[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07175428":3,"trial-entities:NCT07175428":675,"trial-summary:NCT07175428":679},{"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":50,"secondary_outcomes":55,"sex":94,"minimum_age":95,"maximum_age":17,"healthy_volunteers":96,"eligibility_criteria":97,"std_ages":101,"locations":104,"central_contacts":663,"overall_officials":669,"references":673,"see_also_links":674},"NCT07175428","R7508-CVA-2393","Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation","A Phase 2, Randomized, Multicenter, Open-label, Blinded-endpoint Study to Evaluate the Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against FXI, Versus Apixaban in Participants With Atrial Fibrillation (ROXI-ATLAS)","RECRUITING","2027-04-21","2026-09","2026-09-15","2025-10-20","Regeneron Pharmaceuticals","INDUSTRY",true,"This study is researching experimental drugs called REGN7508 and REGN9933. The study is focused on participants who have atrial fibrillation, which means that the heart beats too fast and unevenly. REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation.\n\nThe aim of the study is to see how well REGN7508 and REGN9933 work in patients that get medicine for their atrial fibrillation. The bleeding effects of REGN7508 and REGN9933 will be compared to another medicine (apixaban), which is available on the market to treat and prevent formation of blood clots.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking REGN7508 or REGN9933\n* How well do the study drugs reduce the risk of having a stroke\n* How much of REGN7508 or REGN9933 is in the blood at different times\n* Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the drugs less effective or could lead to side effects)",null,[19],"Atrial Fibrillation (AF)",[21,22,23,24],"Bleeding","Stroke","Systemic embolism","Blood clots","INTERVENTIONAL","PREVENTION",[28],"PHASE2",{"count":30,"type":31},1200,"ESTIMATED",[33,40,45],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","REGN7508","Administered per the protocol",[35],[39],"cenvacibart",{"type":34,"name":41,"description":36,"armGroupLabels":42,"otherNames":43},"REGN9933",[41],[44],"amrecibart",{"type":34,"name":46,"description":36,"armGroupLabels":47,"otherNames":48},"Apixaban",[46],[49],"Eliquis",[51],{"measure":52,"description":53,"timeFrame":54},"Incidence of any bleeding","Defined as the composite of International Society on Thrombosis and Haemostasis (ISTH) major bleeding, ISTH Clinically Relevant Non-Major (CRNM) bleeding, or minor bleeding","12 weeks",[56,58,60,62,64,66,68,70,73,75,78,80,82,84,86,88,90,92],{"measure":57,"timeFrame":54},"Incidence of the composite of ISTH major bleeding or ISTH CRNM bleeding",{"measure":59,"timeFrame":54},"Incidence of ISTH major bleeding",{"measure":61,"timeFrame":54},"Incidence of ISTH CRNM bleeding",{"measure":63,"timeFrame":54},"Incidence of minor bleeding",{"measure":65,"timeFrame":54},"Number of ISTH major bleeding events",{"measure":67,"timeFrame":54},"Number of ISTH CRNM bleeding events",{"measure":69,"timeFrame":54},"Number of minor bleeding events",{"measure":71,"timeFrame":72},"Incidence of Treatment-Emergent Adverse Events (TEAEs)","Approximately 25 weeks",{"measure":74,"timeFrame":72},"Severity of TEAEs",{"measure":76,"timeFrame":77},"Incidence of the composite of stroke or systemic embolism","Approximately 12 weeks",{"measure":79,"timeFrame":54},"Incidence of Antidrug Antibodies (ADA) to REGN7508",{"measure":81,"timeFrame":54},"Magnitude of ADA to REGN7508",{"measure":83,"timeFrame":54},"Incidence of ADA to REGN9933",{"measure":85,"timeFrame":54},"Magnitude of ADA to REGN9933",{"measure":87,"timeFrame":72},"Concentrations of REGN7508",{"measure":89,"timeFrame":72},"Concentrations of REGN9933",{"measure":91,"timeFrame":72},"Change from baseline in activated Partial Thromboplastin Time (aPTT)",{"measure":93,"timeFrame":72},"Change from baseline in Prothrombin Time (PT)","ALL","18 