[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561793":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":28,"locations":39,"responsibleParty":58,"collaborators":24,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":24,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Carvedilol plus endoscopic variceal ligation","ACTIVE_COMPARATOR","Take carvedilol every day (start from 6.25 mg\u002Fd and then titrate to 12.5 mg\u002Fd if tolerable) and undergo EVL every 3-4 weeks until variceal eradication followed by regular endoscopic follow-up according to the protocol.",[13],"Other: Carvedilol plus endoscopic variceal ligation",{"label":15,"type":16,"description":17,"interventionNames":18},"Carvedilol alone","PLACEBO_COMPARATOR","Take carvedilol alone every day (start from 6.25 mg\u002Fd and then titrate to 12.5 mg\u002Fd if tolerable).",[19],"Drug: Carvedilol alone",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"OTHER",[9],null,{"type":26,"name":15,"description":17,"armGroupLabels":27,"otherNames":24},"DRUG",[15],[29,35],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Tsung-Chieh Yang, MD","CONTACT","886-2-28712121","7506","tcyang@vghtpe.gov.tw",{"name":36,"role":31,"phone":32,"phoneExt":37,"email":38},"Ming-Chih Hou, MD","7053","mchou@vghtpe.gov.tw",[40],{"facility":41,"status":42,"city":43,"state":24,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Taipei Veterans General Hospital","RECRUITING","Taipei","11217","Taiwan","TW",{"type":48,"coordinates":49},"Point",[50,51],121.52639,25.05306,{"lat":51,"lon":50},[54,55,56],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},{"name":36,"role":31,"phone":32,"phoneExt":37,"email":38},{"name":30,"role":57,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"type":59,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100561793","phase-4-carvedilol-plus-evl-or-not-for-the-primary-prevention-of-esophageal-variceal-bleeding-in-carvedilol-non-responders-100561793",false,"NCT06594783","Carvedilol Plus EVL or Not for the Primary Prevention of Esophageal Variceal Bleeding in Carvedilol Non-responders","Carvedilol Plus Endoscopic Ligation or Not for the Primary Prevention of Esophageal Variceal Bleeding in Carvedilol Non-responders: a Randomized Controlled Trial","CVL-NR","Inclusion Criteria:\n\n\\- Cirrhotic patients with esophageal varices who, after carvedilol treatment, continue to experience variceal enlargement or develop new red color signs.\n\nExclusion Criteria:\n\n* Age under 18 or over 90 years.\n* History of esophageal variceal bleeding.\n* Previous treatment for esophageal varices, including endoscopic variceal ligation, endoscopic sclerotherapy, transjugular intrahepatic portosystemic shunt, or surgery.\n* Contraindications to non-selective beta-blockers, including severe atrioventricular block, chronic obstructive pulmonary disease (COPD), asthma, uncontrolled diabetes mellitus, or severe peripheral artery disease.\n* Presence of end-stage organ diseases, including hepatocellular carcinoma or other terminal cancers, heart failure, or renal failure.\n* Pregnant women.\n* Refusal to participate in the study.","ALL","18 Years","90 Years",{"count":72,"type":73},80,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","The goal of this clinical trial is to evaluate whether carvedilol plus endoscopic variceal ligation (EVL) is more effective for the primary prevention of esophageal variceal bleeding than carvedilol alone in carvedilol non-responders. It will also learn about the safety of carvedilol combined with EVL in patients with cirrhosis.\n\nThe main questions it aims to answer are:\n\nWhether carvedilol plus EVL is more effective than carvedilol alone in preventing the first esophageal variceal bleeding in cirrhotic patients unresponsive to carvedilol.\n\nWhat medical problems do participants have when taking carvedilol or taking carvedilol combined with undergoing EVL? Researchers will compare the efficacy and safety of carvedilol with or without EVL in preventing the first esophageal variceal bleeding in cirrhotic patients unresponsive to carvedilol.\n\nParticipants will:\n\nTake carvedilol every day (start from 6.25 mg\u002Fd and then titrate to 12.5 mg\u002Fd if tolerable) and undergo EVL every 3-4 weeks until variceal eradication followed by regular endoscopic follow-up according to the protocol, or Take carvedilol alone every day (start from 6.25 mg\u002Fd and then titrate to 12.5 mg\u002Fd if tolerable).\n\nVisit the clinic once every 2-3 months for checkups and tests. Keep a diary of their vital signs (SBP, DBP, and HR) as well as symptoms.",[79,80],"Cirrhosis","Esophageal Varices",[79,82,83,84],"Endoscopic variceal ligation","Nonselective beta-blocker","Portal hypertension","2025-02-10",{"date":87,"type":88},"2025-02-11","ACTUAL",{"date":90,"type":88},"2025-01-06",{"date":92,"type":73},"2030-10",{"name":5,"class":6},1]