[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07213778":3,"trial-entities:NCT07213778":352,"trial-summary:NCT07213778":356},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":48,"secondary_outcomes":52,"sex":82,"minimum_age":83,"maximum_age":17,"healthy_volunteers":84,"eligibility_criteria":85,"std_ages":89,"locations":92,"central_contacts":340,"overall_officials":346,"references":350,"see_also_links":351},"NCT07213778","R7508-DVT-24120","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)","RECRUITING","2027-07-16","2026-08","2026-08-19","2025-11-24","Regeneron Pharmaceuticals","INDUSTRY",true,"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)",null,[19],"Symptomatic Venous Thromboembolism (VTE)",[21,22,23,24],"Total Knee Arthroplasty (TKA)","Elective Unilateral TKA","Deep Vein Thrombosis (DVT)","Pulmonary Embolism (PE)","INTERVENTIONAL","TREATMENT",[28],"PHASE3",{"count":30,"type":31},2000,"ESTIMATED",[33,41,45],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"DRUG","REGN7508","Administered per the protocol",[38],"REGN7508 and Placebo",[40],"cenvacibart",{"type":34,"name":42,"description":36,"armGroupLabels":43},"Acetylsalicylic Acid (ASA)",[44],"Placebo and ASA",{"type":34,"name":46,"description":36,"armGroupLabels":47},"Placebo",[44,38],[49],{"measure":50,"timeFrame":51},"Incidence of the composite endpoint of symptomatic VTE and all-cause death","Through day 30 visit",[53,55,57,59,61,63,65,67,69,71,74,76,78,80],{"measure":54,"timeFrame":51},"Time to first event of the composite endpoint of symptomatic VTE and all-cause death",{"measure":56,"timeFrame":51},"Incidence of confirmed symptomatic Deep Vein Thrombosis (DVT)",{"measure":58,"timeFrame":51},"Incidence of confirmed Pulmonary Embolism (PE)",{"measure":60,"timeFrame":51},"Incidence of all-cause death",{"measure":62,"timeFrame":51},"Time to first event of the confirmed symptomatic DVT",{"measure":64,"timeFrame":51},"Time to first event of the confirmed PE",{"measure":66,"timeFrame":51},"Time to the all-cause death",{"measure":68,"timeFrame":51},"Incidence of the composite endpoint of major bleeding and Clinically Relevant Non-Major (CRNM) bleeding",{"measure":70,"timeFrame":51},"Incidence of minor bleeding",{"measure":72,"timeFrame":73},"Incidence of Treatment-Emergent Adverse Events (TEAEs)","Through day 90 visit",{"measure":75,"timeFrame":73},"Severity of TEAEs",{"measure":77,"timeFrame":73},"Incidence of Anti-drug Antibody (ADA) to REGN7508",{"measure":79,"timeFrame":73},"Magnitude of ADA to REGN7508",{"measure":81,"timeFrame":73},"Concentrations of REGN7508","ALL","18 Years",false,{"inclusion":86,"exclusion":87,"raw_text":88},[],[],"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",[90,91],"ADULT","OLDER_ADULT",[93,102,109,117,125,132,139,146,154,162,170,178,185,193,197,205,213,221,224,231,239,246,250,258,266,270,277,282,290,298,307,316,324,332],{"facility":94,"status":8,"city":95,"state":96,"zip":97,"country":98,"geoPoint":99},"Horizon Clinical Research","La Mesa","California","91942","United States",{"lat":100,"lon":101},32.76783,-117.02308,{"facility":103,"status":8,"city":104,"state":96,"zip":105,"country":98,"geoPoint":106},"Eisenhower Medical Center","Rancho Mirage","92270",{"lat":107,"lon":108},33.73974,-116.41279,{"facility":110,"status":8,"city":111,"state":112,"zip":113,"country":98,"geoPoint":114},"Sky Ridge Medical Center","Lone Tree","Colorado","80124",{"lat":115,"lon":116},39.55171,-104.8863,{"facility":118,"status":8,"city":119,"state":120,"zip":121,"country":98,"geoPoint":122},"South Florida Joint Replacement Center","Deerfield