[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609376":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":366,"collaborators":11,"id":368,"slug":369,"hasResults":370,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":370,"sex":376,"minAge":377,"maxAge":11,"enrollmentInfo":378,"targetDuration":11,"studyType":381,"phases":382,"briefSummary":384,"conditions":385,"keywords":387,"overallStatus":47,"whyStopped":11,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":401},{"fullName":5,"class":6},"Regeneron Pharmaceuticals","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"REGN7508 and Placebo","EXPERIMENTAL",null,[13,14],"Drug: REGN7508","Drug: Placebo",{"label":16,"type":17,"description":11,"interventionNames":18},"Placebo and ASA","ACTIVE_COMPARATOR",[19,14],"Drug: Acetylsalicylic Acid (ASA)",[21,28,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","REGN7508","Administered per the protocol",[9],[27],"cenvacibart",{"type":22,"name":29,"description":24,"armGroupLabels":30,"otherNames":11},"Acetylsalicylic Acid (ASA)",[16],{"type":22,"name":32,"description":24,"armGroupLabels":33,"otherNames":11},"Placebo",[16,9],[35],{"name":36,"affiliation":5,"role":37},"Clinical Trial Management","STUDY_DIRECTOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":11,"email":43},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",[45,59,68,78,88,97,106,115,125,135,145,155,164,174,180,190,200,210,215,224,234,243,249,259,269,275,284,291,301,311,323,335,345,355],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":11},"Horizon Clinical Research","RECRUITING","La Mesa","California","91942","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-117.02308,32.76783,{"lat":57,"lon":56},{"facility":60,"status":47,"city":61,"state":49,"zip":62,"country":51,"countryCode":52,"cosmosGeoPoint":63,"geoPoint":67,"contacts":11},"Eisenhower Medical Center","Rancho Mirage","92270",{"type":54,"coordinates":64},[65,66],-116.41279,33.73974,{"lat":66,"lon":65},{"facility":69,"status":47,"city":70,"state":71,"zip":72,"country":51,"countryCode":52,"cosmosGeoPoint":73,"geoPoint":77,"contacts":11},"Sky Ridge Medical Center","Lone Tree","Colorado","80124",{"type":54,"coordinates":74},[75,76],-104.8863,39.55171,{"lat":76,"lon":75},{"facility":79,"status":47,"city":80,"state":81,"zip":82,"country":51,"countryCode":52,"cosmosGeoPoint":83,"geoPoint":87,"contacts":11},"South Florida Joint Replacement Center","Deerfield Beach","Florida","33064",{"type":54,"coordinates":84},[85,86],-80.09977,26.31841,{"lat":86,"lon":85},{"facility":89,"status":47,"city":90,"state":81,"zip":91,"country":51,"countryCode":52,"cosmosGeoPoint":92,"geoPoint":96,"contacts":11},"Medical Research of Westchester - MPLUS Research Network","Miami","33165",{"type":54,"coordinates":93},[94,95],-80.19366,25.77427,{"lat":95,"lon":94},{"facility":98,"status":47,"city":99,"state":81,"zip":100,"country":51,"countryCode":52,"cosmosGeoPoint":101,"geoPoint":105,"contacts":11},"Larkin Community Hospital South Miami","South Miami","33143",{"type":54,"coordinates":102},[103,104],-80.29338,25.7076,{"lat":104,"lon":103},{"facility":107,"status":47,"city":108,"state":81,"zip":109,"country":51,"countryCode":52,"cosmosGeoPoint":110,"geoPoint":114,"contacts":11},"Phoenix Clinical Research","Tamarac","33321",{"type":54,"coordinates":111},[112,113],-80.24977,26.21286,{"lat":113,"lon":112},{"facility":116,"status":47,"city":117,"state":118,"zip":119,"country":51,"countryCode":52,"cosmosGeoPoint":120,"geoPoint":124,"contacts":11},"Endeavor Health","Skokie","Illinois","60076",{"type":54,"coordinates":121},[122,123],-87.73339,42.03336,{"lat":123,"lon":122},{"facility":126,"status":47,"city":127,"state":128,"zip":129,"country":51,"countryCode":52,"cosmosGeoPoint":130,"geoPoint":134,"contacts":11},"The Orthopaedic Research Foundation, Inc.","Indianapolis","Indiana","46278",{"type":54,"coordinates":131},[132,133],-86.15804,39.76838,{"lat":133,"lon":132},{"facility":136,"status":47,"city":137,"state":138,"zip":139,"country":51,"countryCode":52,"cosmosGeoPoint":140,"geoPoint":144,"contacts":11},"NextStage Clinical Research, St. Francis Medical Park","Wichita","Kansas","67214",{"type":54,"coordinates":141},[142,143],-97.33754,37.69224,{"lat":143,"lon":142},{"facility":146,"status":47,"city":147,"state":148,"zip":149,"country":51,"countryCode":52,"cosmosGeoPoint":150,"geoPoint":154,"contacts":11},"Velocity