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
- Ancona, Arezzo, Bergamo, Brescia, Caserta, Catania, Cortona, Ferrara, Grosseto, Lecco, Messina, Padova, Pavia, Perugia, Pozzilli, Rome, Rozzano, Saronno, Sassari, Siracusa, and Turin, ItalySee the 25 sites
- Phase
- Phase 3
Where in Italy
- Azienda Ospedaliero-Universitaria delle MarcheAncona, ItalyNot yet recruiting
- Azienda Unita' Sanitaria Locale Toscana Sud EstArezzo, ItalyNot yet recruiting
- Cliniche Gavazzeni S.p.A.Bergamo, ItalyNot yet recruiting
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyNot yet recruiting
- Azienda Ospedaliera Sant'Anna E San Sebastiano Di CasertaCaserta, ItalyNot yet recruiting
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, ItalyNot yet recruiting
- Azienda Unita' Sanitaria Locale Toscana Sud EstCortona, ItalyNot yet recruiting
- University Hospital Of FerraraFerrara, ItalyNot yet recruiting
- Azienda Unita' Sanitaria Locale Toscana Sud EstGrosseto, ItalyNot yet recruiting
- Alessandro Manzoni HospitalLecco, ItalyNot yet recruiting
- Azienda Ospedaliera PapardoMessina, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria Gaetano Martino MessinaMessina, ItalyNot yet recruiting
- Azienda Ospedaliera di PadovaPadova, ItalyNot yet recruiting
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyNot yet recruiting
- Fondazione Istituto Neurologico Nazionale Casimiro MondinoPavia, ItalyNot yet recruiting
- Hospital Santa Maria Della MisericordiaPerugia, ItalyNot yet recruiting
- Istituto Neurologico Mediterraneo Neuromed S.p.A.Pozzilli, ItalyNot yet recruiting
- Azienda Sanitaria Locale Roma 2Rome, ItalyNot yet recruiting
- San Camillo Forlanini HospitalRome, ItalyNot yet recruiting
- Humanitas Mirasole S.p.A.Rozzano, ItalyNot yet recruiting
- Azienda Socio Sanitaria Territoriale Della Valle OlonaSaronno, ItalyNot yet recruiting
- Azienda Ospedaliero-Universitaria di SassariSassari, ItalyNot yet recruiting
- Azienda Sanitaria Provinciale di SiracusaSiracusa, ItalyNot yet recruiting
- Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyNot yet recruiting
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.