Beach","Florida","33064",{"lat":123,"lon":124},26.31841,-80.09977,{"facility":126,"status":8,"city":127,"state":120,"zip":128,"country":98,"geoPoint":129},"Medical Research of Westchester - MPLUS Research Network","Miami","33165",{"lat":130,"lon":131},25.77427,-80.19366,{"facility":133,"status":8,"city":134,"state":120,"zip":135,"country":98,"geoPoint":136},"Larkin Community Hospital South Miami","South Miami","33143",{"lat":137,"lon":138},25.7076,-80.29338,{"facility":140,"status":8,"city":141,"state":120,"zip":142,"country":98,"geoPoint":143},"Phoenix Clinical Research","Tamarac","33321",{"lat":144,"lon":145},26.21286,-80.24977,{"facility":147,"status":8,"city":148,"state":149,"zip":150,"country":98,"geoPoint":151},"Endeavor Health","Skokie","Illinois","60076",{"lat":152,"lon":153},42.03336,-87.73339,{"facility":155,"status":8,"city":156,"state":157,"zip":158,"country":98,"geoPoint":159},"The Orthopaedic Research Foundation, Inc.","Indianapolis","Indiana","46278",{"lat":160,"lon":161},39.76838,-86.15804,{"facility":163,"status":8,"city":164,"state":165,"zip":166,"country":98,"geoPoint":167},"NextStage Clinical Research, St. Francis Medical Park","Wichita","Kansas","67214",{"lat":168,"lon":169},37.69224,-97.33754,{"facility":171,"status":8,"city":172,"state":173,"zip":174,"country":98,"geoPoint":175},"Velocity Clinical Research, Annapolis","Annapolis","Maryland","21401",{"lat":176,"lon":177},38.97859,-76.49184,{"facility":179,"status":8,"city":180,"state":173,"zip":181,"country":98,"geoPoint":182},"Sinai Hospital of Baltimore, Inc.","Baltimore","21215",{"lat":183,"lon":184},39.29038,-76.61219,{"facility":186,"status":8,"city":187,"state":188,"zip":189,"country":98,"geoPoint":190},"Tufts Medical Center","Boston","Massachusetts","02111",{"lat":191,"lon":192},42.35843,-71.05977,{"facility":194,"status":8,"city":187,"state":188,"zip":195,"country":98,"geoPoint":196},"Boston Medical Center","02118",{"lat":191,"lon":192},{"facility":198,"status":8,"city":199,"state":200,"zip":201,"country":98,"geoPoint":202},"Holy Name Medical Center","Teaneck","New Jersey","07666",{"lat":203,"lon":204},40.8976,-74.01597,{"facility":206,"status":8,"city":207,"state":208,"zip":209,"country":98,"geoPoint":210},"University of Rochester Medical Center","Rochester","New York","14623-5863",{"lat":211,"lon":212},43.15478,-77.61556,{"facility":214,"status":8,"city":215,"state":216,"zip":217,"country":98,"geoPoint":218},"Eximia Equihealth Research-Raleigh. LLC","Raleigh","North Carolina","27612",{"lat":219,"lon":220},35.7721,-78.63861,{"facility":222,"status":8,"city":215,"state":216,"zip":217,"country":98,"geoPoint":223},"The Vein and Vascular Center at Raleigh Radiology",{"lat":219,"lon":220},{"facility":225,"status":8,"city":226,"state":216,"zip":227,"country":98,"geoPoint":228},"Coastal Vascular Institute, PA","Wilmington","28401",{"lat":229,"lon":230},34.23556,-77.94604,{"facility":232,"status":8,"city":233,"state":234,"zip":235,"country":98,"geoPoint":236},"University of Cincinnati","Cincinnati","Ohio","45267",{"lat":237,"lon":238},39.12711,-84.51439,{"facility":240,"status":8,"city":241,"state":234,"zip":242,"country":98,"geoPoint":243},"The Ohio State University Wexner Medical Center","Columbus","43210",{"lat":244,"lon":245},39.96118,-82.99879,{"facility":247,"status":8,"city":241,"state":234,"zip":248,"country":98,"geoPoint":249},"Ohio Clinical Trials","43212",{"lat":244,"lon":245},{"facility":251,"status":8,"city":252,"state":253,"zip":254,"country":98,"geoPoint":255},"University of Pittsburgh","Pittsburgh","Pennsylvania","15213-3108",{"lat":256,"lon":257},40.44062,-79.99589,{"facility":259,"status":8,"city":260,"state":261,"zip":262,"country":98,"geoPoint":263},"HD