[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07318610":3,"trial-entities:NCT07318610":267,"trial-summary:NCT07318610":272},{"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":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":51,"secondary_outcomes":58,"sex":113,"minimum_age":114,"maximum_age":17,"healthy_volunteers":115,"eligibility_criteria":116,"std_ages":120,"locations":123,"central_contacts":255,"overall_officials":261,"references":265,"see_also_links":266},"NCT07318610","R9933-PAD-2394","Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease","A Master Protocol for a Phase 3, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, in Participants With Recent Lower Extremity Revascularization for Symptomatic Peripheral Artery Disease (ROXI-PALISADE)","RECRUITING","2029-11-16","2026-08","2026-08-19","2026-07-10","Regeneron Pharmaceuticals","INDUSTRY",true,"This study is researching 2 different experimental drugs called REGN7508 and REGN9933. The study is focused on people who have Peripheral Artery Disease (PAD), which means that the blood vessels in their arms and legs have become too narrow. People with PAD have a higher risk of getting blood clots after procedures like Lower Extremity Revascularization (LER), a procedure to improve blood flow in the legs and feet.\n\nThe aim of this study is to see how well REGN7508 and REGN9933 prevent life-threatening blood clots in participants with PAD who have recently had LER. The effects of REGN7508 and REGN9933, individually, will also be compared to rivaroxaban and a placebo.\n\nThe study is looking at several other research questions, including:\n\n* What side effects might happen from taking the study drugs and how do they compare to the side effects of rivaroxaban\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)\n* If the study drugs affect the ability of the blood to clot normally",null,[19],"Peripheral Artery Disease (PAD)",[21,22],"Blood clots","Lower Extremity Revascularization (LER)","INTERVENTIONAL","TREATMENT",[26],"PHASE3",{"count":28,"type":29},7050,"ESTIMATED",[31,40,45,48],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":38},"DRUG","REGN7508","Administered per the protocol",[36,37],"Cohort 1","Cohort 2",[39],"cenvacibart",{"type":32,"name":41,"description":34,"armGroupLabels":42,"otherNames":43},"REGN9933",[36,37],[44],"amrecibart",{"type":32,"name":46,"description":34,"armGroupLabels":47},"Placebo",[36],{"type":32,"name":49,"description":34,"armGroupLabels":50},"Rivaroxaban",[37],[52,55],{"measure":53,"description":36,"timeFrame":54},"Time-to-first occurrence of a major thrombotic vascular event, consisting of Acute Limb Ischemia (ALI), major amputation (above the ankle) of vascular etiology, Myocardial Infarction (MI), ischemic stroke, or Cardiovascular (CV) death","Approximately up to 42 months",{"measure":56,"description":57,"timeFrame":54},"Time-to-first occurrence of International Society of Thrombosis and Hemostasis (ISTH) major or Clinically Relevant Non-major (CRNM) bleeding","Cohort 1 and 2",[59,61,63,65,67,69,71,73,75,77,79,81,83,86,88,90,92,94,96,98,100,103,105,107,109,111],{"measure":60,"description":57,"timeFrame":54},"Total (first and subsequent) occurrences of major thrombotic vascular events, consisting of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke, or CV death",{"measure":62,"description":57,"timeFrame":54},"Time-to-first occurrence of an expanded thrombotic vascular event, consisting of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke, CV death, unplanned index limb revascularization, or Venous Thromboembolism (VTE)",{"measure":64,"description":36,"timeFrame":54},"Time-to-first occurrence of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke or coronary death",{"measure":66,"description":36,"timeFrame":54},"Time-to-first occurrence of vascular hospitalization for a coronary cerebrovascular, or peripheral event of thrombotic nature",{"measure":68,"description":36,"timeFrame":54},"Time-to-first occurrence of ALI, major amputation of vascular etiology, MI, ischemic stroke, or all-cause mortality",{"measure":70,"description":36,"timeFrame":54},"Time-to-first occurrence of unplanned index limb revascularization for ischemia",{"measure":72,"description":36,"timeFrame":54},"Time-to-first occurrence of VTE",{"measure":74,"description":36,"timeFrame":54},"Time-to-all-cause mortality",{"measure":76,"description":36,"timeFrame":54},"Time-to-first occurrence of Major Adverse Limb Event (MALE)",{"measure":78,"description":36,"timeFrame":54},"Time-to-first