[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658505":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":52,"studyPopulation":41,"armGroups":53,"interventions":65,"overallOfficials":75,"centralContacts":79,"locations":85,"responsibleParty":227,"collaborators":229,"id":246,"slug":247,"hasResults":248,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":248,"sex":254,"minAge":255,"maxAge":41,"enrollmentInfo":256,"targetDuration":41,"studyType":259,"phases":260,"briefSummary":262,"conditions":263,"keywords":266,"overallStatus":274,"whyStopped":41,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":284},{"fullName":5,"class":6},"Samsung Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Net Adverse Clinical Events (NACE)","Time to the first occurrence of a net adverse clinical event, defined as a composite of recurrent venous thromboembolism, venous thromboembolism-related death, or major bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) criteria.","From randomization until 1 year after enrollment of the last participant",[14,17,20,23,26,29,32,35,38],{"measure":15,"description":16,"timeFrame":12},"Recurrent Venous Thromboembolism or Venous Thromboembolism-related Death","Time to the first occurrence of recurrent venous thromboembolism or venous thromboembolism-related death.",{"measure":18,"description":19,"timeFrame":12},"Recurrent Venous Thromboembolism","Time to the first occurrence of objectively confirmed recurrent venous thromboembolism, including recurrent deep vein thrombosis or recurrent pulmonary embolism.",{"measure":21,"description":22,"timeFrame":12},"Venous Thromboembolism-related Death","Death resulting from objectively confirmed fatal pulmonary embolism, recurrent venous thromboembolism directly leading to death, or unexplained death for which no alternative cause is identified and which is adjudicated as venous thromboembolism-related by the Clinical Event Adjudication Committee.",{"measure":24,"description":25,"timeFrame":12},"Major Bleeding According to International Society on Thrombosis and Haemostasis Criteria","Time to the first occurrence of major bleeding according to International Society on Thrombosis and Haemostasis criteria, including fatal bleeding, symptomatic bleeding in a critical area or organ, bleeding causing a decrease in hemoglobin of at least 2 g\u002FdL, or bleeding requiring transfusion of at least 2 units of whole blood or packed red blood cells.",{"measure":27,"description":28,"timeFrame":12},"Clinically Relevant Non-major Bleeding","Time to the first occurrence of clinically relevant non-major bleeding, defined as clinically overt bleeding that does not meet the criteria for major bleeding but leads to hospitalization or an increased level of care, medical or surgical treatment, or a change in antithrombotic therapy.",{"measure":30,"description":31,"timeFrame":12},"Clinically Relevant Bleeding","Time to the first occurrence of clinically relevant bleeding, defined as a composite of major bleeding or clinically relevant non-major bleeding.",{"measure":33,"description":34,"timeFrame":12},"Broad Net Adverse Clinical Events","Time to the first occurrence of a broad net adverse clinical event, defined as a composite of recurrent venous thromboembolism, venous thromboembolism-related death, major bleeding, or clinically relevant non-major bleeding.",{"measure":36,"description":37,"timeFrame":12},"All-cause Mortality","Death due to any cause occurring during the study follow-up period.",{"measure":39,"description":40,"timeFrame":12},"Permanent Discontinuation Due to Adverse Events","Permanent discontinuation of the assigned study drug due to any adverse event during follow-up.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":45,"primaryPurpose":46,"observationalModel":41,"timePerspective":41,"maskingInfo":47},"RANDOMIZED","PARALLEL","prospective, multicenter, randomized, open label, blinded-endpoint trial","TREATMENT",{"masking":48,"maskingDescription":49,"whoMasked":50},"SINGLE","The study uses a prospective randomized open-label, blinded-endpoint (PROBE) design. Participants and treating investigators are aware of treatment assignment, while clinical events corresponding to the study endpoints are adjudicated by an independent Clinical Event Adjudication Committee blinded to treatment allocation.",[51],"OUTCOMES_ASSESSOR","Cancer-associated thrombosis (CAT) is an important cause of morbidity and mortality in patients with active cancer. Patients with CAT are at increased risk of both recurrent venous thromboembolism and bleeding during anticoagulant treatment, making the balance between efficacy and safety particularly important when selecting an anticoagulant.