[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cerebral-venous-thrombosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cerebral-venous-thrombosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,75,102,130],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100620033","phase-4-randomized-trial-of-anticoagulation-plus-batroxobin-for-acute-cerebral-venous-thrombosis-100620033",false,"NCT07352358","Randomized Trial of Anticoagulation Plus Batroxobin for Acute Cerebral Venous Thrombosis","Randomized Trial of Anticoagulation Plus Batroxobin for Acute Cerebral Venous Thrombosis (ABACVT)","ABACVT","Inclusion Criteria:\n\n1. Aged ≥18 years;\n2. Neuroimaging confirmed acute CVT;\n3. Symptoms onset was within 30 days prior to enrollment;\n4. Signed the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with bleeding (including those with bleeding disorders due to coagulation and vascular disorders, active peptic ulcers, suspected intracranial hemorrhage, thrombocytopenic purpura, hemophilia, during menstruation, during surgery, urinary tract bleeding, hemoptysis, premature delivery, miscarriage, women immediately after delivery and during the puerperium with bleeding from the sexual organs, etc.);\n2. Recently operated patients\n3. Patients with a potential for bleeding (such as those with visceral tumors, diverticulitis of the digestive tract, colitis, subacute bacterial endocarditis, severe hypertension, and severe diabetes, etc.);\n4. Those who are currently taking anticoagulant drugs and platelet function inhibitors (such as aspirin) and those who are using antifibrinolytic agents;\n5. Those with a pre-medication fibrinogen concentration lower than 100 mg\u002Fdl;\n6. Patients with severe liver or kidney dysfunction and other conditions such as papillary muscle rupture, ventricular septal perforation, cardiogenic shock, and multiple organ failure.\n7. Those who have a history of allergy to this preparation.","ALL","18 Years","80 Years",{"count":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","A total of 72 patients meeting the diagnostic criteria for acute cerebral venous thrombosis were included in this study. A multi-center stratified randomization method was adopted, with the stratification factor being each participating center. There were three groups in total, and within each group, the experimental group and the control group were assigned in a 1:1 ratio. Finally, all the experimental groups and control groups were combined to form the overall experimental group and control group. Random sequences were generated using a computer random number generator, and concealed allocation was implemented using sealed, opaque, consecutively numbered envelopes. Patients and their families, researchers, treating physicians and nurses, outcome assessors, and other personnel directly involved in the trial were unaware of the treatment allocation. Patients meeting the inclusion criteria for acute CVT were immediately given standard anticoagulant therapy (subcutaneous injection of low-molecular-weight heparin at a dose of 0.4 mg every 12 hours for 5-7 days). Subsequently, patients were randomly assigned to the experimental group and the control group. The experimental group received a combination of anticoagulants (low-molecular-weight heparin bridged to warfarin 3 mg\u002Fday, rivaroxaban 10-20 mg\u002Fday, or dabigatran 110-150 mg twice daily) and batroxobin (initial dose of 10 BU, followed by 5 BU every other day); the control group received only the aforementioned anticoagulants. Follow-up evaluations were conducted at 7 days, 30 days, and 90 days after baseline. Baseline data included demographic characteristics, routine laboratory tests (complete blood count, liver and kidney function tests, electrolyte analysis, urine analysis, and coagulation function), TOF MRV, NIHSS score, and mRS score. Follow-up data covered TOF MRV, NIHSS score, and mRS score at 7 days, 30 ± 7 days, and 90 ± 7 days for the treatment groups. NIHSS and mRS assessments were conducted by neurologists who were unaware of the treatment plan. To minimize potential bias in the primary outcome, qualified personnel at each research center reviewed the 90-day clinical evaluations according to a standardized procedure manual. To ensure the validity and reproducibility of the evaluations, training courses were held for all researchers at each center. In addition, researchers recorded in detail the concomitant medications and adverse events that occurred within 90 days after patient enrollment. The primary endpoint was the proportion of patients achieving recanalization within 7 days of treatment. Secondary endpoints included the proportion of patients achieving neurological improvement (NIHSS score reduction ≥ 2 points) or deterioration (NIHSS score increase ≥ 4 points) at 7 days, 30 days, and 90 days, the proportion of patients achieving functional improvement (mRS score reduction) within 90 days, and the occurrence of CVT recurrence or other vascular events within 90 days.",[28],"Cerebral Venous Thrombosis","RECRUITING","2026-01-11",{"date":32,"type":33},"2026-01-20","ACTUAL",{"date":35,"type":22},"2026-01-30",{"date":37,"type":22},"2028-07-01",{"name":39,"class":40},"Xuanwu