occurrence of Major Adverse Cardiovascular Event (MACE)",{"measure":80,"description":36,"timeFrame":54},"Time-to-first occurrence of a major thrombotic vascular event or ISTH fatal\u002Fcritical organ bleeding (net clinical benefit)",{"measure":82,"description":57,"timeFrame":54},"Time-to-first occurrence of Thrombolysis in Myocardial Infarction (TIMI) major bleeding",{"measure":84,"description":57,"timeFrame":85},"Occurrence of Treatment-Emergent Adverse Event (TEAEs)","Approximately up to 45 months",{"measure":87,"description":57,"timeFrame":85},"Severity of TEAEs",{"measure":89,"description":57,"timeFrame":85},"Occurrence of Anti-Drug Antibody (ADA) to REGN7508 over time",{"measure":91,"description":57,"timeFrame":85},"Magnitude of ADA to REGN7508 over time",{"measure":93,"description":57,"timeFrame":85},"Occurrence of ADA to REGN9933 over time",{"measure":95,"description":57,"timeFrame":85},"Magnitude of ADA to REGN9933 over time",{"measure":97,"description":57,"timeFrame":85},"Concentrations of REGN7508 over time",{"measure":99,"description":57,"timeFrame":85},"Concentrations of REGN9933 over time",{"measure":101,"description":57,"timeFrame":102},"Change from baseline in activated Partial Thromboplastin Time (aPTT) over time","Approximately up to week 9",{"measure":104,"description":57,"timeFrame":102},"Change from baseline in Prothrombin Time (PT)\u002FInternational Normalization Ratio (INR) over time",{"measure":106,"description":37,"timeFrame":54},"Total (first and subsequent) occurrences of expanded thrombotic vascular events",{"measure":108,"description":37,"timeFrame":54},"Time-to-first occurrence of a major thrombotic vascular event",{"measure":110,"description":37,"timeFrame":54},"Total (first and subsequent) occurrences of ALI, major amputation (above the ankle) of vascular etiology, MI, all-cause stroke, or CV death",{"measure":112,"description":37,"timeFrame":54},"Total (first and subsequent) occurrences of ALI, major amputation (above the ankle) of vascular etiology, MI, all-cause stroke, CV death, unplanned index limb revascularization, or VTE","ALL","18 Years",false,{"inclusion":117,"exclusion":118,"raw_text":119},[],[],"Key Inclusion Criteria:\n\n1. Successful LER distal to the external iliac artery for ischemia due to atherosclerotic disease within 10 days prior to randomization as described in the protocol\n2. At least 1 of the following enrichment factors for major thrombotic vascular events:\n\n   1. Bypass with prosthetic graft\n   2. Endovascular treatment with stenting\n   3. Target lesion length \\>15 cm\n   4. History of LER or amputation for PAD prior to qualifying LER\n   5. Type 2 diabetes mellitus requiring pharmacologic treatment\n   6. Comorbid symptomatic coronary artery disease as described in the protocol\n   7. Chronic kidney disease as described in the protocol\n   8. Age ≥75 years\n\nKey Exclusion Criteria:\n\n1. Has any active clinical condition requiring chronic therapeutic anticoagulation after the index revascularization including known triple positive antiphospholipid syndrome\n2. Has known bleeding diathesis, platelet count \\\u003C50,000\u002Fmm\\^3 or history of non-traumatic intracerebral hemorrhage, known cerebral amyloid angiopathy, or known unrepaired cerebrovascular malformations\n3. Has recent coronary revascularization as described in the protocol\n4. For Cohort 2 only: Has estimated Glomerular Filtration Rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73m\\^2 within 14 days prior to randomization or on dialysis or expected to be started on dialysis within the next 12 weeks starting from randomization\n5. Has any other condition or therapy which would make the participant unsuitable for this study or not allow participation for the full planned study period\n6. Has allergy, hypersensitivity, or other contraindication to REGN7508, REGN9933, or rivaroxaban (Cohort 2 only) or their excipients\n\nNote: Other Protocol Defined Inclusion\u002F Exclusion Criteria Apply",[121,122],"ADULT","OLDER_ADULT",[124,133,141,149,157,164,172,180,188,196,204,212,219,226,234,241,248],{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":129,"geoPoint":130},"Lake Martin Medical and Vascular Center","Alexander City","Alabama","35010","United States",{"lat":131,"lon":132},32.94401,-85.95385,{"facility":134,"status":8,"city":135,"state":136,"zip":137,"country":129,"geoPoint":138},"Axsendo Clinical Research, Integrated Medical