\n\nNon-vitamin K antagonist oral anticoagulants have become established treatment options for CAT. Edoxaban and apixaban are both factor Xa inhibitors with demonstrated efficacy and safety in patients with CAT. However, they have been evaluated separately against low-molecular-weight heparin, and direct randomized comparisons between edoxaban and apixaban are lacking. The two agents also differ in dosing frequency, dose-reduction strategies, pharmacokinetic characteristics, and renal elimination. Whether these differences translate into differences in overall clinical outcomes in patients with CAT remains uncertain.\n\nNEXT-CAT is a prospective, multicenter, randomized, open-label, blinded-endpoint trial designed to directly compare edoxaban-based treatment with apixaban-based treatment in patients with active cancer and objectively confirmed venous thromboembolism. A total of 2,300 participants will be randomized in a 1:1 ratio, with randomization stratified by participating center and the presence of gastrointestinal cancer at baseline.\n\nThe primary hypothesis is that edoxaban-based treatment is non-inferior to apixaban-based treatment with respect to the incidence of net adverse clinical events (NACE). The primary endpoint is a composite of recurrent venous thromboembolism, venous thromboembolism-related death, or major bleeding according to the International Society on Thrombosis and Haemostasis criteria. Participants will be followed at 1, 3, 6, 9, 12, and 18 months after randomization and annually thereafter, with follow-up continuing until 1 year after enrollment of the last participant.\n\nClinical events corresponding to the primary and secondary endpoints will be evaluated by an independent Clinical Event Adjudication Committee blinded to treatment allocation.",[54,60],{"label":55,"type":56,"description":57,"interventionNames":58},"Edoxaban-based Treatment","ACTIVE_COMPARATOR","Participants randomized to this arm will receive oral edoxaban once daily. The standard dose is 60 mg once daily, with dose reduction according to the protocol based on renal function, body weight, concomitant P-glycoprotein inhibitors, and other prespecified clinical factors.",[59],"Drug: edoxaban",{"label":61,"type":56,"description":62,"interventionNames":63},"Apixaban-based Treatment","Participants randomized to this arm will receive oral apixaban twice daily. The standard dose is 5 mg twice daily, with dose reduction to 2.5 mg twice daily according to the prespecified dose-reduction criteria in the protocol.",[64],"Drug: Apixaban",[66,71],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":41},"DRUG","edoxaban","Edoxaban is administered orally once daily. The standard dose is 60 mg once daily. The dose is reduced to 30 mg once daily in participants with a creatinine clearance of 15-50 mL\u002Fmin, body weight ≤60 kg, or concomitant use of specified P-glycoprotein inhibitors. In participants aged ≥80 years who are considered at high risk of bleeding and meet the prespecified criteria, further dose reduction to 15 mg once daily may be considered.",[55],{"type":67,"name":72,"description":73,"armGroupLabels":74,"otherNames":41},"Apixaban","Apixaban is administered orally at a standard dose of 5 mg twice daily. The dose is reduced to 2.5 mg twice daily in participants who meet the prespecified dose-reduction criteria, including those who meet at least two of the following criteria: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg\u002FdL, or those with severe renal impairment with a creatinine clearance of 15-29 mL\u002Fmin.",[61],[76],{"name":77,"affiliation":5,"role":78},"Eun Kyoung Kim","PRINCIPAL_INVESTIGATOR",[80],{"name":81,"role":82,"phone":83,"phoneExt":41,"email":84},"Yunjeong Song, RN","CONTACT","82-2-3410-2171","yjung.song@sbri.co.kr",[86,101,114,126,138,150,163,175,184,193,208,217],{"facility":87,"status":41,"city":88,"state":89,"zip":41,"country":90,"countryCode":41,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"National Cancer Center","Goyang-si","Gyeonggi-do","South