Clinical Research, Annapolis","Annapolis","Maryland","21401",{"type":54,"coordinates":151},[152,153],-76.49184,38.97859,{"lat":153,"lon":152},{"facility":156,"status":47,"city":157,"state":148,"zip":158,"country":51,"countryCode":52,"cosmosGeoPoint":159,"geoPoint":163,"contacts":11},"Sinai Hospital of Baltimore, Inc.","Baltimore","21215",{"type":54,"coordinates":160},[161,162],-76.61219,39.29038,{"lat":162,"lon":161},{"facility":165,"status":47,"city":166,"state":167,"zip":168,"country":51,"countryCode":52,"cosmosGeoPoint":169,"geoPoint":173,"contacts":11},"Tufts Medical Center","Boston","Massachusetts","02111",{"type":54,"coordinates":170},[171,172],-71.05977,42.35843,{"lat":172,"lon":171},{"facility":175,"status":47,"city":166,"state":167,"zip":176,"country":51,"countryCode":52,"cosmosGeoPoint":177,"geoPoint":179,"contacts":11},"Boston Medical Center","02118",{"type":54,"coordinates":178},[171,172],{"lat":172,"lon":171},{"facility":181,"status":47,"city":182,"state":183,"zip":184,"country":51,"countryCode":52,"cosmosGeoPoint":185,"geoPoint":189,"contacts":11},"Holy Name Medical Center","Teaneck","New Jersey","07666",{"type":54,"coordinates":186},[187,188],-74.01597,40.8976,{"lat":188,"lon":187},{"facility":191,"status":47,"city":192,"state":193,"zip":194,"country":51,"countryCode":52,"cosmosGeoPoint":195,"geoPoint":199,"contacts":11},"University of Rochester Medical Center","Rochester","New York","14623-5863",{"type":54,"coordinates":196},[197,198],-77.61556,43.15478,{"lat":198,"lon":197},{"facility":201,"status":47,"city":202,"state":203,"zip":204,"country":51,"countryCode":52,"cosmosGeoPoint":205,"geoPoint":209,"contacts":11},"Eximia Equihealth Research-Raleigh. LLC","Raleigh","North Carolina","27612",{"type":54,"coordinates":206},[207,208],-78.63861,35.7721,{"lat":208,"lon":207},{"facility":211,"status":47,"city":202,"state":203,"zip":204,"country":51,"countryCode":52,"cosmosGeoPoint":212,"geoPoint":214,"contacts":11},"The Vein and Vascular Center at Raleigh Radiology",{"type":54,"coordinates":213},[207,208],{"lat":208,"lon":207},{"facility":216,"status":47,"city":217,"state":203,"zip":218,"country":51,"countryCode":52,"cosmosGeoPoint":219,"geoPoint":223,"contacts":11},"Coastal Vascular Institute, PA","Wilmington","28401",{"type":54,"coordinates":220},[221,222],-77.94604,34.23556,{"lat":222,"lon":221},{"facility":225,"status":47,"city":226,"state":227,"zip":228,"country":51,"countryCode":52,"cosmosGeoPoint":229,"geoPoint":233,"contacts":11},"University of Cincinnati","Cincinnati","Ohio","45267",{"type":54,"coordinates":230},[231,232],-84.51439,39.12711,{"lat":232,"lon":231},{"facility":235,"status":47,"city":236,"state":227,"zip":237,"country":51,"countryCode":52,"cosmosGeoPoint":238,"geoPoint":242,"contacts":11},"The Ohio State University Wexner Medical Center","Columbus","43210",{"type":54,"coordinates":239},[240,241],-82.99879,39.96118,{"lat":241,"lon":240},{"facility":244,"status":47,"city":236,"state":227,"zip":245,"country":51,"countryCode":52,"cosmosGeoPoint":246,"geoPoint":248,"contacts":11},"Ohio Clinical Trials","43212",{"type":54,"coordinates":247},[240,241],{"lat":241,"lon":240},{"facility":250,"status":47,"city":251,"state":252,"zip":253,"country":51,"countryCode":52,"cosmosGeoPoint":254,"geoPoint":258,"contacts":11},"University of Pittsburgh","Pittsburgh","Pennsylvania","15213-3108",{"type":54,"coordinates":255},[256,257],-79.99589,40.44062,{"lat":257,"lon":256},{"facility":260,"status":47,"city":261,"state":262,"zip":263,"country":51,"countryCode":52,"cosmosGeoPoint":264,"geoPoint":268,"contacts":11},"HD Research - Memorial Hermann Village","Houston","Texas","77043",{"type":54,"coordinates":265},[266,267],-95.36327,29.76328,{"lat":267,"lon":266},{"facility":270,"status":47,"city":261,"state":262,"zip":271,"country":51,"countryCode":52,"cosmosGeoPoint":272,"geoPoint":274,"contacts":11},"NextStage Clinical Research, All American Orthopedics and Sports Medicine","77058",{"type":54,"coordinates":273},[266,267],{"lat":267,"lon":266},{"facility":276,"status":47,"city":277,"state":262,"zip":278,"country":51,"countryCode":52,"cosmosGeoPoint":279,"geoPoint":283,"contacts":11},"Flourish Research - San Antonio (Formerly Clinical Trials of Texas)","San