Research - Memorial Hermann Village","Houston","Texas","77043",{"lat":264,"lon":265},29.76328,-95.36327,{"facility":267,"status":8,"city":260,"state":261,"zip":268,"country":98,"geoPoint":269},"NextStage Clinical Research, All American Orthopedics and Sports Medicine","77058",{"lat":264,"lon":265},{"facility":271,"status":8,"city":272,"state":261,"zip":273,"country":98,"geoPoint":274},"Flourish Research - San Antonio (Formerly Clinical Trials of Texas)","San Antonio","78229",{"lat":275,"lon":276},29.42412,-98.49363,{"facility":278,"status":279,"city":272,"state":261,"zip":280,"country":98,"geoPoint":281},"Endeavor Clinical Trials","WITHDRAWN","78240",{"lat":275,"lon":276},{"facility":283,"status":8,"city":284,"state":285,"zip":286,"country":98,"geoPoint":287},"Carilion Clinic","Roanoke","Virginia","24015",{"lat":288,"lon":289},37.27097,-79.94143,{"facility":291,"status":8,"city":292,"state":293,"zip":294,"country":98,"geoPoint":295},"Spokane Joint Replacement Center","Spokane","Washington","99218",{"lat":296,"lon":297},47.65966,-117.42908,{"facility":299,"status":8,"city":300,"state":301,"zip":302,"country":303,"geoPoint":304},"Henry Dunant Hospital Center","Athens","Attica","11526","Greece",{"lat":305,"lon":306},37.98376,23.72784,{"facility":308,"status":8,"city":309,"state":310,"zip":311,"country":312,"geoPoint":313},"Sultan Abdul Halim Hospital","Sungai Petani","Kedah","08000","Malaysia",{"lat":314,"lon":315},5.647,100.48772,{"facility":317,"status":8,"city":318,"state":319,"zip":320,"country":312,"geoPoint":321},"Hospital Tengku Ampuan Afzan (HTTA)","Kuantan","Pahang","25100",{"lat":322,"lon":323},3.8077,103.326,{"facility":325,"status":8,"city":326,"state":327,"zip":328,"country":312,"geoPoint":329},"Hospital Queen Elizabeth II","Kota Kinabalu","Sabah","88300",{"lat":330,"lon":331},5.9749,116.0724,{"facility":333,"status":8,"city":334,"zip":335,"country":336,"geoPoint":337},"PMSI Emergency Medicine Institute","Chisinau","MD-2004","Moldova",{"lat":338,"lon":339},47.00902,28.85938,[341],{"name":342,"role":343,"phone":344,"email":345},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",[347],{"name":348,"affiliation":13,"role":349},"Clinical Trial Management","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":353,"biomarkers":355},[354],"Total Knee Replacement",[],{"nct_id":4,"found":15,"summary":357,"prompt_version":367},{"design":358,"status":359,"heading":360,"summary":361,"follow_up":362,"word_count":363,"commitments":364,"compensation":365,"drugs_mentioned":366},"This is an interventional study comparing REGN7508, Acetylsalicylic Acid (ASA), and a placebo. It plans to enroll 2000 participants.","completed","REGN7508 for Preventing Blood Clots After Knee Replacement","This study is testing an experimental drug called REGN7508 against a common treatment, Acetylsalicylic Acid (ASA), also known as aspirin. The goal is to see how well REGN7508 prevents blood clots (Venous Thromboembolism or VTE) and other related health issues after total knee replacement surgery. You might be able to join if you are an adult having elective, single-side total knee replacement surgery and are in good health. The main way we'll know if the study is successful is by looking at how many people experience VTE or death from any cause up to 30 days after their surgery. This study is currently recruiting about 2000 participants.","Participants will be followed through a 30-day visit after their surgery.",107,"Not specified in the trial record.","Not stated in the trial record.",[35,42],"v2"]