Back to Trials
NCT07175428PHASE2Recruiting

Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation

Regeneron Pharmaceuticals

Start Date

10/20/2025

Completion Date

4/21/2027

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 Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: 1. 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 2. Meets one of the following: 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 2. CHA2DS2-VA score ≥3 or 3. CHA2DS2-VA score of 2 and at least 1 enrichment criteria as described in the protocol 3. Must have an International Normalization Ratio (INR) \<2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA) Key Exclusion Criteria: 1. Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion) 2. Has known moderate-to-severe mitral stenosis 3. Has had successful ablation therapy or Left Atrial Appendage (LAA) occlusion/exclusion, or planned ablation or LAA occlusion/exclusion as described in the protocol 4. Had an ischemic stroke within 2 days prior to randomization 5. 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 6. Has a history of central nervous system bleeding within 30 days prior to randomization Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Interventions

DRUG

REGN7508

DRUG

REGN9933

DRUG

Apixaban

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Atrial Fibrillation (AF)

Locations

SEC Clinical Research

Dothan, Alabama 36305

United States

Eastern Shore Research Institute

Fairhope, Alabama 36532

United States

Valley Clinical Trials, Inc

Covina, California 91723

United States

North Coast Cardiology

Encinitas, California 92024

United States

Mission Cardiovascular Research Institute

Fremont, California 94538

United States

National Institute of California Heart and Vein Specialists

Huntington Beach, California 92648

United States

Profound Research LLC at Southern California Heart Specialists

Pasadena, California 91105

United States

Empire Clinical Research

Pomona, California 91767

United States

Northbay Clinical Research Center

Santa Rosa, California 95405

United States

Cardiology Associates Medical Group

Ventura, California 93003

United States

Interventional Cardiology Medical Group

West Hills, California 91307

United States

Nouvelle Clinical Research LLC

Cutler Bay, Florida 33189

United States

South Florida Research Organization LLC

Medley, Florida 33166

United States

Inpatient Research Clinic LLC

Miami Lakes, Florida 33014

United States

Cardiovascular Center of Sarasota Foundation for Research and Education

Sarasota, Florida 34239

United States

Clinical Site Partners, LLC DBA Flourish Research

Winter Park, Florida 32789

United States

Grady Health System

Atlanta, Georgia 30303

United States

Health Sciences Research Building II

Atlanta, Georgia 30322

United States

NSC Research, Inc

Johns Creek, Georgia 30024

United States

Indiana University

Indianapolis, Indiana 46202

United States

Blue Coast Research Center, LLC

Indianapolis, Indiana 46237

United States

Franciscan Physician Network, Indiana Heart Physicians

Indianapolis, Indiana 46237

United States

Indiana Medical Research

Merrillville, Indiana 46410

United States

Reid Physician Associates

Richmond, Indiana 47374

United States

Monroe Research, LLC

West Monroe, Louisiana 71291

United States

Anderson Medical Research

Ft. Washington, Maryland 20744

United States

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

Boston, Massachusetts 02215

United States

Profound Research, Millennium Cardiology

Farmington Hills, Michigan 48334

United States

AA Medical Research Center (MRC)

Flint, Michigan 48504

United States

Fairview Health Services

Maplewood, Minnesota 55109

United States

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

Greensboro, North Carolina 27401

United States

K&R Research LLC

Marion, Ohio 43302

United States

Advanced Medical Research

Maumee, Ohio 43537

United States

Monument Health Clinical Research

Rapid City, South Dakota 57701

United States

East Coast Institute for Research, Jefferson City

Jefferson City, Tennessee 37760

United States

PharmaTex Research

Amarillo, Texas 79106

United States

Complete Heart Care P.A.

McKinney, Texas 75071

United States

Permian Research Foundation

Odessa, Texas 79761

United States

Tyler Cardiovascular Consultants

Tyler, Texas 75701

United States

Alpine Research TC

Clinton, Utah 84015

United States

Fundacion Estudios Clinicos - Cardiologia

Rosario, Santa Fe Province 2000

Argentina

STAT Research Argentina

Buenos Aires, 1060

Argentina

Centro de Investigaciones Clinicas del Litoral - Cardiologia

Santa Fe, S3000FWO

Argentina

Hospital Ruy Azeredo

Goiânia, Goiás 74453-200

Brazil

Cardiologia Assistencial e de Pesquisa Ltda (Cardresearch)

Belo Horizonte, Minas Gerais 30150-274

Brazil

Nucleo de Pesquisa do Hospital Cardiologico Costantini (NUPEC)

Belo Horizonte, Minas Gerais 30220-140

Brazil

Hospital Maternidade e Pronto Socorro Santa Lucia

Poços de Caldas, Minas Gerais 37706-106

Brazil

Sociedade Hospitalar Angelina Caron

Campina Grande do Sul, Paraná 83430-973

Brazil

Pontificia Universidade Catolica do Paraná (PUC) Trials

Curitiba, Paraná 80230-130

Brazil

Nucleo de Pesquisa Clínica SS

Curitiba, Paraná 80730-150

Brazil

Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul 90160-092

Brazil

Instituto de Cardiologia de Santa Catarina

São José, Santa Catarina 88103-450

Brazil

Centro De Pesquisa Clinica Do Coracao

Aracaju, Sergipe 49055-530

Brazil

Faculdade de Medicina de Botucatu (UNESP)

Botucatu, São Paulo 18618-687

Brazil

Instituto De Pesquisa Clinica de Campinas (Ipecc)

Campinas, São Paulo 13060-080

Brazil

Hospital da Pontificia Universidade Catolica (PUC) Campinas

Campinas, São Paulo 13060-904

Brazil

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

São José do Rio Preto, São Paulo 15090-000

Brazil

University of Alberta Hospital - Cardiology

Edmonton, Alberta T6G 2G3

Canada

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia V8Z 0B9

Canada

GA Research Associates Ltd.

Moncton, New Brunswick E1G-1A7

Canada

Health sciences North - Cardiology

Greater Sudbury, Ontario P3E 5J1

Canada

Hamilton Health Sciences Corporation

Hamilton, Ontario L8L 2X2

Canada

Hamilton Medical Research Group (HMRG)

Hamilton, Ontario L8L 5G4

Canada

Dr James Cha

Oshawa, Ontario L1J 2K1

Canada

Heart Health Institute Research Inc. - Cardiology

Scarborough Village, Ontario M1B 4Z8

Canada

Viacar Recherches Cliniques Inc. - Cardiologie

Longueuil, Quebec J4H 4B9

Canada

Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Cardiologie

Sherbrooke, Quebec J1H 5N4

Canada

Diex Recherche Inc.

Sherbrooke, Quebec J1LOK3

Canada

Diex Recherche Trois-rivieres

Trois-Rivières, Quebec G9A 4P3

Canada

CHU de Quebec-Universite Laval

Québec, G1R 2J6

Canada