Practice Recommendations Advisory Committee, in collaboration with the Canadian Stroke Consortium. Canadian Stroke Best Practice Recommendations, 7th Edition: Cerebral Venous Thrombosis, 2024. Can J Neurol Sci. 2024 Jun 3:1-17. doi: 10.1017/cjn.2024.269. Online ahead of print.
PubMed 38826076Ulivi L, Squitieri M, Cohen H, Cowley P, Werring DJ. Cerebral venous thrombosis: a practical guide. Pract Neurol. 2020 Oct;20(5):356-367. doi: 10.1136/practneurol-2019-002415.
PubMed 32958591Saposnik 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.
PubMed 38284265van 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.
PubMed 39986309Yaghi 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.
PubMed 35143325Field TS, Dizonno V, Almekhlafi MA, Bala F, Alhabli I, Wong H, Norena M, Villaluna MK, King-Azote P, Ratnaweera N, Mancini S, Van Gaal SC, Wilson LK, Graham BR, Sposato LA, Blacquiere D, Dewar BM, Boulos MI, Buck BH, Odier C, Perera KS, Pikula A, Tkach A, Medvedev G, Canfield C, Mortenson WB, Nadeau JO, Alshimemeri S, Benavente OR, Demchuk AM, Dowlatshahi D, Lanthier S, Lee AYY, Mandzia J, Suryanarayan D, Weitz JI, Hill MD; SECRET Investigators. Study of Rivaroxaban for Cerebral Venous Thrombosis: A Randomized Controlled Feasibility Trial Comparing Anticoagulation With Rivaroxaban to Standard-of-Care in Symptomatic Cerebral Venous Thrombosis. Stroke. 2023 Nov;54(11):2724-2736. doi: 10.1161/STROKEAHA.123.044113. Epub 2023 Sep 7.
PubMed 37675613Ma H, Gu Y, Bian T, Song H, Liu Z, Ji X, Duan J. Dabigatran etexilate versus warfarin in cerebral venous thrombosis in Chinese patients (CHOICE-CVT): An open-label, randomized controlled trial. Int J Stroke. 2024 Jul;19(6):635-644. doi: 10.1177/17474930241234749. Epub 2024 Feb 26.
PubMed 38353219Ferro JM, Coutinho JM, Dentali F, Kobayashi A, Alasheev A, Canhao P, Karpov D, Nagel S, Posthuma L, Roriz JM, Caria J, Frassdorf M, Huisman H, Reilly P, Diener HC; RE-SPECT CVT Study Group. Safety and Efficacy of Dabigatran Etexilate vs Dose-Adjusted Warfarin in Patients With Cerebral Venous Thrombosis: A Randomized Clinical Trial. JAMA Neurol. 2019 Dec 1;76(12):1457-1465. doi: 10.1001/jamaneurol.2019.2764.
PubMed 31479105Saposnik G, Barinagarrementeria F, Brown RD Jr, Bushnell CD, Cucchiara B, Cushman M, deVeber G, Ferro JM, Tsai FY; American Heart Association Stroke Council and the Council on Epidemiology and Prevention. Diagnosis and management of cerebral venous thrombosis: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2011 Apr;42(4):1158-92. doi: 10.1161/STR.0b013e31820a8364. Epub 2011 Feb 3.
PubMed 21293023
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis: A Prospective Observational Study in Vietnam
- ClinicalTrials.gov ID
- NCT07083609
- Acronym / sponsor ID
- DCVT-VN25 / DOAC-CVT-VN2025-BMH
- Conditions
- Cerebral Venous Thrombosis
- Keywords
- cerebral venous thrombosis, direct oral anticoagulants, rivaroxaban, dabigatran, major bleeding, recurrent VTE, modified Rankin Scale, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Hieu Trung DinhUniversity, hospital or other
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 the first 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.
Detailed description
Cerebral venous thrombosis (CVT) is an uncommon yet potentially life-threatening cerebrovascular condition. Direct oral anticoagulants (DOACs) are increasingly adopted for CVT management, supported by recent trials (e.g., RESPECT-CVT, CHOICE-CVT, SECRET) and observational cohorts. However, prospective real-world data, especially in low- and middle-income countries like Vietnam, remain scarce.