Services","Avondale","Arizona","85392",{"lat":139,"lon":140},33.4356,-112.3496,{"facility":142,"status":8,"city":143,"state":144,"zip":145,"country":129,"geoPoint":146},"Applied Research Center of Arkansas","Little Rock","Arkansas","72205",{"lat":147,"lon":148},34.74648,-92.28959,{"facility":150,"status":8,"city":151,"state":152,"zip":153,"country":129,"geoPoint":154},"Angel City Research, Inc.","Los Angeles","California","90010",{"lat":155,"lon":156},34.05223,-118.24368,{"facility":158,"status":8,"city":159,"state":152,"zip":160,"country":129,"geoPoint":161},"Pacific Cardiovascular and Vein Institute","Oxnard","93036",{"lat":162,"lon":163},34.1975,-119.17705,{"facility":165,"status":8,"city":166,"state":167,"zip":168,"country":129,"geoPoint":169},"Nature Coast Clinical Research - Cardiology","Crystal River","Florida","34429",{"lat":170,"lon":171},28.90248,-82.5926,{"facility":173,"status":8,"city":174,"state":175,"zip":176,"country":129,"geoPoint":177},"Profound Research, Powers Health Medical Group","Munster","Indiana","46321",{"lat":178,"lon":179},41.56448,-87.51254,{"facility":181,"status":8,"city":182,"state":183,"zip":184,"country":129,"geoPoint":185},"Cardiovascular Solutions","Shreveport","Louisiana","71103",{"lat":186,"lon":187},32.52515,-93.75018,{"facility":189,"status":8,"city":190,"state":191,"zip":192,"country":129,"geoPoint":193},"Accellacare of Piedmont, Piedmont Healthcare","Mooresville","North Carolina","28117",{"lat":194,"lon":195},35.58486,-80.81007,{"facility":197,"status":8,"city":198,"state":199,"zip":200,"country":129,"geoPoint":201},"Hightower Clinical","Oklahoma City","Oklahoma","73102",{"lat":202,"lon":203},35.46756,-97.51643,{"facility":205,"status":8,"city":206,"state":207,"zip":208,"country":129,"geoPoint":209},"Apex Research Foundation, LLC","Jackson","Tennessee","38301",{"lat":210,"lon":211},35.61452,-88.81395,{"facility":213,"status":8,"city":214,"state":207,"zip":215,"country":129,"geoPoint":216},"Tennova TCMC","Knoxville","37934",{"lat":217,"lon":218},35.96064,-83.92074,{"facility":220,"status":8,"city":221,"state":207,"zip":222,"country":129,"geoPoint":223},"Vanderbilt Heart and Vascular Tullahoma, Cardiology and Vascular Associates","Tullahoma","37388",{"lat":224,"lon":225},35.36202,-86.20943,{"facility":227,"status":8,"city":228,"state":229,"zip":230,"country":129,"geoPoint":231},"PharmaTex Research","Amarillo","Texas","79106",{"lat":232,"lon":233},35.222,-101.8313,{"facility":235,"status":8,"city":236,"state":229,"zip":237,"country":129,"geoPoint":238},"Vital Heart and Vein","Cypress","77429",{"lat":239,"lon":240},29.96911,-95.69717,{"facility":242,"status":8,"city":243,"state":229,"zip":244,"country":129,"geoPoint":245},"Epic Medical Research","DeSoto","75115",{"lat":246,"lon":247},32.58986,-96.85695,{"facility":249,"status":8,"city":250,"state":229,"zip":251,"country":129,"geoPoint":252},"Epic Medical Research-Plano","Plano","75093",{"lat":253,"lon":254},33.01984,-96.69889,[256],{"name":257,"role":258,"phone":259,"email":260},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",[262],{"name":263,"affiliation":13,"role":264},"Clinical Trial Management","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":268,"biomarkers":270},[269],"Peripheral Artery Disease",[271],"Coagulation Factor XI",{"nct_id":4,"found":15,"summary":273,"prompt_version":17},{"design":274,"status":275,"heading":276,"summary":277,"follow_up":278,"word_count":279,"commitments":280,"compensation":281,"drugs_mentioned":282},"This is an interventional study with a planned enrollment of 7050 participants. It compares REGN7508, REGN9933, rivaroxaban, and a placebo.","completed","REGN7508 and REGN9933 for Peripheral Artery Disease","This study is looking into two experimental drugs, REGN7508 and REGN9933, for people with Peripheral Artery Disease (PAD). PAD means the blood vessels in your arms and legs are narrowed. If you have PAD and recently had a procedure to improve blood flow in your legs (Lower Extremity Revascularization or LER), you have a higher risk of blood clots. This study aims to see how well REGN7508 and REGN9933 prevent serious blood clots. The effects of these drugs will be compared to rivaroxaban, another medication, and a placebo (an inactive substance). The study will track how long it takes for participants to experience a major blood clot event or significant bleeding, for up to 42 months.","Participants will be followed for up to approximately 42 months to monitor for major blood clot events or significant bleeding.",116,"Not specified in the trial record.","Not stated in the trial record.",[33,41,46,49]]