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Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Sponsor: Regeneron Pharmaceuticals
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)
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15364
Start Date
2026-08-10
Completion Date
2029-12-10
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
REGN7508
Administered per the protocol
Apixaban
Administered per the protocol
Placebo
Administered per the protocol
Locations (45)
Advanced Cardiovascular
Alexander City, Alabama, United States
SEC Clinical Research
Dothan, Alabama, United States
Eastern Shore Research Institute
Fairhope, Alabama, United States
Sun City Clinical Research
Glendale, Arizona, United States
Arkansas Cardiology P.A.
Little Rock, Arkansas, 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 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
FOMAT - Comprehensive Cardiovascular Care
Santa Maria, 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
Healix Clinical Research
New Smyrna Beach, Florida, United States
Sec Clinical Research
Pensacola, Florida, United States
Flourish Research, St. Johns Center for Clinical Research
Saint Augustine, 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
Atlanta Clinical Research Centers
Atlanta, Georgia, United States
NSC Research, Inc
Johns Creek, Georgia, United States
Cardiovascular Research of Northwest Indiana, LLC
Munster, Indiana, 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
Peters Medical Research
High Point, 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
Tyler Cardiovascular Consultants
Tyler, Texas, United States
Alpine Research TC
Clinton, Utah, United States
Carient Heart & Vascular
Manassas, Virginia, United States
Conquest Research
Vienna, Virginia, United States
Rakuwakai Otowa Hospital
Kyoto, Kyoto, Japan