RecruitingPhase 2NCT07175428

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)

Sponsor

Regeneron Pharmaceuticals

Enrollment

1,200 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)

Summary

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)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the real-world safety of blood thinners (anticoagulants) in adults who have atrial fibrillation (AFib) — an irregular heartbeat that increases the risk of stroke. The study tracks outcomes over time in people who are new to or already receiving anticoagulation therapy. **You may be eligible if...** - You have been diagnosed with atrial fibrillation or atrial flutter that is not caused by a reversible condition - You require indefinite blood thinner treatment based on your stroke risk score (CHA2DS2-VA score of 2 or higher) - You are either new to anticoagulant therapy or already established on it **You may NOT be eligible if...** - Your AFib is due to a short-term reversible cause - Your stroke risk score is below the threshold required for this study - You have conditions that make anticoagulation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGREGN7508

Administered per the protocol

DRUGREGN9933

Administered per the protocol

DRUGApixaban

Administered per the protocol

Locations(81)

SEC Clinical Research

Dothan, Alabama, United States

Eastern Shore Research Institute

Fairhope, Alabama, United States

Valley Clinical Trials, Inc

Covina, California, United States

North Coast Cardiology

Encinitas, California, United States

Mission Cardiovascular Research Institute

Fremont, California, United States

National Institute of California Heart and Vein Specialists

Huntington Beach, California, United States

Profound Research LLC at Southern California Heart Specialists

Pasadena, California, United States

Empire Clinical Research

Pomona, California, United States

The Cardiovascular Center

Redding, California, United States

Northbay Clinical Research Center

Santa Rosa, California, United States

Cardiology Associates Medical Group

Ventura, California, United States

Interventional Cardiology Medical Group

West Hills, California, United States

Nouvelle Clinical Research LLC

Cutler Bay, Florida, United States

South Florida Research Organization LLC

Medley, Florida, United States

Inpatient Research Clinic LLC

Miami Lakes, Florida, United States

Cardiovascular Center of Sarasota Foundation for Research and Education

Sarasota, Florida, United States

Clinical Site Partners, LLC DBA Flourish Research

Winter Park, Florida, United States

Grady Health System

Atlanta, Georgia, United States

Health Sciences Research Building II

Atlanta, Georgia, United States

NSC Research, Inc

Johns Creek, Georgia, United States

Indiana University

Indianapolis, Indiana, United States

Blue Coast Research Center, LLC

Indianapolis, Indiana, United States

Franciscan Physician Network, Indiana Heart Physicians

Indianapolis, Indiana, United States

Indiana Medical Research

Merrillville, Indiana, United States

Reid Physician Associates

Richmond, Indiana, United States

Monroe Research, LLC

West Monroe, Louisiana, United States

Anderson Medical Research

Ft. Washington, Maryland, United States

Beth Israel Lahey Health, Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, United States

Profound Research, Millennium Cardiology

Farmington Hills, Michigan, United States

AA Medical Research Center (MRC)

Flint, Michigan, United States

Fairview Health Services

Maplewood, Minnesota, United States

Moses Cone Hospital Operating Corporation dba Cone Health, Lebauer-Brodie Center for Cardiovascular Research

Greensboro, North Carolina, United States

K&R Research LLC

Marion, Ohio, United States

Advanced Medical Research

Maumee, Ohio, United States

Monument Health Clinical Research

Rapid City, South Dakota, United States

East Coast Institute for Research, Jefferson City

Jefferson City, Tennessee, United States

PharmaTex Research

Amarillo, Texas, United States

Complete Heart Care P.A.

McKinney, Texas, United States

Texas Institute of Cardiology PA

McKinney, Texas, United States

Synergy Group Medical, LLC

Missouri City, Texas, United States

Permian Research Foundation

Odessa, Texas, United States

Tyler Cardiovascular Consultants

Tyler, Texas, United States

Alpine Research TC

Clinton, Utah, United States

Centro de Investigacion Clinica

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Fundacion Estudios Clinicos

Rosario, Santa Fe Province, Argentina

STAT Research Argentina

Buenos Aires, Argentina

Sanatorio Duarte Quiros

Córdoba, Argentina

Centro de Investigaciones Clinicas del Litoral

Santa Fe, Argentina

Via Medica Research Center

Goiânia, Goiás, Brazil

Hospital Ruy Azeredo

Goiânia, Goiás, Brazil

Hospital das Clinicas da Universidade Federal de Goias

Goiânia, Goiás, Brazil

Cardiologia Assistencial e de Pesquisa Ltda (Cardresearch)

Belo Horizonte, Minas Gerais, Brazil

Nucleo de Pesquisa do Hospital Cardiologico Costantini (NUPEC)

Belo Horizonte, Minas Gerais, Brazil

Hospital Maternidade e Pronto Socorro Santa Lucia

Poços de Caldas, Minas Gerais, Brazil

Sociedade Hospitalar Angelina Caron

Campina Grande do Sul, Paraná, Brazil

Quanta Diagnostico por Imagem

Curitiba, Paraná, Brazil

Pontificia Universidade Catolica do Paraná (PUC) Trials

Curitiba, Paraná, Brazil

Nucleo de Pesquisa Clínica SS

Curitiba, Paraná, Brazil

Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul, Brazil

Centro de Estudos Procardio

Blumenau, Santa Catarina, Brazil

Instituto de Cardiologia de Santa Catarina

São José, Santa Catarina, Brazil

Centro De Pesquisa Clinica Do Coracao

Aracaju, Sergipe, Brazil

Faculdade de Medicina de Botucatu (UNESP)

Botucatu, São Paulo, Brazil

Instituto De Pesquisa Clinica de Campinas (Ipecc)

Campinas, São Paulo, Brazil

Hospital da Pontificia Universidade Catolica (PUC) Campinas

Campinas, São Paulo, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto, Centro Integrado de Pesquisa (CIP)

São José do Rio Preto, São Paulo, Brazil

Instituto Dante Pazanese de Cardiologia

São Paulo, Brazil

University of Alberta Hospital - Cardiology

Edmonton, Alberta, Canada

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, Canada

GA Research Associates Ltd.

Moncton, New Brunswick, Canada

Health sciences North - Cardiology

Greater Sudbury, Ontario, Canada

Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada

Hamilton Medical Research Group (HMRG)

Hamilton, Ontario, Canada

Dr James Cha

Oshawa, Ontario, Canada

Heart Health Institute Research Inc. - Cardiology

Scarborough Village, Ontario, Canada

Viacar Recherches Cliniques Inc. - Cardiologie

Longueuil, Quebec, Canada

CISSS du Bas-Saint-Laurent - Hopital regional de Rimouski - Cardiologie

Rimouski, Quebec, Canada

Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Cardiologie

Sherbrooke, Quebec, Canada

Diex Recherche Inc.

Sherbrooke, Quebec, Canada

Diex Recherche Trois-rivieres

Trois-Rivières, Quebec, Canada

CHU de Quebec-Universite Laval

Québec, Canada

View Full Details on ClinicalTrials.gov

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NCT07175428

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