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RECRUITING
NCT07175428
PHASE2

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

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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)

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2025-10-20

Completion Date

2027-04-21

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

REGN7508

Administered per the protocol

DRUG

REGN9933

Administered per the protocol

DRUG

Apixaban

Administered per the protocol

Locations (41)

SEC Clinical Research

Dothan, Alabama, United States

Eastern Shore Research Institute

Fairhope, Alabama, 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

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

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

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 Deaconess Medical Center

Boston, Massachusetts, United States

Profound Research LLC

Farmington Hills, Michigan, United States

AA Medical Research Center (MRC)

Flint, Michigan, 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

Permian Research Foundation

Odessa, Texas, United States

Tyler Cardiovascular Consultants

Tyler, Texas, United States

Alpine Research TC

Clinton, Utah, United States

GA Research Associates Ltd.

Moncton, New Brunswick, Canada

Health sciences North - Cardiology

Greater Sudbury, 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

Diex Recherche Inc.

Sherbrooke, Quebec, Canada

Diex Recherche Trois-rivieres

Trois-Rivières, Quebec, Canada