Antonio","78229",{"type":54,"coordinates":280},[281,282],-98.49363,29.42412,{"lat":282,"lon":281},{"facility":285,"status":286,"city":277,"state":262,"zip":287,"country":51,"countryCode":52,"cosmosGeoPoint":288,"geoPoint":290,"contacts":11},"Endeavor Clinical Trials","WITHDRAWN","78240",{"type":54,"coordinates":289},[281,282],{"lat":282,"lon":281},{"facility":292,"status":47,"city":293,"state":294,"zip":295,"country":51,"countryCode":52,"cosmosGeoPoint":296,"geoPoint":300,"contacts":11},"Carilion Clinic","Roanoke","Virginia","24015",{"type":54,"coordinates":297},[298,299],-79.94143,37.27097,{"lat":299,"lon":298},{"facility":302,"status":47,"city":303,"state":304,"zip":305,"country":51,"countryCode":52,"cosmosGeoPoint":306,"geoPoint":310,"contacts":11},"Spokane Joint Replacement Center","Spokane","Washington","99218",{"type":54,"coordinates":307},[308,309],-117.42908,47.65966,{"lat":309,"lon":308},{"facility":312,"status":47,"city":313,"state":314,"zip":315,"country":316,"countryCode":317,"cosmosGeoPoint":318,"geoPoint":322,"contacts":11},"Henry Dunant Hospital Center","Athens","Attica","11526","Greece","GR",{"type":54,"coordinates":319},[320,321],23.72784,37.98376,{"lat":321,"lon":320},{"facility":324,"status":47,"city":325,"state":326,"zip":327,"country":328,"countryCode":329,"cosmosGeoPoint":330,"geoPoint":334,"contacts":11},"Sultan Abdul Halim Hospital","Sungai Petani","Kedah","08000","Malaysia","MY",{"type":54,"coordinates":331},[332,333],100.48772,5.647,{"lat":333,"lon":332},{"facility":336,"status":47,"city":337,"state":338,"zip":339,"country":328,"countryCode":329,"cosmosGeoPoint":340,"geoPoint":344,"contacts":11},"Hospital Tengku Ampuan Afzan (HTTA)","Kuantan","Pahang","25100",{"type":54,"coordinates":341},[342,343],103.326,3.8077,{"lat":343,"lon":342},{"facility":346,"status":47,"city":347,"state":348,"zip":349,"country":328,"countryCode":329,"cosmosGeoPoint":350,"geoPoint":354,"contacts":11},"Hospital Queen Elizabeth II","Kota Kinabalu","Sabah","88300",{"type":54,"coordinates":351},[352,353],116.0724,5.9749,{"lat":353,"lon":352},{"facility":356,"status":47,"city":357,"state":11,"zip":358,"country":359,"countryCode":360,"cosmosGeoPoint":361,"geoPoint":365,"contacts":11},"PMSI Emergency Medicine Institute","Chisinau","MD-2004","Moldova","MD",{"type":54,"coordinates":362},[363,364],28.85938,47.00902,{"lat":364,"lon":363},{"type":367,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100609376","phase-3-regn7508-versus-acetylsalicylic-acid-asa-for-venous-thromboprophylaxis-after-total-knee-arthroplasty-in-adult-participants-100609376",false,"NCT07213778","REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants","A Phase 3, Multicenter, Double-Blinded, Randomized Study to Evaluate REGN7508, a Factor XI Monoclonal Antibody, Versus Acetylsalicylic Acid for Prophylaxis of Symptomatic Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-ASPEN)","ROXI-ASPEN","Key Inclusion Criteria:\n\n1. Is undergoing a primary elective unilateral TKA\n2. Is in good health based on laboratory safety testing as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation\n2. History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis (eg, hemophilia A or B, von Willebrand's Factor deficiency)\n3. History of thromboembolic disease or thrombophilia\n4. History of platelet dysfunction\n5. Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery\n\nNote: Other protocol-defined Inclusion\u002F Exclusion criteria apply","ALL","18 Years",{"count":379,"type":380},2000,"ESTIMATED","INTERVENTIONAL",[383],"PHASE3","This study is researching an experimental drug called REGN7508 (called \"study drug\") and how it compares against another treatment called Acetylsalicylic Acid (ASA). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery.\n\nThe aim of the study is to see how effective the study drug is at preventing Venous Thromboembolism (VTE) and other related diseases after total knee replacement surgery compared to acetylsalicylic acid.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)",[386],"Symptomatic Venous Thromboembolism (VTE)",[388,389,390,391],"Total Knee Arthroplasty (TKA)","Elective Unilateral TKA","Deep Vein Thrombosis (DVT)","Pulmonary Embolism (PE)","2026-08-17",{"date":394,"type":395},"2026-08-19","ACTUAL",{"date":397,"type":395},"2025-11-24",{"date":399,"type":380},"2027-07-16",{"name":5,"class":6},34]