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Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation (ROXI-EVEREST)

15. september 2026 oppdatert av: Regeneron Pharmaceuticals

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)

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

15364

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Alabama
      • Alexander City, Alabama, Forente stater, 35010
        • Rekruttering
        • Advanced Cardiovascular
      • Dothan, Alabama, Forente stater, 36305
        • Rekruttering
        • Sec Clinical Research
    • Arizona
      • Glendale, Arizona, Forente stater, 85351
        • Rekruttering
        • Sun City Clinical Research
    • California
      • Fremont, California, Forente stater, 94538
        • Rekruttering
        • Mission Cardiovascular Research Institute
      • La Jolla, California, Forente stater, 92037
        • Rekruttering
        • Profound Research LLC at San Diego Cardiovascular Associates
      • Newport Beach, California, Forente stater, 92663
        • Rekruttering
        • Radin Cardiovascular Medical Group
      • Northridge, California, Forente stater, 91325
        • Rekruttering
        • Valley Clinical Trials, LLC dba Flourish Research
      • Pasadena, California, Forente stater, 91105
        • Rekruttering
        • Southern California Heart Specialists
      • Ventura, California, Forente stater, 93003
        • Rekruttering
        • Cardiology Associates Medical Group
      • West Hills, California, Forente stater, 91307
        • Rekruttering
        • Interventional Cardiology Medical Group
    • Florida
      • Cutler Bay, Florida, Forente stater, 33189
        • Rekruttering
        • Nouvelle Clinical Research LLC
      • Pensacola, Florida, Forente stater, 32503
        • Rekruttering
        • Sec Clinical Research
      • Sarasota, Florida, Forente stater, 34239
        • Rekruttering
        • Cardiovascular Center of Sarasota Foundation for Research and Education
    • Georgia
      • Atlanta, Georgia, Forente stater, 30342
        • Rekruttering
        • Atlanta Clinical Research Centers
      • Johns Creek, Georgia, Forente stater, 30024
        • Rekruttering
        • NSC Research, Inc
    • Indiana
      • Munster, Indiana, Forente stater, 46321
        • Rekruttering
        • Profound Research, Powers Health Medical Group - Electrophysiology
    • Louisiana
      • West Monroe, Louisiana, Forente stater, 71291
        • Rekruttering
        • Monroe Research, LLC
    • Maryland
      • Ft. Washington, Maryland, Forente stater, 20744
        • Rekruttering
        • Anderson Medical Research
    • Michigan
      • Bloomfield Hills, Michigan, Forente stater, 48304
        • Rekruttering
        • Profound Research, Cardiology and Vascular Associates (CAVA) - Bloomfield Hills
      • Farmington Hills, Michigan, Forente stater, 48334
        • Rekruttering
        • Profound Research, Millennium Cardiology
    • New York
      • Staten Island, New York, Forente stater, 10309
        • Rekruttering
        • Super Health Pharmacy
    • North Carolina
      • Concord, North Carolina, Forente stater, 28025
        • Rekruttering
        • Hawthorne Health, Moose Pharmacy of Concord
    • Ohio
      • Marion, Ohio, Forente stater, 43302
        • Rekruttering
        • K&R Research LLC
    • Tennessee
      • Tullahoma, Tennessee, Forente stater, 37388
        • Rekruttering
        • Tennessee Center for Clinical Trials
    • Texas
      • Amarillo, Texas, Forente stater, 79106
        • Rekruttering
        • PharmaTex Research
      • Brownsville, Texas, Forente stater, 78520
        • Rekruttering
        • PanAmerican Clinical Research
      • Houston, Texas, Forente stater, 77061
        • Rekruttering
        • Synergy Groups Medical
      • Houston, Texas, Forente stater, 77094
        • Rekruttering
        • West Houston Area Clinical Trial Consultants, LLC
      • Missouri City, Texas, Forente stater, 77459
        • Rekruttering
        • Synergy Group Medical, LLC
      • Odessa, Texas, Forente stater, 79761
        • Rekruttering
        • Permian Research Foundation
    • Virginia
      • Manassas, Virginia, Forente stater, 20109
        • Rekruttering
        • Carient Heart & Vascular
      • Vienna, Virginia, Forente stater, 22182
        • Rekruttering
        • Conquest Research

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: REGN7508 + Placebo
Legemiddel: Placebo
Administrert i henhold til protokollen
Legemiddel: Regn7508
Administrert i henhold til protokollen
Andre navn:
  • cenvacibart
Aktiv komparator: Apixaban + Placebo
Legemiddel: Placebo
Administrert i henhold til protokollen
Legemiddel: Apixaban
Administrert i henhold til protokollen

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type) or systemic embolism
Tidsramme: Approximately 36 months
Approximately 36 months
Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding or ISTH Clinically Relevant Non-Major (CRNM) bleeding
Tidsramme: Approximately 36 months
Approximately 36 months

Sekundære resultatmål

Resultatmål
Tidsramme
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or ISTH CRNM bleeding
Tidsramme: Approximately 36 months
Approximately 36 months
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, or ISTH major bleeding
Tidsramme: Approximately 36 months
Approximately 36 months
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or all-cause death
Tidsramme: Approximately 36 months
Approximately 36 months
Time to first occurrence of ISTH major bleeding
Tidsramme: Approximately 36 months
Approximately 36 months
Time to first occurrence of hemorrhagic stroke, intracerebral hemorrhage, or hemorrhagic transformation of an ischemic stroke
Tidsramme: Approximately 36 months
Approximately 36 months
Time to occurrence of fatal bleeding
Tidsramme: Approximately 36 months
Approximately 36 months
Number of ISTH major bleeding events
Tidsramme: Approximately 36 months
Approximately 36 months
Number of ISTH CRNM bleeding events
Tidsramme: Approximately 36 months
Approximately 36 months
Number of minor bleeding events
Tidsramme: Approximately 36 months
Approximately 36 months
Time to all-cause death
Tidsramme: Approximately 36 months
Approximately 36 months
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: Approximately 39 months
Approximately 39 months
Severity of TEAEs
Tidsramme: Approximately 39 months
Approximately 39 months
Occurrence of Anti-Drug Antibodies (ADA) to REGN7508
Tidsramme: Approximately 36 months
Approximately 36 months
Magnitude of ADA to REGN7508
Tidsramme: Approximately 36 months
Approximately 36 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Regeneron Pharmaceuticals

Etterforskere

  • Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. august 2026

Primær fullføring (Antatt)

11. september 2029

Studiet fullført (Antatt)

10. desember 2029

Datoer for studieregistrering

Først innsendt

29. mai 2026

Først innsendt som oppfylte QC-kriteriene

29. mai 2026

Først lagt ut (Faktiske)

4. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R7508-CVA-24114
  • 2025 (U.S. NIH-stipend/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-521617-97-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD-delingstidsramme

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

Tilgangskriterier for IPD-deling

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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