RecruitingPhase 3NCT07626411

Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation

A Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention With REGN7508, a Monoclonal Antibody Against Factor XI, Versus Apixaban in Participants With Atrial Fibrillation (ROXI-EVEREST)


Sponsor

Regeneron Pharmaceuticals

Enrollment

15,364 participants

Start Date

Aug 10, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called apixaban. The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. The aim of the study is to see how safe and effective REGN7508 is in preventing stroke and/or systemic embolism in participants with atrial fibrillation and how it compares against participants that will receive apixaban in this study. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Apixaban, a drug called Placebo, and others for people with atrial fibrillation (af). The study is currently recruiting participants at 8 locations.

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

DRUGApixaban

Administered per the protocol

DRUGPlacebo

Administered per the protocol


Locations(32)

Advanced Cardiovascular

Alexander City, Alabama, United States

SEC Clinical Research

Dothan, Alabama, United States

Sun City Clinical Research

Glendale, Arizona, United States

Mission Cardiovascular Research Institute

Fremont, California, United States

Profound Research LLC at San Diego Cardiovascular Associates

La Jolla, California, United States

Radin Cardiovascular Medical Group

Newport Beach, California, United States

Valley Clinical Trials, LLC dba Flourish Research

Northridge, California, United States

Southern California Heart Specialists

Pasadena, 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

Sec Clinical Research

Pensacola, Florida, United States

Cardiovascular Center of Sarasota Foundation for Research and Education

Sarasota, Florida, United States

Atlanta Clinical Research Centers

Atlanta, Georgia, United States

NSC Research, Inc

Johns Creek, Georgia, United States

Profound Research, Powers Health Medical Group - Electrophysiology

Munster, Indiana, United States

Monroe Research, LLC

West Monroe, Louisiana, United States

Anderson Medical Research

Ft. Washington, Maryland, United States

Profound Research, Cardiology and Vascular Associates (CAVA) - Bloomfield Hills

Bloomfield Hills, Michigan, United States

Profound Research, Millennium Cardiology

Farmington Hills, Michigan, United States

Super Health Pharmacy

Staten Island, New York, United States

Hawthorne Health, Moose Pharmacy of Concord

Concord, North Carolina, United States

K&R Research LLC

Marion, Ohio, United States

Tennessee Center for Clinical Trials

Tullahoma, Tennessee, United States

PharmaTex Research

Amarillo, Texas, United States

PanAmerican Clinical Research

Brownsville, Texas, United States

Synergy Groups Medical

Houston, Texas, United States

West Houston Area Clinical Trial Consultants, LLC

Houston, Texas, United States

Synergy Group Medical, LLC

Missouri City, Texas, United States

Permian Research Foundation

Odessa, Texas, United States

Carient Heart & Vascular

Manassas, Virginia, United States

Conquest Research

Vienna, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07626411


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