[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599370":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":55,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":10,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Bach Mai Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"DOAC Group",null,"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",[13,14],"Drug: Dabigatran","Drug: Rivaroxaban",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","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.",[9],[22],"Pradaxa",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"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.",[9],[28],"Xarelto",[30],{"name":31,"affiliation":32,"role":33},"Ton D. Mai","Hanoi Medical University","STUDY_CHAIR",[35],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Hieu T. Dinh, MD","CONTACT","+84982591092","dr.dinhhieu1092@gmail.com",[41],{"facility":5,"status":42,"city":43,"state":10,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Hanoi","100000","Vietnam","VN",{"type":48,"coordinates":49},"Point",[50,51],105.84117,21.0245,{"lat":51,"lon":50},[54],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"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 5 to 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":70,"type":71},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 5 to 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.",[75],"Cerebral Venous Thrombosis",[77,78,79,80,81,82,83,84,85,86],"cerebral venous thrombosis","direct oral anticoagulants","rivaroxaban","dabigatran","major bleeding","recurrent VTE","modified Rankin Scale","quality of life","prospective cohort","observational study","2025-07-21",{"date":89,"type":90},"2025-07-24","ACTUAL",{"date":92,"type":90},"2025-07-11",{"date":94,"type":71},"2027-12",{"name":57,"class":6},1]