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Taking peoplePhase 3

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
Bielsko- Biała, Bydgoszcz, Cracow, Czeladz, Debica, Grodzisk Mazowiecki, Katowice, Krakow, Lodz, Lublin, Olsztyn, Oswiecim, Piaseczno, Poznan, Przemyśl, Pulawy, Ruda Śląska, Rzeszow, Rzeszów, Skierniewice, Sopot, Szczecin, Torun, Tychy, Warsaw, Warszawa, Wroclaw, Zamość, and Żarów, PolandSee the 43 sites
Phase
Phase 3

Where in Poland

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  • Futuremeds Sp. z o.o.Cracow, PolandNot yet recruiting
  • Unicardia Specjalistyczne Centrum Leczenia Chorob Serca I Naczyn & Unimedica Specjalistyczne Centrum Medyczne & Uniestetica Centrum Chirurgii Plastycznej Rekonstrukcyjnej I Medycyny Estetycznej Malopolskie Kliniki Specjalistyczne Sp. z o.o.Cracow, PolandNot yet recruiting
  • Centrum-Med Anna Drzewiecka Elzbieta Drzewiecka Sp. j.Czeladz, PolandNot yet recruiting
  • ETG Lublin Sp. z o.o.Debica, PolandNot yet recruiting
  • Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla IIGrodzisk Mazowiecki, PolandNot yet recruiting
  • Clinical Medical Research Sp. z o.o.Katowice, PolandNot yet recruiting
  • Kardio Brynów Sp. z o.o.Katowice, PolandNot yet recruiting
  • Vita Longa Sp. Z o.o.Katowice, PolandNot yet recruiting
  • Ewa Mirek-Bryniarska Specjalistyczna Praktyka LekarskaKrakow, PolandNot yet recruiting
  • Centrum Medyczne Med-Gastr Sp. z o.o.Lodz, PolandNot yet recruiting
  • Instytut Centrum Zdrowia Matki PolkiLodz, PolandNot yet recruiting
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W LodziLodz, PolandNot yet recruiting
  • Santa SP. z o.oLodz, PolandNot yet recruiting
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w LodziLodz, PolandNot yet recruiting
  • ETG Lublin Sp. z o.o.Lublin, PolandNot yet recruiting
  • Uniwersytecki Szpital Kliniczny nr 4 w LublinieLublin, PolandNot yet recruiting
  • FutureMeds Sp. z o.o.Olsztyn, PolandNot yet recruiting
  • Medicome Sp. z o.o.Oswiecim, PolandNot yet recruiting
  • Niepubliczny Zakład Opieki Zdrowotnej HeurekaPiaseczno, PolandNot yet recruiting
  • Uniwersytecki Szpital Kliniczny w PoznaniuPoznan, PolandNot yet recruiting
  • Wojewodzki Szpital im Sw Ojca Pio w PrzemysluPrzemyśl, PolandNot yet recruiting
  • Ko-Med Centra Kliniczne Sp. z o.o.Pulawy, PolandNot yet recruiting
  • Poradnia AKA-MED Centrum Sp. z o.o.Ruda Śląska, PolandNot yet recruiting
  • Ministerstwa Spraw Wewnetrznych I Administracji W Rzeszowie SPZOZRzeszow, PolandNot yet recruiting
  • EMED Centrum Usług Medycznych Ewa ŚmiałekRzeszów, PolandNot yet recruiting
  • Velocity Nova Sp. z o.o.Skierniewice, PolandNot yet recruiting
  • NZOZ "Pro Cordis" Sopockie Centrum Badań Kardiologicznych Paweł MiękusSopot, PolandNot yet recruiting
  • Indyw. Specj. Prakt. Lek. – Dr n. med. Robert Kaliszczak, kardiologia, chor. wewnSzczecin, PolandNot yet recruiting
  • Osrodek Badan Klinicznych LabMed Sp. z o.o.Szczecin, PolandNot yet recruiting
  • Wojewodzki Szpital Zespolony im. L. Rydygiera w ToruniuTorun, PolandNot yet recruiting
  • American Heart of Poland S.A.Tychy, PolandNot yet recruiting
  • Balsammedica Sp. z o. o.Warsaw, PolandNot yet recruiting
  • Clinical Best Solutions Sp. Z O.O. Sp.K.Warsaw, PolandNot yet recruiting
  • Etg Warszawa Sp. z o.o.Warsaw, PolandNot yet recruiting
  • Mcm Polimedica 2 Sp. z o.o.Warsaw, PolandNot yet recruiting
  • Centrum Medyczne Justmed Sp. z o.o.Warszawa, PolandNot yet recruiting
  • NBR Polska Tomasz KłodawskiWarszawa, PolandNot yet recruiting
  • Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.Wroclaw, PolandNot yet recruiting
  • Dolnośląski Szpital Specjalistyczny im. T. Marciniaka - Centrum Medycyny RatunkowejWroclaw, PolandNot yet recruiting
  • Etg Zamosc Sp. z o.o.Zamość, PolandNot yet recruiting
  • NZOZ Centrum Medyczne SERAFIN-MED Halina SerafinŻarów, PolandNot yet recruiting

Questions to ask the study team

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  2. Are travel costs paid?
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  4. What happens if I want to stop?
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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.

ClinicalTrials.gov NCT07626411 · EU CTIS 2025-521617-97-00