[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578975":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":53,"collaborators":24,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":24,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":24,"studyType":68,"phases":69,"briefSummary":72,"conditions":73,"keywords":24,"overallStatus":76,"whyStopped":24,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Institute of Liver and Biliary Sciences, India","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Enoxaparin","ACTIVE_COMPARATOR","Enoxaparin Treatment would be given with 1 mg \u002FKg (100IU\u002FKg) dose s\u002Fc twice daily for 6 months.",[13],"Drug: Enoxaparin",{"label":15,"type":16,"description":17,"interventionNames":18},"Dabigatran","EXPERIMENTAL","Dabigatran 150 mg BD fixed dose to be given for duration of 6 months.",[19],"Drug: Dabigatran",[21,25],{"type":22,"name":15,"description":17,"armGroupLabels":23,"otherNames":24},"DRUG",[15],null,{"type":22,"name":9,"description":26,"armGroupLabels":27,"otherNames":24},"Enoxaparin . Treatment would be given with 1 mg \u002FKg (100IU\u002FKg) dose s\u002Fc twice daily for 6 months.",[9],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Dr Sarthak Chanana, MD","CONTACT","01146300000","xs2sarthak@gmail.com",{"name":35,"role":31,"phone":32,"phoneExt":24,"email":36},"Dr Rajan V, DM","rajanvf40@gmail.com",[38],{"facility":39,"status":24,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Institute of Liver & Biliary Sciences (ILBS)","New Delhi","National Capital Territory of Delhi","110070","India","IN",{"type":46,"coordinates":47},"Point",[48,49],77.2148,28.62137,{"lat":49,"lon":48},[52],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},{"type":54,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100578975","phase-2-compare-the-efficacy-and-safety-of-dabigatran-and-enoxaparin-in-patients-with-portal-vein-thrombosis-with-cirrhosis-100578975",false,"NCT06818279","Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis","Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis: A Randomized Controlled Study","Inclusion Criteria:\n\n1. Age \\>18 years\n2. Cirrhosis with portal vein thrombosis within 6 months of diagnosis\u002FSymptomatic PVT\u002FPVT in potential transplant recipient.\n\nExclusion Criteria:\n\n1. Contraindications to anticoagulant therapy, such as active bleeding, recent major surgery, or known hypersensitivity to study medications.\n2. CTP \\>10\n3. Hepatocellular carcinoma\n4. Tumoral PVT\n5. Isolated gastric varices with red colour signs\n6. Peptic ulcer disease with large ulcers\n7. Pregnant or breastfeeding women\n8. Thrombocytopenia (platelet count \\\u003C50,000\u002FμL)\n9. Patients with concurrent acute kidney injury or chronic kidney disease stage 4 or 5\n10. Those not giving consent for therapy","ALL","18 Years","70 Years",{"count":66,"type":67},120,"ESTIMATED","INTERVENTIONAL",[70,71],"PHASE2","PHASE3","Portal vein thrombosis (PVT) is prevalent among patients with cirrhosis, and its prevalence rises with the severity of liver disease. Numerous studies have indicated that patients developing PVT experience elevated portal pressure and associated complications, such as increased incidence of variceal bleeding, higher rates of failed variceal bleed control, rebleeding, and short-term mortality. Additionally, the development of PVT adversely affects post-transplant outcomes, correlating with increased 30-day mortality among transplant recipients with PVT. Current guidelines lack clarity regarding the optimal choice of anticoagulation therapy for patients with cirrhosis. This study aims to evaluate the efficacy and safety of enoxaparin and dabigatran in achieving complete recanalization of portal vein thrombosis in cirrhotic patients over a 6-month period.",[74,75],"Portal Vein Thrombosis","Liver Cirrhosis","NOT_YET_RECRUITING","2025-02-04",{"date":79,"type":80},"2025-02-10","ACTUAL",{"date":82,"type":67},"2025-01-31",{"date":84,"type":67},"2026-01-31",{"name":5,"class":6},1]