[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527574":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":45,"collaborators":18,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":18,"enrollmentInfo":59,"targetDuration":18,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":73,"whyStopped":18,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"The cohort 1","EXPERIMENTAL","The cohort 1 is treated with edoxaban to prevent catheter-related thrombosis.",[13],"Drug: Edoxaban",{"label":15,"type":16,"description":17,"interventionNames":18},"The cohort 2","NO_INTERVENTION","The cohort 2 won't be treated with edoxaban.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Edoxaban","Edoxaban, an oral selective factor Xa inhibitor, had been approved by the National Medical Products Administration in 2018. It is used for the treatment and recurrence prevention of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adults.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"fei ma","CONTACT","+8613910217780","drmafei@126.com",[32],{"facility":33,"status":18,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":18},"National Cancer Center\u002FNational Clinical Research Center for Cancer\u002FCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College","Beijing","Beijing Municipality","100021","China","CN",{"type":40,"coordinates":41},"Point",[42,43],116.39723,39.9075,{"lat":43,"lon":42},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Ma Fei，MD","Deputy Director of the Department of Medical Oncology","100527574","phase-3-evaluate-the-efficacy-and-safety-of-edoxaban-on-prevention-of-catheter-related-thrombosis-crt-in-cancer-patients-100527574",false,"NCT06149533","Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients","A Randomized, Multicenter, Open-Label, Control, Clinical Trial to Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients","Thrombosis","Inclusion Criteria:\n\n1. Age≥18.\n2. Cancer patients with a catheter-related thrombus risk prediction model score ≥ 19.6.\n3. ECOG score≤2.\n4. Expected survival period over 6 months.\n5. Malignant tumor was diagnosed by pathology and central venous catheterization was successfully completed.\n6. Signing of informed consent voluntarily.\n\nExclusion Criteria:\n\n1. Unknown location of the primary tumor.\n2. Allergy to the active ingredient of edoxaban tablets or other excipients.\n3. There is clinically significant active bleeding.\n4. Platelet \\\u003C50×109\u002FL.\n5. Liver disease with coagulopathy or clinically relevant bleeding risk.\n6. A lesion or condition with a significant risk of major bleeding, such as current or recent gastrointestinal ulcer, recent brain or spinal injury, recent brain, spinal, or ophthalmic surgery, recent intracranial hemorrhage, esophageal varices, arteriovenous malformations, vascular aneurysms, or major intravertebral or intracerebral vascular malformations.\n7. Concomitant therapy with any other anticoagulant, such as Unfractionated heparin (UFH), Low molecular heparin (Low molecular weight heparin, LMWH) (enoxaparin, dalteparin, etc.), heparin derivative (fondaparinux, etc.), oral anticoagulant (warfarin, dabigatran, rivaroxaban, apixaban, etc.), except in the special case of administration of UFH to maintain central venous catheter patency.\n8. Surgical treatment is planned for the duration of the study.\n9. Uncontrolled co-morbidities include, but are not limited to:\n\n   Serious, uncontrolled infection. Symptomatic heart failure (New York Heart Association class II-IV) or symptomatic or poorly controlled arrhythmias Uncontrolled hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) despite standard treatment.\n\n   Any arterial thromboembolic event within 6 months before enrollment. Tumor invasion of large vessels. History of deep vein thrombosis, pulmonary embolism, or other major thromboembolism within 3 months before enrollment.\n10. History of gastrointestinal perforation within 6 months before enrollment.\n11. Pregnant or breastfeeding women.\n12. Oral contraceptives.\n13. Conditions considered unsuitable for inclusion in this study.","ALL","18 Years",{"count":60,"type":61},366,"ESTIMATED","INTERVENTIONAL",[64],"PHASE3","To evaluate the efficacy and safety of edoxaban in the prevention of tumor catheter-related thrombosis (CVC\u002FPICC) in high-risk patients",[67,68,69],"Thrombosis, Venous","Cancer","Catheter Complications",[71,72,68,22],"Prevention","Catheter-related Thrombosis","NOT_YET_RECRUITING","2023-11-20",{"date":76,"type":77},"2023-11-29","ACTUAL",{"date":79,"type":61},"2023-11-30",{"date":81,"type":61},"2026-11-30",{"name":5,"class":6},1]