Korea",{"type":92,"coordinates":93},"Point",[94,95],126.835,37.65639,{"lat":95,"lon":94},[98,100],{"name":99,"role":82,"phone":41,"phoneExt":41,"email":41},"Mi-Hyang Kwak",{"name":99,"role":78,"phone":41,"phoneExt":41,"email":41},{"facility":102,"status":41,"city":103,"state":41,"zip":41,"country":90,"countryCode":41,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Dong-A University Hospital","Busan",{"type":92,"coordinates":105},[106,107],129.03004,35.10168,{"lat":107,"lon":106},[110,112],{"name":111,"role":82,"phone":41,"phoneExt":41,"email":41},"Sung-Hyun Kim",{"name":113,"role":78,"phone":41,"phoneExt":41,"email":41},"Sung-Hyun Kim, MD, PhD",{"facility":115,"status":41,"city":116,"state":41,"zip":41,"country":90,"countryCode":41,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Inje University Ilsan Paik Hospital","Goyang",{"type":92,"coordinates":118},[119,120],127.19731,36.21689,{"lat":120,"lon":119},[123,125],{"name":124,"role":82,"phone":41,"phoneExt":41,"email":41},"Min Sun Kim",{"name":124,"role":78,"phone":41,"phoneExt":41,"email":41},{"facility":127,"status":41,"city":128,"state":41,"zip":41,"country":90,"countryCode":41,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Chung-Ang University Gwangmyeong Hospital","Gwangmyeong",{"type":92,"coordinates":130},[131,132],126.86639,37.47722,{"lat":132,"lon":131},[135,137],{"name":136,"role":82,"phone":41,"phoneExt":41,"email":41},"Eun Jeong Cho",{"name":136,"role":78,"phone":41,"phoneExt":41,"email":41},{"facility":139,"status":41,"city":140,"state":41,"zip":41,"country":90,"countryCode":41,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Chonnam National University Hwasun Hospital","Hwasun",{"type":92,"coordinates":142},[143,144],126.98746,35.06125,{"lat":144,"lon":143},[147,149],{"name":148,"role":82,"phone":41,"phoneExt":41,"email":41},"Hyukjin Park",{"name":148,"role":78,"phone":41,"phoneExt":41,"email":41},{"facility":151,"status":41,"city":152,"state":41,"zip":41,"country":90,"countryCode":41,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Chonbuk National University Hospital","Jeonju",{"type":92,"coordinates":154},[155,156],127.14889,35.82194,{"lat":156,"lon":155},[159,161],{"name":160,"role":82,"phone":41,"phoneExt":41,"email":41},"Ho-Young Yhim",{"name":162,"role":78,"phone":41,"phoneExt":41,"email":41},"Ho-Young Yhim, MD, PhD",{"facility":164,"status":41,"city":165,"state":41,"zip":41,"country":90,"countryCode":41,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Kangbuk Samsung Hospital","Seoul",{"type":92,"coordinates":167},[168,169],126.9784,37.566,{"lat":169,"lon":168},[172,174],{"name":173,"role":82,"phone":41,"phoneExt":41,"email":41},"Jiwon Kim",{"name":173,"role":78,"phone":41,"phoneExt":41,"email":41},{"facility":176,"status":41,"city":165,"state":41,"zip":41,"country":90,"countryCode":41,"cosmosGeoPoint":177,"geoPoint":179,"contacts":180},"Konkuk University Medical Center",{"type":92,"coordinates":178},[168,169],{"lat":169,"lon":168},[181,183],{"name":182,"role":82,"phone":41,"phoneExt":41,"email":41},"Ji-Won Hwang",{"name":182,"role":78,"phone":41,"phoneExt":41,"email":41},{"facility":185,"status":41,"city":165,"state":41,"zip":41,"country":90,"countryCode":41,"cosmosGeoPoint":186,"geoPoint":188,"contacts":189},"Korea University Anam Hospital",{"type":92,"coordinates":187},[168,169],{"lat":169,"lon":168},[190,192],{"name":191,"role":82,"phone":41,"phoneExt":41,"email":41},"So Ree Kim",{"name":191,"role":78,"phone":41,"phoneExt":41,"email":41},{"facility":5,"status":41,"city":165,"state":41,"zip":41,"country":90,"countryCode":41,"cosmosGeoPoint":194,"geoPoint":196,"contacts":197},{"type":92,"coordinates":195},[168,169],{"lat":169,"lon":168},[198,199,201,204,206],{"name":81,"role":82,"phone":41,"phoneExt":83,"email":84},{"name":200,"role":78,"phone":41,"phoneExt":41,"email":41},"Eun Kyoung Kim, MD, PhD",{"name":202,"role":203,"phone":41,"phoneExt":41,"email":41},"Se-Hoon Lee, MD, PhD","SUB_INVESTIGATOR",{"name":205,"role":203,"phone":41,"phoneExt":41,"email":41},"Taek Kyu Park, MD, PhD",{"name":207,"role":203,"phone":41,"phoneExt":41,"email":41},"David Hong, MD, PhD",{"facility":209,"status":41,"city":165,"state":41,"zip":41,"country":90,"countryCode":41,"cosmosGeoPoint":210,"geoPoint":212,"contacts":213},"Seoul National University