Years",false,{"inclusion":98,"exclusion":99,"raw_text":100},[],[],"Key Inclusion Criteria:\n\n1. Has AF or flutter (paroxysmal or persistent), not felt to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol\n2. Meets one of the following:\n\n   1. CHA2DS2-VA \\[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Thromboembolism (double points); V: Vascular disease; A: Age 65-74 years\\] score ≥2 and Oral Anticoagulant (OAC) naïve or\n   2. CHA2DS2-VA score ≥3 or\n   3. CHA2DS2-VA score of 2 and at least 1 enrichment criteria as described in the protocol\n3. Must have an International Normalization Ratio (INR) \\\u003C2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)\n\nKey Exclusion Criteria:\n\n1. Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)\n2. Has known moderate-to-severe mitral stenosis\n3. Has had successful ablation therapy or Left Atrial Appendage (LAA) occlusion\u002Fexclusion, or planned ablation or LAA occlusion\u002Fexclusion as described in the protocol\n4. Had an ischemic stroke within 2 days prior to randomization\n5. Has estimated Glomerular Filtration Rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73m\\^2 within 30 days prior to randomization or on dialysis or expected to be started as described in the protocol\n6. Has a history of central nervous system bleeding within 30 days prior to randomization\n\nNote: Other protocol-defined Inclusion\u002F Exclusion criteria apply",[102,103],"ADULT","OLDER_ADULT",[105,114,121,129,136,143,150,157,164,171,178,185,192,200,207,214,221,228,236,241,248,256,260,263,270,277,285,293,301,309,316,324,332,340,347,355,363,371,378,381,388,395,402,410,416,424,429,436,443,452,456,460,468,472,479,487,494,498,502,510,518,525,533,541,548,552,559,565,574,582,590,598,605,609,616,623,631,638,645,649,656],{"facility":106,"status":8,"city":107,"state":108,"zip":109,"country":110,"geoPoint":111},"SEC Clinical Research","Dothan","Alabama","36305","United States",{"lat":112,"lon":113},31.22323,-85.39049,{"facility":115,"status":8,"city":116,"state":108,"zip":117,"country":110,"geoPoint":118},"Eastern Shore Research Institute","Fairhope","36532",{"lat":119,"lon":120},30.52297,-87.90333,{"facility":122,"status":8,"city":123,"state":124,"zip":125,"country":110,"geoPoint":126},"Valley 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Washington","Maryland","20744",{"lat":291,"lon":292},38.70734,-77.02303,{"facility":294,"status":8,"city":295,"state":296,"zip":297,"country":110,"geoPoint":298},"Beth Israel Lahey Health, Beth Israel Deaconess Medical Center (BIDMC)","Boston","Massachusetts","02215",{"lat":299,"lon":300},42.35843,-71.05977,{"facility":302,"status":8,"city":303,"state":304,"zip":305,"country":110,"geoPoint":306},"Profound Research, Millennium Cardiology","Farmington Hills","Michigan","48334",{"lat":307,"lon":308},42.48531,-83.37716,{"facility":310,"status":8,"city":311,"state":304,"zip":312,"country":110,"geoPoint":313},"AA Medical Research Center (MRC)","Flint","48504",{"lat":314,"lon":315},43.01253,-83.68746,{"facility":317,"status":8,"city":318,"state":319,"zip":320,"country":110,"geoPoint":321},"Fairview Health Services","Maplewood","Minnesota","55109",{"lat":322,"lon":323},44.95302,-92.99522,{"facility":325,"status":8,"city":326,"state":327,"zip":328,"country":110,"geoPoint":329},"Moses Cone Hospital Operating Corporation dba Cone Health, Lebauer-Brodie Center for Cardiovascular Research","Greensboro","North Carolina","27401",{"lat":330,"lon":331},36.07264,-79.79198,{"facility":333,"status":8,"city":334,"state":335,"zip":336,"country":110,"geoPoint":337},"K&R Research LLC","Marion","Ohio","43302",{"lat":338,"lon":339},40.58867,-83.12852,{"facility":341,"status":8,"city":342,"state":335,"zip":343,"country":110,"geoPoint":344},"Advanced Medical Research","Maumee","43537",{"lat":345,"lon":346},41.56283,-83.65382,{"facility":348,"status":8,"city":349,"state":350,"zip":351,"country":110,"geoPoint":352},"Monument