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 within the first 15 days. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DOAC Group | – | Drug: Dabigatran, Drug: RivaroxabanAdult 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) within the first 15 days after the start of heparin therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years old) with radiologically confirmed cerebral venous thrombosis (CVT) who received therapeutic-dose heparin during the acute phase and are subsequently treated with a direct oral anticoagulant. All participants will be recruited from Bach Mai Hospital, the national referral center in Vietnam that receives the majority of CVT cases in the northern region.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DabigatranAlso: PradaxaDabigatran will be initiated within the first 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. | Drug | DOAC Group |
| RivaroxabanAlso: XareltoRivaroxaban will be initiated within the first 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. | Drug | DOAC Group |
Primary outcome
Composite of major bleeding or recurrent venous thromboembolism
Time frame: Within 6 months after CVT diagnosis
A composite endpoint including: (1) the occurrence of VTE, defined as recurrent CVT, deep vein thrombosis of any limb, pulmonary embolism, or thrombosis involving the splanchnic, jugular, caval, renal, or catheter-related veins; and (2) major bleeding events, defined according to the criteria established by the International Society on Thrombosis and Haemostasis (ISTH)
11 secondary outcomes
Mortality Rate
Time frame: At 6 months after CVT diagnosis
Functional outcome
Time frame: At 3 and 6 months after after CVT diagnosis
Number of participants with major bleeding events
Time frame: At 3 and 6 months after CVT diagnosis
Number of participants with clinically relevant non-major bleeding (CRNMB) events
Time frame: At 3 and 6 months after CVT diagnosis
Number of participants with symptomatic recurrent venous thromboembolism (VTE)
Time frame: At 3 and 6 months after CVT diagnosis
Number of participants who discontinued anticoagulant therapy early
Time frame: At 6 months after CVT diagnosis
Number of participants with arterial thrombotic events
Time frame: At 6 months after CVT diagnosis
Health-related quality of life (EQ-5D-5L utility index score)
Time frame: At 3 and 6 months after CVT diagnosis
Serial D-dimer measurements after CVT
Time frame: At 3 and 6 months after CVT diagnosis
Venous recanalization
Time frame: At 6 months after CVT diagnosis
Frequency of chronic headache after CVT
Time frame: At 6 months after CVT diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 20819842Yang M, Rendas-Baum R, Varon SF, Kosinski M. Validation of the Headache Impact Test (HIT-6) across episodic and chronic migraine. Cephalalgia. 2011 Feb;31(3):357-67. doi: 10.1177/0333102410379890. Epub 2010 Sep 6.
- Background: PubMed 29368949Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
- Background: PubMed 32114929Aguiar de Sousa D, Lucas Neto L, Arauz A, Sousa AL, Gabriel D, Correia M, Gil-Gouveia R, Penas S, Carvalho Dias M, Correia MA, Carvalho M, Canhao P, Ferro JM. Early Recanalization in Patients With Cerebral Venous Thrombosis Treated With Anticoagulation. Stroke. 2020 Apr;51(4):1174-1181. doi: 10.1161/STROKEAHA.119.028532. Epub 2020 Mar 2.
- Background: PubMed 32221805Mai 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.
- Background: PubMed 26764429Kaatz 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.
- Background: PubMed 15842354Schulman 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.
- Background: PubMed 38826076Field TS, Lindsay MP, Wein T, Debicki DB, Gorman J, Heran MKS, Levin LA, Lund R, Moharir M, Peeling L, Perera KS, Siegal D, Verreault S, Foley N, Martin C, Smith EE, Mountain A, Mandzia J; Canadian Stroke Best Practice Recommendations Advisory Committee, in collaboration with the Canadian Stroke Consortium. Canadian Stroke Best Practice Recommendations, 7th Edition: Cerebral Venous Thrombosis, 2024. Can J Neurol Sci. 2024 Jun 3:1-17. doi: 10.1017/cjn.2024.269. Online ahead of print.
- Background: PubMed 32958591Ulivi L, Squitieri M, Cohen H, Cowley P, Werring DJ. Cerebral venous thrombosis: a practical guide. Pract Neurol. 2020 Oct;20(5):356-367. doi: 10.1136/practneurol-2019-002415.
- Background: PubMed 38284265Saposnik 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.
- Background: PubMed 39986309van 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.
- Background: PubMed 35143325Yaghi 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.
- Background: PubMed 37675613Field TS, Dizonno V, Almekhlafi MA, Bala F, Alhabli I, Wong H, Norena M, Villaluna MK, King-Azote P, Ratnaweera N, Mancini S, Van Gaal SC, Wilson LK, Graham BR, Sposato LA, Blacquiere D, Dewar BM, Boulos MI, Buck BH, Odier C, Perera KS, Pikula A, Tkach A, Medvedev G, Canfield C, Mortenson WB, Nadeau JO, Alshimemeri S, Benavente OR, Demchuk AM, Dowlatshahi D, Lanthier S, Lee AYY, Mandzia J, Suryanarayan D, Weitz JI, Hill MD; SECRET Investigators. Study of Rivaroxaban for Cerebral Venous Thrombosis: A Randomized Controlled Feasibility Trial Comparing Anticoagulation With Rivaroxaban to Standard-of-Care in Symptomatic Cerebral Venous Thrombosis. Stroke. 2023 Nov;54(11):2724-2736. doi: 10.1161/STROKEAHA.123.044113. Epub 2023 Sep 7.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the single-center design, limited sample size, and institutional policies regarding patient confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ton D. Mai study chair
Hanoi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Venous Thrombosis, run by Hieu Trung Dinh at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hieu T. Dinh, MD (+84982591092, dr.dinhhieu1092@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of major bleeding or recurrent venous thromboembolism (time frame: Within 6 months after CVT diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07083609, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.