[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599370":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":54,"studyPopulation":55,"armGroups":56,"interventions":63,"overallOfficials":77,"centralContacts":82,"locations":88,"responsibleParty":103,"collaborators":50,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":50,"enrollmentInfo":117,"targetDuration":50,"studyType":120,"phases":50,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":90,"whyStopped":50,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Bach Mai Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"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)","Within 6 months after CVT diagnosis",[14,18,22,26,29,32,35,38,41,44,47],{"measure":15,"description":16,"timeFrame":17},"Mortality Rate","All-cause mortality","At 6 months after CVT diagnosis",{"measure":19,"description":20,"timeFrame":21},"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.","At 3 and 6 months after after CVT diagnosis",{"measure":23,"description":24,"timeFrame":25},"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).","At 3 and 6 months after CVT diagnosis",{"measure":27,"description":28,"timeFrame":25},"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)",{"measure":30,"description":31,"timeFrame":25},"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.",{"measure":33,"description":34,"timeFrame":17},"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.",{"measure":36,"description":37,"timeFrame":17},"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\u002For imaging as appropriate.",{"measure":39,"description":40,"timeFrame":25},"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\u002Fdiscomfort, and anxiety\u002Fdepression), each with five levels of severity.\n\nA utility index score will be calculated using the Vietnamese EQ-5D-5L value set, ranging from -0.511 to 1.000, where:\n\n1.000 indicates perfect health,\n\n0.000 corresponds to death,\n\nscores below 0 indicate health states considered worse than death by the general Vietnamese population.",{"measure":42,"description":43,"timeFrame":25},"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\u002FmL and interpreted in the context of post-CVT coagulation activity.",{"measure":45,"description":46,"timeFrame":17},"Venous recanalization","Degree of venous sinus recanalization assessed on follow-up neuroimaging (MRI\u002FMRV or CT\u002FCTV) at 6 months. Recanalization will be categorized as complete, partial, or absent, based on standardized radiological criteria",{"measure":48,"description":49,"timeFrame":17},"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",null,{"allocation":50,"interventionModel":50,"interventionModelDescription":50,"primaryPurpose":50,"observationalModel":52,"timePerspective":53,"maskingInfo":50},"COHORT","PROSPECTIVE","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.\n\nThis 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.\n\nEligible 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:\n\nClinical outcomes\n\nD-dimer levels\n\nNeuroimaging for venous sinus recanalization\n\nFunctional status (Modified Rankin Scale)\n\nHealth-related quality of life (EQ-5D-5L)\n\nSafety outcomes including major bleeding, CRNMB, symptomatic recurrent VTE, arterial events, and chronic headache\n\nEarly treatment discontinuation and its causes (e.g., adverse events, patient decision)\n\nFindings from this study will contribute important real-world evidence to guide clinical practice, especially in Asian populations underrepresented in existing prospective research.","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.",[57],{"label":58,"type":50,"description":59,"interventionNames":60},"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",[61,62],"Drug: Dabigatran","Drug: Rivaroxaban",[64,71],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"DRUG","Dabigatran","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.",[58],[70],"Pradaxa",{"type":65,"name":72,"description":73,"armGroupLabels":74,"otherNames":75},"Rivaroxaban","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.",[58],[76],"Xarelto",[78],{"name":79,"affiliation":80,"role":81},"Ton D. Mai","Hanoi Medical University","STUDY_CHAIR",[83],{"name":84,"role":85,"phone":86,"phoneExt":50,"email":87},"Hieu T. Dinh, MD","CONTACT","+84982591092","dr.dinhhieu1092@gmail.com",[89],{"facility":5,"status":90,"city":91,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"RECRUITING","Hanoi","100000","Vietnam","VN",{"type":96,"coordinates":97},"Point",[98,99],105.84117,21.0245,{"lat":99,"lon":98},[102],{"name":84,"role":85,"phone":86,"phoneExt":50,"email":87},{"type":104,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"SPONSOR_INVESTIGATOR","Hieu Trung Dinh","Principal Investigator","100599370","treatment-outcomes-of-direct-oral-anticoagulants-in-cerebral-venous-thrombosis-in-vietnam-100599370",false,"NCT07083609","Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis in Vietnam","Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis: A Prospective Observational Study in Vietnam","DCVT-VN25","Inclusion Criteria:\n\n* Signed informed consent (ICF) to participate in the study\n* Age ≥ 18 years\n* Confirmed diagnosis of cerebral venous thrombosis (CVT) based on clinical presentation and neuroimaging, including one or more of the following:\n\nMRI and MRV, AND\u002FOR CT and CTV, AND\u002FOR MRI or CT combined with DSA\n\n* Initiation of DOACs within the first 15 days after starting treatment with heparin\n\nExclusion Criteria:\n\n* CVT accompanied by antiphospholipid syndrome with all three positive laboratory criteria: lupus anticoagulant, anticardiolipin antibodies, and anti-β2-glycoprotein antibodies\n* CVT in pregnant patients requiring continuous anticoagulation throughout pregnancy\n* CVT with coexisting bleeding disorders, including immune thrombocytopenia with platelet count \\\u003C100,000\u002FmL, hemophilia A or B, von Willebrand disease, or a history of prolonged bleeding after surgery or invasive procedures\n* CVT in patients with mechanical heart valves, atrial fibrillation, and moderate to severe mitral stenosis\n* CVT in patients with a glomerular filtration rate (GFR) \\\u003C15 mL\u002Fmin\n* CVT with severe hepatic impairment\n* Patients already receiving anticoagulation therapy for another underlying condition at the time of CVT diagnosis","ALL","18 Years",{"count":118,"type":119},69,"ESTIMATED","OBSERVATIONAL","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.\n\nA 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.\n\nThe primary outcome is a composite of major bleeding (per ISTH criteria) or recurrent venous thromboembolism (VTE) within 6 months.\n\nSecondary 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.\n\nThis study aims to generate real-world data supporting DOAC use in CVT, particularly in Asian populations where prospective evidence is limited.",[123],"Cerebral Venous Thrombosis",[125,126,127,128,129,130,131,132,133,134],"cerebral venous thrombosis","direct oral anticoagulants","rivaroxaban","dabigatran","major bleeding","recurrent VTE","modified Rankin Scale","quality of life","prospective cohort","observational study","2026-10-06",{"date":137,"type":138},"2026-10-09","ACTUAL",{"date":140,"type":138},"2025-07-11",{"date":142,"type":119},"2027-12",{"name":105,"class":6},1]