Health Clinical Research","Rapid City","South Dakota","57701",{"lat":353,"lon":354},44.08054,-103.23101,{"facility":356,"status":8,"city":357,"state":358,"zip":359,"country":110,"geoPoint":360},"East Coast Institute for Research, Jefferson City","Jefferson 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Sao Jose do Rio Preto, Centro Integrado de Pesquisa (CIP)","São José do Rio Preto","15090-000",{"lat":557,"lon":558},-20.81972,-49.37944,{"facility":560,"status":8,"city":536,"zip":561,"country":448,"geoPoint":562},"Instituto Dante Pazanese de Cardiologia","04012-909",{"lat":563,"lon":564},-23.5475,-46.63611,{"facility":566,"status":8,"city":567,"state":568,"zip":569,"country":570,"geoPoint":571},"University of Alberta Hospital - Cardiology","Edmonton","Alberta","T6G 2G3","Canada",{"lat":572,"lon":573},53.55014,-113.46871,{"facility":575,"status":8,"city":576,"state":577,"zip":578,"country":570,"geoPoint":579},"Victoria Cardiac Arrhythmia Trials","Victoria","British Columbia","V8Z 0B9",{"lat":580,"lon":581},48.4359,-123.35155,{"facility":583,"status":8,"city":584,"state":585,"zip":586,"country":570,"geoPoint":587},"GA Research Associates Ltd.","Moncton","New 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4Z8",{"lat":621,"lon":622},43.73899,-79.22124,{"facility":624,"status":8,"city":625,"state":626,"zip":627,"country":570,"geoPoint":628},"Viacar Recherches Cliniques Inc. - Cardiologie","Longueuil","Quebec","J4H 4B9",{"lat":629,"lon":630},45.5152,-73.46818,{"facility":632,"status":8,"city":633,"state":626,"zip":634,"country":570,"geoPoint":635},"CISSS du Bas-Saint-Laurent - Hopital regional de Rimouski - Cardiologie","Rimouski","G5L 5T1",{"lat":636,"lon":637},48.44879,-68.52396,{"facility":639,"status":8,"city":640,"state":626,"zip":641,"country":570,"geoPoint":642},"Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Cardiologie","Sherbrooke","J1H 5N4",{"lat":643,"lon":644},45.40008,-71.89908,{"facility":646,"status":8,"city":640,"state":626,"zip":647,"country":570,"geoPoint":648},"Diex Recherche Inc.","J1LOK3",{"lat":643,"lon":644},{"facility":650,"status":8,"city":651,"state":626,"zip":652,"country":570,"geoPoint":653},"Diex Recherche Trois-rivieres","Trois-Rivières","G9A 4P3",{"lat":654,"lon":655},46.34515,-72.5477,{"facility":657,"status":8,"city":658,"zip":659,"country":570,"geoPoint":660},"CHU de Quebec-Universite Laval","Québec","G1R 2J6",{"lat":661,"lon":662},46.81228,-71.21454,[664],{"name":665,"role":666,"phone":667,"email":668},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",[670],{"name":671,"affiliation":13,"role":672},"Clinical Trial Management","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":676,"biomarkers":678},[677],"Atrial Fibrillation",[],{"nct_id":4,"found":15,"summary":680,"prompt_version":17},{"design":681,"status":682,"heading":683,"summary":684,"follow_up":685,"word_count":686,"commitments":687,"compensation":688,"drugs_mentioned":689},"This is an interventional study involving approximately 1200 participants. It compares the effects of REGN7508 and REGN9933 with apixaban.","completed","Safety of REGN7508 and REGN9933 for Atrial Fibrillation","This study is looking at two experimental drugs, REGN7508 and REGN9933, for adults with atrial fibrillation (AF), a condition where the heart beats too fast and unevenly. These drugs are designed to help prevent blood clots. The study aims to compare the bleeding effects of REGN7508 and REGN9933 to a commonly used medication called apixaban. You may be able to join if you are an adult with AF or flutter (a similar heart rhythm problem) and need ongoing blood clot prevention. The main goal is to see how often any bleeding occurs in participants over 12 weeks. The study is currently recruiting about 1200 participants.","The primary endpoint measures bleeding incidence at 12 weeks.",105,"Not specified in the trial record.","Not stated in the trial record.",[35,41,46]]