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NCT07175428RecruitingPhase 2

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)

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

Brief summary (registry, in English)

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. The 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. The study is looking at several other research questions, including: * What side effects may happen from taking REGN7508 or REGN9933 * How well do the study drugs reduce the risk of having a stroke * How much of REGN7508 or REGN9933 is in the blood at different times * Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the drugs less effective or could lead to side effects)

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
1200 (estimated)
First submitted
9 Sept 2025
Start date
20 Oct 2025
Primary completion date
9 Feb 2027
Lead sponsor
Regeneron Pharmaceuticals
NCT number
NCT07175428

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 1200
  • From 20 Oct 2025 to the primary completion date, 9 Feb 2027
  • 91 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has had successful ablation therapy or Left Atrial Appendage (LAA) occlusion/exclusion, or planned ablation or LAA occlusion/exclusion as described in the protocol
  • Had an ischemic stroke within 2 days prior to randomization
  • Has a history of central nervous system bleeding within 30 days prior to randomization
    • Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Other illness

  • Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)

Lab values

  • Has estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73m\^2 within 30 days prior to randomization or on dialysis or expected to be started as described in the protocol

Other

  • Has known moderate-to-severe mitral stenosis

Who the study is looking for

  • 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
  • Meets one of the following:
    • 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
    • CHA2DS2-VA score ≥3 or
    • CHA2DS2-VA score of 2 and at least 1 enrichment criteria as described in the protocol
  • Must have an International Normalization Ratio (INR) \<2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (91)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
STAT Research Argentina
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Buenos AiresArgentinaRecruiting
Centro de Investigacion Clinica
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Ciudad Autonoma de Buenos AiresArgentinaRecruiting
Sanatorio Duarte Quiros
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CórdobaArgentinaRecruiting
DIM Clínica Privada
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Ramos MejíaArgentinaRecruiting
Fundacion Estudios Clinicos
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RosarioArgentinaRecruiting
Sanatorio Parque
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RosarioArgentinaRecruiting
Centro de Investigaciones Clinicas del Litoral
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Santa FeArgentinaRecruiting
Centro de Investigaciones Medicas Temperley (CIMeT)
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TemperleyArgentinaRecruiting
Centro de Pesquisa Clinica do Coracao
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AracajuBrazilRecruiting
Nucleo de Pesquisa do Hospital Cardiologico Costantini (NUPEC)
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Belo HorizonteBrazilRecruiting
Cardiologia Assistencial e de Pesquisa Ltda (Cardresearch)
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Belo HorizonteBrazilRecruiting
Centro de Estudos Procardio
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BlumenauBrazilRecruiting
AngioKormann Blumenau
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BlumenauBrazilRecruiting
Faculdade de Medicina de Botucatu (UNESP)
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BotucatuBrazilRecruiting
Hospital Universitário São Francisco na Providência de Deus
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Bragança PaulistaBrazilRecruiting
Sociedade Hospitalar Angelina Caron
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Campina Grande do SulBrazilRecruiting
Instituto De Pesquisa Clinica de Campinas (Ipecc)
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CampinasBrazilRecruiting
Hospital da Pontificia Universidade Catolica (PUC) Campinas
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CampinasBrazilRecruiting
Pontificia Universidade Catolica do Paraná (PUC) Trials
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CuritibaBrazilRecruiting
Quanta Diagnostico por Imagem
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CuritibaBrazilRecruiting
Nucleo de Pesquisa Clínica SS
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CuritibaBrazilRecruiting
Hospital Ruy Azeredo
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GoiâniaBrazilRecruiting
Hospital das Clinicas da Universidade Federal de Goias
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GoiâniaBrazilRecruiting
Via Medica Research Center
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GoiâniaBrazilRecruiting
Hospital Maternidade e Pronto Socorro Santa Lucia
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Poços de CaldasBrazilRecruiting
Hospital Ernesto Dornelles
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Porto AlegreBrazilRecruiting
CoraCentro Pesquisa Clinica
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Porto AlegreBrazilRecruiting
CLINICOR - Clinica Cardiologica Ltda
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Ribeirão PretoBrazilRecruiting
Instituto de Cardiologia de Santa Catarina
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São JoséBrazilRecruiting
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto, Centro Integrado de Pesquisa (CIP)
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São José do Rio PretoBrazilRecruiting
Instituto Dante Pazanese de Cardiologia
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São PauloBrazilRecruiting
Eurolatino Medical Research
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UberlândiaBrazilRecruiting
University of Alberta Hospital - Cardiology
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EdmontonCanadaRecruiting
Health sciences North - Cardiology
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Greater SudburyCanadaRecruiting
Hamilton Medical Research Group (HMRG)
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HamiltonCanadaRecruiting
Hamilton Health Sciences Corporation
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HamiltonCanadaRecruiting