Hospital, Beijing","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":41},"100599370","treatment-outcomes-of-direct-oral-anticoagulants-in-cerebral-venous-thrombosis-in-vietnam-100599370","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",{"count":51,"type":22},69,"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.",[28],[56,57,58,59,60,61,62,63,64,65],"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":68,"type":33},"2025-07-24",{"date":70,"type":33},"2025-07-11",{"date":72,"type":22},"2027-12",{"name":74,"class":40},"Hieu Trung Dinh",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":82,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":41},"100588922","safety-and-efficacy-of-edoxaban-and-rivaroxaban-to-cerebral-venous-thrombosis-in-chinese-patients-100588922","NCT06947707","Safety and Efficacy of Edoxaban and Rivaroxaban to Cerebral Venous Thrombosis in Chinese Patients","Safety and Efficacy of Edoxaban and Rivaroxaban to Cerebral Venous Thrombosis in Chinese Patients: A Prospective Cohort Study","Inclusion Criteria:\n\n1. Patient aged from 18 to 80 years and no gender preference;\n2. Diagnosis of CVT as confirmed on MRBTI\u002FMRV or CT\u002FCTV or DSA;\n3. Acute or subacute CVT from onset to door within 4 weeks;\n4. The treating clinician irrelevant to the study is of the opinion that the patient is appropriate for edoxaban or rivaroxaban;\n5. Patient or legally authorized representative is able to give written informed consent.\n\nExclusion Criteria:\n\n1. Patient refuse to take edoxaban or rivaroxaban to treat CVT;\n2. Pregnancy or breastfeeding women at the time of enrollment, or women who plan to get pregnant during study;\n3. Patient is anticipated to require invasive procedure (e.g. thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation;\n4. CVT secondary to central nervous system infection or severe head trauma;\n5. It is in the proliferative stage of malignant tumors currently or within 6 months of diagnosis;\n6. Bleeding diathesis or other contraindication to anticoagulation;\n7. Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use;\n8. Concomitant use of strong CYP3A4 or P-gp inhibitors;\n9. Impaired renal function (CrCl\\\u003C30 mL\u002Fmin using Cockcroft-Gault equation) or investigator anticipate the CrCl lower than 30 mL\u002Fmin during study;\n10. Impaired liver function (ALT or AST exceeds twice the normal upper limit) or diagnosed as acute hepatitis currently;\n11. Patient is unable to swallow due to depressed level of consciousness or other reasons;\n12. Patient has a severe or fatal comorbid illness with life expectancy less than 6 months;\n13. Patient with severe hypertension (SBP≥180mmHg and\u002For DBP≥110mmHg);\n14. Patient is known to be allergic to edoxaban or rivaroxaban.",{"count":83,"type":22},1486,"The goal of this observational study is to learn the safety and efficacy of edoxaban and rivaroxaban in Chinese population with the age range from 18 to 80 years who take edoxaban or rivaroxaban to treat their cerebral venous thrombosis (CVT). The main question it aims to answer are:\n\n* Do cerebral veins or venous sinuses recanalize during the treatment period of edoxaban and rivaroxaban?\n* Do the bleeding events occur during the treatment period of edoxaban and rivaroxaban?\n\nThe main tasks participants will be asked to do:\n\n* Participants will comply fully with the prescribed regimen and take the edoxaban or rivaroxaban as directed at the specified dosage.\n* Participants will return to hospital for scheduled follow-up assessments at months 3, 6, 9, and 12 post-enrollment to undergo face-to-face visits with investigators.",[28,86,87,88,89,90,91,92,93],"Anticoagulants and Thrombotic Disorders","Anticoagulation Treatment","Anticoagulant Therapy","Anticoagulant Drugs","NOACs","Anticoagulant Prophylaxis\u002FTherapy","Anticoagulation With NOAC","Anticoagulation With Direct Oral Anticoagulants","2025-04-20",{"date":96,"type":33},"2025-04-27",{"date":98,"type":33},"2025-04-10",{"date":100,"type":22},"2027-12-31",{"name":39,"class":40},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":41},"100556900","phase-3-rivaroxaban-versus-apixaban-in-cerebral-venous-thrombosis-100556900","NCT06531122","Rivaroxaban Versus Apixaban in Cerebral Venous Thrombosis","Rivaroxaban Versus Apixaban in Cerebral Venous Thrombosis, a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Patients aged 18 and above\n2. New diagnosis of symptomatic cerebral venous thrombosis as confirmed on CT\u002FCT venogram or MRI\u002FMR venogram\n3. Ability to randomize within 14 days of neuroimaging-confirmed diagnosis\n4. The treating clinician is of the opinion that the patient is appropriate for oral anticoagulation as per the standard of care\n5. The patient or legally authorized representative is able to give written informed consent\n\nExclusion Criteria:\n\n1. The patient has known antiphospholipid antibody syndrome with a previous history of venous or arterial thrombosis\n2. The patient is anticipated to require invasive procedures (e.g., lumbar puncture, thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation\n3. Patient is unable to swallow due to depressed level of consciousness\n4. Impaired renal function (i.e., CrCl \\\u003C 30 mL\u002Fmin using CockroftGault equation)\n5. Pregnancy; if a woman is of childbearing potential a urine or serum beta human chorionic gonadotropin (β-hCG) test is positive\n6. Breastfeeding at the time of randomization\n7. Bleeding diathesis or other contraindication to anticoagulation\n8. Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use\n9. Concomitant use of strong CYP3A4 inducers (e.g., ongoing use of dilantin, carbamazepine, HIV protease inhibitors) or CYP3A4 inhibitors (e.g., diltiazem, ketoconazole)\n10. Patient has a severe or fatal comorbid illness that will prevent improvement","75 Years",{"count":111,"type":22},200,[113],"PHASE3","Along with the current clinical trial, the efficacy and safety of a 20 mg rivaroxaban administered within 24 hours of randomization after having first-ever cerebral venous thrombosis compared to apixaban 5mg Bid were assessed through rate of recurrent VTE, mRS, rate of venous recanalization, HIT score, MoCA test, and central and peripheral heamoragic complications.",[28],[117,118,28,119,120],"apixaban,","rivaroxiban","Egypt","Middle east","2024-08-16",{"date":123,"type":33},"2024-08-19",{"date":125,"type":33},"2021-08-01",{"date":127,"type":22},"2024-09-20",{"name":129,"class":40},"Kafrelsheikh University",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":140,"conditions":141,"keywords":142,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":41},"100413220","direct-oral-anticoagulants-for-the-treatment-of-cerebral-venous-thrombosis-100413220","NCT04660747","Direct Oral Anticoagulants for the Treatment of Cerebral Venous Thrombosis","Direct Oral Anticoagulants for the Treatment of Cerebral Venous Thrombosis: An International Phase IV Study","DOAC-CVT","Inclusion Criteria:\n\n* Written informed consent for the use of observational data\n* Age \\>18 years at the time of CVT diagnosis\n* Radiologically confirmed CVT diagnosis (CT-venography, MRI or catheter angiography)\n* Oral anticoagulant treatment (DOAC or VKA) started within 30 days of CVT diagnosis (patient may initially be treated with heparin)\n* Inclusion in the study within 90 days of CVT diagnosis\n\nExclusion Criteria:\n\n* Anticoagulant treatment at the time of CVT diagnosis\n* Pregnancy or lactation (post-partum women are eligible if they do not give breast-feeding)\n* Mechanical heart valve\n* Severe renal insufficiency (defined as an eGFR \\\u003C15 ml\u002Fmin)\n* Severe liver disease resulting in clinically relevant coagulopathy",{"count":139,"type":22},1300,"Rationale: Patients with cerebral venous thrombosis (CVT) are currently treated with anticoagulants during 3-12 months after diagnosis, to prevent worsening of the CVT and recurrent thrombosis, and to promote venous recanalization. Until recently, patients were generally treated with vitamin K antagonists (VKA). Direct oral anticoagulants (DOACs) are more practical in use than VKA and carry a lower risk of intracranial hemorrhage (ICH) in other conditions. One of the burning clinical questions is whether CVT patients can be safely treated with DOACs instead of VKA. In 2019, the first randomized trial on the safety and efficacy of DOACs in CVT was published (RESPECT-CVT). This exploratory study included 120 patients and the results suggest that DOACs can be safely used to treat CVT. Following RESPECT-CVT, use of DOACs to treat CVT is expected to rise, but given the limited sample size and strict selection criteria of RESPECT-CVT, additional data regarding the efficacy and safety of DOACs in CVT are required, especially from routine clinical care.\n\nObjective: To assess the safety and efficacy of DOACs for the treatment of CVT in a real-world setting.\n\nStudy design: DOAC-CVT is an international, prospective, comparative cohort study. Initially, DOAC-CVT was designed to recruit 500 patients in a three-year study period. All patients recruited until January 15, 2024 will be included in the primary data analysis as previously described (https:\u002F\u002Fdoi.org\u002F10.3389\u002Ffneur.2023.1251581). In addition, we will continue patient recruitment in an extension of the study until January 2026 to have a larger sample size, add new research questions, and to further strengthen global. We aim to recruit 1300 patients and anticipating a 3:2 ratio in DOAC:VKA use, we expect that in total 780 patients treated with a DOAC will be included.\n\nStudy population: Patients are eligible if they are \\>18 years old, have a radiologically confirmed CVT, have started oral anticoagulant treatment (DOAC or VKA) within 30 days of CVT diagnosis, and are included in the study within 90 days after CVT diagnosis.\n\nPrimary study endpoint: The primary endpoint is a composite of major bleeding (according to the criteria of the International Society on Thrombosis and Haemostasis) AND symptomatic recurrent venous thrombosis after 6 months of follow-up.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: This is an observational study which poses no risk or burden to the participant. Only data that are collected as part of routine clinical care will be used.",[28],[28,143,144,145,146],"Cerebral Venous Sinus Thrombosis","Oral Anticoagulants","Direct Oral Anticoagulants","Vitamin K Antagonists","2024-08-15",{"date":123,"type":33},{"date":150,"type":33},"2021-01-27",{"date":152,"type":22},"2028-01",{"name":154,"class":40},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)"]