Hospital",{"type":92,"coordinates":211},[168,169],{"lat":169,"lon":168},[214,216],{"name":215,"role":82,"phone":41,"phoneExt":41,"email":41},"Sang-Hoon Na, MD, PhD",{"name":215,"role":78,"phone":41,"phoneExt":41,"email":41},{"facility":218,"status":41,"city":165,"state":41,"zip":41,"country":90,"countryCode":41,"cosmosGeoPoint":219,"geoPoint":221,"contacts":222},"Seoul St. Mary's Hospital",{"type":92,"coordinates":220},[168,169],{"lat":169,"lon":168},[223,225],{"name":224,"role":82,"phone":41,"phoneExt":41,"email":41},"Mi-Hyang Jung",{"name":226,"role":78,"phone":41,"phoneExt":41,"email":41},"Mi-Hyang Jung, MD, PhD",{"type":78,"investigatorFullName":77,"investigatorTitle":228,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Professor",[230,231,234,235,236,238,239,240,242,244,245],{"name":209,"class":6},{"name":232,"class":233},"National Cancer Center, Korea","OTHER_GOV",{"name":218,"class":6},{"name":102,"class":6},{"name":237,"class":6},"Chonnam National University Hospital",{"name":185,"class":6},{"name":115,"class":6},{"name":241,"class":6},"Konkuk University Hospital",{"name":243,"class":6},"Kangbuk Samsung Hospital, Sungkyunkwan University",{"name":127,"class":6},{"name":151,"class":6},"100658505","phase-4-edoxaban-versus-apixaban-in-cancer-associated-venous-thromboembolism-100658505",false,"NCT07852637","Edoxaban Versus Apixaban in Cancer-Associated Venous Thromboembolism","Net Adverse Clinical Events With EdoXaban Versus Apixaban Treatment in Cancer-Associated Thrombosis","NEXT-CAT","Inclusion Criteria:\n\n1. Age ≥19 years.\n2. Objectively confirmed symptomatic or incidentally detected venous thromboembolism (VTE), including:\n\n   * Proximal deep vein thrombosis (DVT)\n   * Pulmonary embolism (PE)\n   * Both DVT and PE.\n3. Any type of active cancer, defined by at least one of the following:\n\n   * Cancer diagnosed within the previous 6 months\n   * Locally advanced or metastatic cancer\n   * Receipt of cancer-directed therapy (chemotherapy, immunotherapy, targeted therapy, endocrine therapy, radiotherapy, or cancer surgery) within the previous 6 months\n   * Cancer not in complete remission at the time of enrollment\n   * Ongoing cancer treatment or residual cancer.\n4. Ability to understand the risks, benefits, and treatment alternatives of the study and to voluntarily provide written informed consent.\n\nExclusion Criteria:\n\n1. Known hypersensitivity or contraindication to either study drug (edoxaban or apixaban).\n2. Severe renal impairment (creatinine clearance \\\u003C15 mL\u002Fmin) or dialysis.\n3. Active major bleeding.\n4. An indication requiring alternative anticoagulation, such as a mechanical heart valve or moderate-to-severe mitral stenosis.\n5. Antiphospholipid syndrome.\n6. Life expectancy \\\u003C6 months due to cancer progression or comorbid conditions, or anticipated poor treatment adherence, as determined by the investigator.\n7. Pregnancy or breastfeeding.\n8. Moderate or severe hepatic impairment classified as Child-Pugh class B or C.\n9. Thrombocytopenia with a platelet count \\\u003C50,000\u002Fmm³.","ALL","19 Years",{"count":257,"type":258},2300,"ESTIMATED","INTERVENTIONAL",[261],"PHASE4","This prospective, multicenter, randomized, open-label, blinded-endpoint trial aims to compare the clinical efficacy and safety of edoxaban-based treatment versus apixaban-based treatment in patients with cancer-associated venous thromboembolism (CAT). A total of 2,300 patients with active cancer and objectively confirmed venous thromboembolism will be randomized in a 1:1 ratio to receive edoxaban-based or apixaban-based treatment. The primary objective is to determine whether edoxaban-based treatment is non-inferior to apixaban-based treatment with respect to net adverse clinical events (NACE), defined as a composite of recurrent venous thromboembolism, venous thromboembolism-related death, or major bleeding according to the International Society on Thrombosis and Haemostasis criteria.",[264,265],"Venous Thromboembolism","Active Cancer",[267,268,264,269,270,271,272,72,273],"Cancer-Associated Thrombosis","Cancer-Associated Venous Thromboembolism","Deep Vein Thrombosis","Pulmonary Embolism","Direct Oral Anticoagulant","Edoxaban","Anticoagulation","NOT_YET_RECRUITING","2026-09-25",{"date":277,"type":278},"2026-10-01","ACTUAL",{"date":280,"type":258},"2026-11-01",{"date":282,"type":258},"2030-12-31",{"name":5,"class":6},12]