[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605297":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":55,"collaborators":30,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":30,"enrollmentInfo":67,"targetDuration":30,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":30,"overallStatus":76,"whyStopped":30,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"University of Birmingham","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Apixaban","EXPERIMENTAL","apixaban 2.5 mg twice a day for 6 months",[13],"Drug: Apixaban",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","apixaban matched placebo twice a day for 6 months",[19],"Other: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","apixaban 2.5mg twice a day for 6 months",[9],[26],"eliquis",{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Placebo twice a day for 6 months",[15],null,[32],{"name":33,"affiliation":5,"role":34},"Michael Newnham, MBChB, MSc, MRCP, PhD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":30,"email":40},"Ann Pope, PhD","CONTACT","+44 4146372","THROMBO-STOP@trials.bham.ac.uk",{"name":42,"role":38,"phone":30,"phoneExt":30,"email":40},"Sophia Magwaro, BSc",[44],{"facility":5,"status":30,"city":45,"state":30,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":30},"Birmingham","B15 2TT","United Kingdom","UK",{"type":50,"coordinates":51},"Point",[52,53],-1.89983,52.48142,{"lat":53,"lon":52},{"type":56,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100605297","phase-3-apixaban-to-prevent-venous-thromboembolism-in-ambulatory-lung-cancer-patients-undergoing-systemic-anticancer-treatment-100605297",false,"NCT07160686","Apixaban to Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment","A Phase III, Multicentre, Double Blind, Placebo-Controlled, Randomised Clinical Trial of Apixaban THROMBOprophylaxiS TO Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment","THROMBO-STOP","Inclusion criteria\n\n* Age ≥ 16 years\n* Newly diagnosed locally advanced or metastatic primary lung cancer (histologically\u002F cytologically confirmed) or disease progression after complete or partial remission commencing a new course of SACT alone or as CRT\n* Ambulatory (receiving outpatient SACT)\n\nExclusion criteria\n\n* Hypersensitivity to apixaban or to any of the listed SmPC excipients\n* Active clinically significant bleeding\n* Lesion or condition considered a significant risk factor for major bleeding\n* Hepatic disease associated with impaired synthetic function\n* Platelet count \\\u003C 50 x 109 \u002FL\n* Elevated liver enzymes ALT\u002FAST \\> 2 x ULN or total bilirubin ≥ 1.5 x ULN\n* Renal failure (creatinine clearance \\\u003C 15ml\u002Fmin)\n* Weight \\\u003C 40kg\n* Estimated life expectancy \\\u003C 6 months\n* Continuous anticoagulation (e.g., unfractionated heparin, low molecular weight heparins, heparin derivatives and oral anticoagulants) for other medical conditions\n* The usage of medications contraindicated with apixaban\n* Pregnancy\n* Breast feeding\n* Judgement by the Investigator that the participant is unsuitable to participate in the trial and the participant is unlikely to comply with trial procedures, restrictions and requirements\n* Inability to consent\n* Receiving SACT for potentially resectable \u002F resectable lung cancer as part of neo-adjuvant or adjuvant treatment\n* SACT with significant potential DDI with apixaban (section 7.2.3)","ALL","16 Years",{"count":68,"type":69},1456,"ESTIMATED","INTERVENTIONAL",[72],"PHASE3","The aim of this trial is to find out if a tablet called apixaban can reduce blood clots in people with lung cancer having chemotherapy or similar treatments. Apixaban is a type of oral anticoagulant (\"blood thinner\") that makes the blood less sticky to prevent blood clots forming.\n\nThe trial is trying to find out if apixaban it can reduce blood clots in people with lung cancer.\n\nParticipants will receive the following treatment:\n\n• Apixaban or placebo, 2.5mg taken by mouth twice a day for 6 months. This treatment will be taken in addition to any treatment that they are receiving to treat their lung cancer.\n\nParticipants will need to:\n\n* Sign a consent form to enter the trial.\n* Take the trial treatment as directed by the research team\n* Complete a participant diary to record when they took the trial treatment\n* Complete the Quality of Life and Health resource use questionnaires.\n* Female participants of childbearing potential must use adequate contraception during the trial and for at least 2 days after trial treatment has finished.",[75],"Thromboprophylaxis","NOT_YET_RECRUITING","2025-09-01",{"date":79,"type":80},"2025-09-08","ACTUAL",{"date":82,"type":69},"2026-03-02",{"date":84,"type":69},"2030-03-30",{"name":5,"class":6},1]