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Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation

RecruitingPhase 3

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)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Key Inclusion Criteria:

1. Has AF or flutter (paroxysmal or persistent), not considered 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 \[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Systemic embolism (double points); V: Vascular disease; A: Age 65-74 years\] 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 Normalized 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 a successful ablation therapy without documented recurrent AF or a participant after Left Atrial Appendage (LAA) occlusion/exclusion or plan for ablation or LAA occlusion/exclusion within the next 6 months starting from randomization
4. Had an ischemic stroke within 2 days prior to randomization
5. Has persistent, uncontrolled hypertension (per investigator's discretion)
6. Has estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73m2 within 30 days prior to randomization or is on dialysis or expected to be started on dialysis within the next 6 months starting from randomization

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

About the study

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)

What is being tested

Sponsor: Regeneron Pharmaceuticals · Participants: 15,364 · Started: Aug 10, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07626411

Locations in the U.S.

AlabamaAdvanced Cardiovascular, Alexander City
SEC Clinical Research, Dothan
Eastern Shore Research Institute, Fairhope
ArizonaWest Valley Clinical Trials, Glendale
Scottsdale Clinical Trials, Scottsdale
ArkansasArkansas Cardiology P.A., Little Rock
CaliforniaValley Clinical Trials, Inc, Covina
Mission Cardiovascular Research Institute, Fremont
National Institute of California Heart and Vein Specialists, Huntington Beach
Alliance Clinical Los Angeles, Inglewood
Profound Research LLC at San Diego Cardiovascular Associates, La Jolla
Radin Cardiovascular Medical Group, Newport Beach
Valley Clinical Trials, LLC dba Flourish Research, Northridge
Southern California Heart Specialists, Pasadena
FOMAT - Comprehensive Cardiovascular Care, Santa Maria
Cardiology Associates Medical Group, Ventura
Interventional Cardiology Medical Group, West Hills
FloridaExcel Medical Clinical Trials, dba Flourish Research, Boca Raton
Nouvelle Clinical Research LLC, Cutler Bay
Nature Coast Clinical Research - Inverness, Inverness
South Florida Research Organization LLC, Medley
Healix Clinical Research, New Smyrna Beach
Sec Clinical Research, Pensacola
Flourish Research, St. Johns Center for Clinical Research, Saint Augustine
Cardiovascular Center of Sarasota Foundation for Research and Education, Sarasota
Clinical Site Partners, LLC DBA Flourish Research, Winter Park
GeorgiaAtlanta Clinical Research Centers, Atlanta
Morehouse School Of Medicine, Atlanta
NSC Research, Inc, Johns Creek
IndianaProfound Research, Advanced Cardiovascular Care + Electrophysiology Clinic, Hobart
Cardiovascular Research of Northwest Indiana, LLC, Munster
Profound Research, Powers Health Medical Group - Electrophysiology, Munster
LouisianaMonroe Research, LLC, West Monroe
MarylandAnderson Medical Research, Ft. Washington
MassachusettsK2 Medical Research, Foxboro, Foxborough
MichiganProfound Research, Cardiology and Vascular Associates (CAVA) - Bloomfield Hills, Bloomfield Hills
Profound Research, Millennium Cardiology, Farmington Hills
Flint Clinical Research, Flint
New YorkSuper Health Pharmacy, Staten Island
North CarolinaHawthorne Health, Moose Pharmacy of Concord, Concord
Peters Medical Research, High Point
North DakotaLillestol Research LLC, Fargo
OhioK&R Research LLC, Marion
Advanced Medical Research, Maumee
South DakotaMonument Health Clinical Research, Rapid City
TennesseeTennessee Center for Clinical Trials, Tullahoma
TexasPharmaTex Research, Amarillo
PanAmerican Clinical Research, Brownsville
Synergy Groups Medical, Houston
West Houston Area Clinical Trial Consultants, LLC, Houston
Synergy Group Medical, LLC, Missouri City
Permian Research Foundation, Odessa
Tyler Cardiovascular Consultants, Tyler
UtahAlpine Research TC, Clinton
VirginiaCarient Heart & Vascular, Manassas
Conquest Research, Vienna

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.