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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)

Status: Recruiting
Location: See all (77) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Alabama
SEC Clinical Research
RECRUITING
Dothan
Eastern Shore Research Institute
RECRUITING
Fairhope
California
Valley Clinical Trials, Inc
RECRUITING
Covina
North Coast Cardiology
RECRUITING
Encinitas
Mission Cardiovascular Research Institute
RECRUITING
Fremont
National Institute of California Heart and Vein Specialists
RECRUITING
Huntington Beach
Profound Research LLC at Southern California Heart Specialists
RECRUITING
Pasadena
Empire Clinical Research
RECRUITING
Pomona
The Cardiovascular Center
RECRUITING
Redding
Northbay Clinical Research Center
RECRUITING
Santa Rosa
Cardiology Associates Medical Group
RECRUITING
Ventura
Interventional Cardiology Medical Group
RECRUITING
West Hills
Florida
Nouvelle Clinical Research LLC
RECRUITING
Cutler Bay
South Florida Research Organization LLC
RECRUITING
Medley
Inpatient Research Clinic LLC
RECRUITING
Miami Lakes
Cardiovascular Center of Sarasota Foundation for Research and Education
RECRUITING
Sarasota
Clinical Site Partners, LLC DBA Flourish Research
RECRUITING
Winter Park
Georgia
Grady Health System
RECRUITING
Atlanta
Health Sciences Research Building II
WITHDRAWN
Atlanta
NSC Research, Inc
RECRUITING
Johns Creek
Indiana
Blue Coast Research Center, LLC
RECRUITING
Indianapolis
Franciscan Physician Network, Indiana Heart Physicians
RECRUITING
Indianapolis
Indiana University
RECRUITING
Indianapolis
Indiana Medical Research
RECRUITING
Merrillville
Reid Physician Associates
RECRUITING
Richmond
Louisiana
Monroe Research, LLC
RECRUITING
West Monroe
Massachusetts
Beth Israel Lahey Health, Beth Israel Deaconess Medical Center (BIDMC)
RECRUITING
Boston
Maryland
Anderson Medical Research
RECRUITING
Ft. Washington
Michigan
Profound Research, Millennium Cardiology
RECRUITING
Farmington Hills
AA Medical Research Center (MRC)
RECRUITING
Flint
Minnesota
Fairview Health Services
RECRUITING
Maplewood
North Carolina
Moses Cone Hospital Operating Corporation dba Cone Health, Lebauer-Brodie Center for Cardiovascular Research
RECRUITING
Greensboro
Ohio
K&R Research LLC
RECRUITING
Marion
Advanced Medical Research
RECRUITING
Maumee
South Dakota
Monument Health Clinical Research
RECRUITING
Rapid City
Tennessee
East Coast Institute for Research, Jefferson City
RECRUITING
Jefferson City
Texas
PharmaTex Research
RECRUITING
Amarillo
Complete Heart Care P.A.
RECRUITING
Mckinney
Texas Institute of Cardiology PA
RECRUITING
Mckinney
Synergy Group Medical, LLC
RECRUITING
Missouri City
Permian Research Foundation
RECRUITING
Odessa
Tyler Cardiovascular Consultants
RECRUITING
Tyler
Utah
Alpine Research TC
RECRUITING
Clinton
Other Locations
Argentina
STAT Research Argentina
RECRUITING
Buenos Aires
Centro de Investigacion Clinica
RECRUITING
Ciudad Autonoma De Buenos Aires
Fundacion Estudios Clinicos
RECRUITING
Rosario
Centro de Investigaciones Clinicas del Litoral
RECRUITING
Santa Fe
Brazil
Centro De Pesquisa Clinica Do Coracao
RECRUITING
Aracaju
Cardiologia Assistencial e de Pesquisa Ltda (Cardresearch)
RECRUITING
Belo Horizonte
Nucleo de Pesquisa do Hospital Cardiologico Costantini (NUPEC)
RECRUITING
Belo Horizonte
Faculdade de Medicina de Botucatu (UNESP)
RECRUITING
Botucatu
Sociedade Hospitalar Angelina Caron
RECRUITING
Campina Grande Do Sul
Hospital da Pontificia Universidade Catolica (PUC) Campinas
RECRUITING
Campinas
Instituto De Pesquisa Clinica de Campinas (Ipecc)
RECRUITING
Campinas
Nucleo de Pesquisa Clínica SS
RECRUITING
Curitiba
Pontificia Universidade Catolica do Paraná (PUC) Trials
RECRUITING
Curitiba
Quanta Diagnostico por Imagem
RECRUITING
Curitiba
Hospital das Clinicas da Universidade Federal de Goias
RECRUITING
Goiânia
Hospital Ruy Azeredo
RECRUITING
Goiânia
Hospital Maternidade e Pronto Socorro Santa Lucia
RECRUITING
Poços De Caldas
Hospital Ernesto Dornelles
RECRUITING
Porto Alegre
Instituto de Cardiologia de Santa Catarina
RECRUITING
São José
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto, Centro Integrado de Pesquisa (CIP)
RECRUITING
São José Do Rio Preto
Instituto Dante Pazanese de Cardiologia
RECRUITING
São Paulo
Canada
University of Alberta Hospital - Cardiology
RECRUITING
Edmonton
Health sciences North - Cardiology
RECRUITING
Greater Sudbury
Hamilton Health Sciences Corporation
RECRUITING
Hamilton
Hamilton Medical Research Group (HMRG)
RECRUITING
Hamilton
Viacar Recherches Cliniques Inc. - Cardiologie
RECRUITING
Longueuil
GA Research Associates Ltd.
RECRUITING
Moncton
Dr James Cha
RECRUITING
Oshawa
CHU de Quebec-Universite Laval
RECRUITING
Québec
Heart Health Institute Research Inc. - Cardiology
RECRUITING
Scarborough Village
Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Cardiologie
RECRUITING
Sherbrooke
Diex Recherche Inc.
RECRUITING
Sherbrooke
Diex Recherche Trois-rivieres
RECRUITING
Trois-rivières
Victoria Cardiac Arrhythmia Trials
RECRUITING
Victoria
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2025-10-20
Estimated Completion Date: 2027-04-21
Participants
Target number of participants: 1200
Treatments
Experimental: REGN7508
Experimental: REGN9933
Active_comparator: Apixaban
Related Therapeutic Areas
Stroke
Atrial Fibrillation
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov

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