Viacar Recherches Cliniques Inc. - Cardiologie
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LongueuilCanadaRecruiting
GA Research Associates Ltd.
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MonctonCanadaRecruiting
Montreal Heart Institute
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MontrealCanadaRecruiting
Dr James Cha
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OshawaCanadaRecruiting
CHU de Quebec-Universite Laval
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QuébecCanadaRecruiting
CISSS du Bas-Saint-Laurent - Hopital regional de Rimouski - Cardiologie
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RimouskiCanadaRecruiting
Heart Health Institute Research Inc. - Cardiology
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Scarborough VillageCanadaRecruiting
Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Cardiologie
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SherbrookeCanadaRecruiting
Diex Recherche Inc.
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SherbrookeCanadaRecruiting
CISSSLAN, Hopital Pierre-Le Gardeur
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TerrebonneCanadaRecruiting
Diex Recherche Trois-Rivieres
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Trois-RivièresCanadaRecruiting
Victoria Cardiac Arrhythmia Trials
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VictoriaCanadaRecruiting
PharmaTex Research
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AmarilloUnited StatesRecruiting
Grady Health System
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AtlantaUnited StatesRecruiting
Health Sciences Research Building II
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AtlantaUnited StatesWithdrawn
Beth Israel Lahey Health-Beth Israel Deaconess Medical Center (BIDMC)
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BostonUnited StatesRecruiting
Alpine Research TC
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ClintonUnited StatesRecruiting
Valley Clinical Trials, Inc.
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CovinaUnited StatesRecruiting
Nouvelle Clinical Research LLC
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Cutler BayUnited StatesRecruiting
SEC Clinical Research
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DothanUnited StatesRecruiting
North Coast Cardiology
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EncinitasUnited StatesRecruiting
Eastern Shore Research Institute
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FairhopeUnited StatesRecruiting
Profound Research, Millennium Cardiology
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Farmington HillsUnited StatesRecruiting
AA Medical Research Center (MRC)
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FlintUnited StatesRecruiting
Mission Cardiovascular Research Institute
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FremontUnited StatesRecruiting
Anderson Medical Research
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Ft. WashingtonUnited StatesRecruiting
Moses Cone Hospital Operating Corporation dba Cone Health, Lebauer-Brodie Center for Cardiovascular Research
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GreensboroUnited StatesRecruiting
National Institute of California Heart and Vein Specialists
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Huntington BeachUnited StatesRecruiting
Indiana University
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IndianapolisUnited StatesRecruiting
Franciscan Physician Network, Indiana Heart Physicians
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IndianapolisUnited StatesRecruiting
Blue Coast Research Center, LLC
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IndianapolisUnited StatesRecruiting
East Coast Institute for Research, Jefferson City
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Jefferson CityUnited StatesRecruiting
NSC Research, Inc
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Johns CreekUnited StatesRecruiting
Fairview Health Services
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MaplewoodUnited StatesRecruiting
K&R Research LLC
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MarionUnited StatesRecruiting
Advanced Medical Research
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MaumeeUnited StatesRecruiting
Texas Institute of Cardiology PA
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McKinneyUnited StatesRecruiting
Complete Heart Care P.A.
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McKinneyUnited StatesRecruiting
South Florida Research Organization LLC
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MedleyUnited StatesRecruiting
Indiana Medical Research
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MerrillvilleUnited StatesRecruiting
Inpatient Research Clinic LLC
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Miami LakesUnited StatesRecruiting
Synergy Group Medical, LLC
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Missouri CityUnited StatesRecruiting
Permian Research Foundation
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OdessaUnited StatesRecruiting
Profound Research LLC at Southern California Heart Specialists
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PasadenaUnited StatesRecruiting
Empire Clinical Research
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PomonaUnited StatesRecruiting
Monument Health Clinical Research
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Rapid CityUnited StatesRecruiting
The Cardiovascular Center
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ReddingUnited StatesRecruiting
Reid Physician Associates
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RichmondUnited StatesRecruiting
Northbay Clinical Research Center
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Santa RosaUnited StatesRecruiting
Cardiovascular Center of Sarasota Foundation for Research and Education
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SarasotaUnited StatesRecruiting
Tyler Cardiovascular Consultants
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TylerUnited StatesRecruiting
Cardiology Associates Medical Group
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VenturaUnited StatesRecruiting
Interventional Cardiology Medical Group
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West HillsUnited StatesRecruiting
Monroe Research, LLC
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West MonroeUnited StatesRecruiting
Clinical Site Partners, LLC dba Flourish Research
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Winter ParkUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.