REGN7508 compared with apixaban to prevent stroke in atrial fibrillation
Compares REGN7508 with apixaban for preventing stroke in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Key facts
- Where
- Alexander City, Amarillo, Atlanta, Bloomfield Hills, Boca Raton, Brownsville, Clinton, Concord, Covina, Cutler Bay, Dothan, Fairhope, Fargo, Farmington Hills, Flint, Foxborough, Fremont, Ft. Washington, Glendale, High Point, Hobart, Houston, Huntington Beach, Inglewood, Inverness, Johns Creek, La Jolla, Little Rock, Manassas, Marion, Maumee, Medley, Missouri City, Munster, New Smyrna Beach, Newport Beach, Northridge, Odessa, Pasadena, Pensacola, Rapid City, Saint Augustine, Santa Maria, Sarasota, Scottsdale, Staten Island, Tullahoma, Tyler, Ventura, Vienna, West Hills, West Monroe, and Winter Park, United StatesSee the 56 sites
- Phase
- Phase 3
Where in United States
- Advanced CardiovascularAlexander City, United StatesTaking people
- PharmaTex ResearchAmarillo, United StatesTaking people
- Atlanta Clinical Research CentersAtlanta, United StatesTaking people
- Morehouse School of MedicineAtlanta, United StatesTaking people
- Profound Research, Cardiology and Vascular Associates (CAVA) - Bloomfield HillsBloomfield Hills, United StatesTaking people
- Excel Medical Clinical Trials, dba Flourish ResearchBoca Raton, United StatesTaking people
- PanAmerican Clinical ResearchBrownsville, United StatesTaking people
- Alpine Research TCClinton, United StatesTaking people
- Hawthorne Health, Moose Pharmacy of ConcordConcord, United StatesTaking people
- Valley Clinical Trials, Inc.Covina, United StatesTaking people
- Nouvelle Clinical Research LLCCutler Bay, United StatesTaking people
- SEC Clinical ResearchDothan, United StatesTaking people
- Eastern Shore Research InstituteFairhope, United StatesTaking people
- Lillestol Research, LLCFargo, United StatesTaking people
- Profound Research, Millennium CardiologyFarmington Hills, United StatesTaking people
- Flint Clinical ResearchFlint, United StatesTaking people
- K2 Medical Research, FoxboroFoxborough, United StatesTaking people
- Mission Cardiovascular Research InstituteFremont, United StatesTaking people
- Anderson Medical ResearchFt. Washington, United StatesTaking people
- West Valley Clinical TrialsGlendale, United StatesTaking people
- Peters Medical ResearchHigh Point, United StatesTaking people
- Profound Research, Advanced Cardiovascular Care + Electrophysiology ClinicHobart, United StatesTaking people
- Synergy Groups MedicalHouston, United StatesTaking people
- West Houston Area Clinical Trial Consultants, LLCHouston, United StatesTaking people
- National Institute of California Heart and Vein SpecialistsHuntington Beach, United StatesTaking people
- Alliance Clinical Los AngelesInglewood, United StatesTaking people
- Nature Coast Clinical Research - InvernessInverness, United StatesTaking people
- NSC Research, IncJohns Creek, United StatesTaking people
- Profound Research LLC at San Diego Cardiovascular AssociatesLa Jolla, United StatesTaking people
- Arkansas Cardiology P.A.Little Rock, United StatesTaking people
- Carient Heart & VascularManassas, United StatesTaking people
- K&R Research LLCMarion, United StatesTaking people
- Advanced Medical ResearchMaumee, United StatesTaking people
- South Florida Research Organization LLCMedley, United StatesTaking people
- Synergy Group Medical, LLCMissouri City, United StatesTaking people
- Cardiovascular Research of Northwest Indiana, LLCMunster, United StatesTaking people
- Profound Research, Powers Health Medical Group - ElectrophysiologyMunster, United StatesTaking people
- Healix Clinical ResearchNew Smyrna Beach, United StatesTaking people
- Radin Cardiovascular Medical GroupNewport Beach, United StatesTaking people
- Valley Clinical Trials, LLC dba Flourish ResearchNorthridge, United StatesTaking people
- Permian Research FoundationOdessa, United StatesTaking people
- Southern California Heart SpecialistsPasadena, United StatesTaking people
- Sec Clinical ResearchPensacola, United StatesTaking people
- Monument Health Clinical ResearchRapid City, United StatesTaking people
- Flourish Research, St. Johns Center for Clinical ResearchSaint Augustine, United StatesTaking people
- FOMAT - Comprehensive Cardiovascular CareSanta Maria, United StatesTaking people
- Cardiovascular Center of Sarasota Foundation for Research and EducationSarasota, United StatesTaking people
- Scottsdale Clinical TrialsScottsdale, United StatesTaking people
- Super Health PharmacyStaten Island, United StatesTaking people
- Tennessee Center for Clinical TrialsTullahoma, United StatesTaking people
- Tyler Cardiovascular ConsultantsTyler, United StatesTaking people
- Cardiology Associates Medical GroupVentura, United StatesTaking people
- Conquest ResearchVienna, United StatesTaking people
- Interventional Cardiology Medical GroupWest Hills, United StatesTaking people
- Monroe Research, LLCWest Monroe, United StatesTaking people
- Clinical Site Partners, LLC dba Flourish ResearchWinter Park, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regeneron Pharmaceuticals
- Trial code
- NCT07626411EU 2025-521617-97-00
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
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)
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)
Inclusion: 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; 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 Systemic embolism (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 Normalized Ratio (INR) <2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA).
Exclusion: 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; Had an ischemic stroke within 2 days prior to randomization; Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion); Has persistent, uncontrolled hypertension (per investigator's discretion); 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; Has known moderate-to-severe mitral stenosis.