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Atrial Fibrillation (AF)Phase 3ROXI-EVERESTNCT07626411

Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation

A Phase 3 study testing REGN7508 and Apixaban in people with Atrial Fibrillation (AF), run by Regeneron Pharmaceuticals at 45 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation (AF)
What is being tested?
REGN7508 and Apixaban
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15,364 participants
Where
45 sitesin 2 countries
Study dates
10 Aug 2026to 10 Dec 2029
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)
  • Has known moderate-to-severe mitral stenosis
  • 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 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

Trial locations and contacts

45 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

45 sites in 2 countries

United States44 sites, 44 recruiting

  • Advanced Cardiovascular

    Alexander City, Alabama, 35010

    Recruiting

  • PharmaTex Research

    Amarillo, Texas, 79106

    Recruiting

  • Atlanta Clinical Research Centers

    Atlanta, Georgia, 30342

    Recruiting

  • Profound Research, Cardiology and Vascular Associates (CAVA) - Bloomfield Hills

    Bloomfield Hills, Michigan, 48304

    Recruiting

  • PanAmerican Clinical Research

    Brownsville, Texas, 78520

    Recruiting

  • Alpine Research TC

    Clinton, Utah, 84015

    Recruiting

  • Hawthorne Health, Moose Pharmacy of Concord

    Concord, North Carolina, 28025

    Recruiting

  • Nouvelle Clinical Research LLC

    Cutler Bay, Florida, 33189

    Recruiting

  • SEC Clinical Research

    Dothan, Alabama, 36305

    Recruiting

  • Eastern Shore Research Institute

    Fairhope, Alabama, 36532

    Recruiting

  • Profound Research, Millennium Cardiology

    Farmington Hills, Michigan, 48334

    Recruiting

  • Mission Cardiovascular Research Institute

    Fremont, California, 94538

    Recruiting

  • Anderson Medical Research

    Ft. Washington, Maryland, 20744

    Recruiting

  • Sun City Clinical Research

    Glendale, Arizona, 85351

    Recruiting

  • Peters Medical Research

    High Point, North Carolina, 27260

    Recruiting

  • Synergy Groups Medical

    Houston, Texas, 77061

    Recruiting

  • West Houston Area Clinical Trial Consultants, LLC

    Houston, Texas, 77094

    Recruiting

  • National Institute of California Heart and Vein Specialists

    Huntington Beach, California, 92648

    Recruiting

  • NSC Research, Inc

    Johns Creek, Georgia, 30024

    Recruiting

  • Profound Research LLC at San Diego Cardiovascular Associates

    La Jolla, California, 92037

    Recruiting

  • Arkansas Cardiology P.A.

    Little Rock, Arkansas, 72205

    Recruiting

  • Carient Heart & Vascular

    Manassas, Virginia, 20109

    Recruiting

  • K&R Research LLC

    Marion, Ohio, 43302

    Recruiting

  • South Florida Research Organization LLC

    Medley, Florida, 33166

    Recruiting

  • Synergy Group Medical, LLC

    Missouri City, Texas, 77459

    Recruiting

  • Cardiovascular Research of Northwest Indiana, LLC

    Munster, Indiana, 46321-4054

    Recruiting

  • Profound Research, Powers Health Medical Group - Electrophysiology

    Munster, Indiana, 46321

    Recruiting

  • Healix Clinical Research

    New Smyrna Beach, Florida, 32168

    Recruiting

  • Radin Cardiovascular Medical Group

    Newport Beach, California, 92663

    Recruiting

  • Valley Clinical Trials, LLC dba Flourish Research

    Northridge, California, 91325

    Recruiting

  • Permian Research Foundation

    Odessa, Texas, 79761

    Recruiting

  • Southern California Heart Specialists

    Pasadena, California, 91105

    Recruiting

  • Sec Clinical Research

    Pensacola, Florida, 32503

    Recruiting

  • Flourish Research, St. Johns Center for Clinical Research

    Saint Augustine, Florida, 32086

    Recruiting

  • FOMAT - Comprehensive Cardiovascular Care

    Santa Maria, California, 93454

    Recruiting

  • Cardiovascular Center of Sarasota Foundation for Research and Education

    Sarasota, Florida, 34239

    Recruiting

  • Super Health Pharmacy

    Staten Island, New York, 10309

    Recruiting

  • Tennessee Center for Clinical Trials

    Tullahoma, Tennessee, 37388

    Recruiting

  • Tyler Cardiovascular Consultants

    Tyler, Texas, 75701

    Recruiting

  • Cardiology Associates Medical Group

    Ventura, California, 93003

    Recruiting

  • Conquest Research

    Vienna, Virginia, 22182

    Recruiting

  • Interventional Cardiology Medical Group

    West Hills, California, 91307

    Recruiting

  • Monroe Research, LLC

    West Monroe, Louisiana, 71291

    Recruiting

  • Clinical Site Partners, LLC DBA Flourish Research

    Winter Park, Florida, 32789

    Recruiting

Other trials in United States

Japan1 site, 1 recruiting

  • Rakuwakai Otowa Hospital

    Kyoto, Kyoto, 607-8062

    Recruiting

Other trials in Japan

About this study

Official title: 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.

Read more

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)
Being tested
REGN7508, Apixaban, Placebo
Keywords
Bleeding, Stroke, Systemic embolism, Blood clots
Medical subject headings
Atrial Fibrillation, Hemorrhage, Stroke, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REGN7508Drug

    Also called cenvacibart

    Administered per the protocol

  • ApixabanDrug

    Administered per the protocol

  • PlaceboDrug

    Administered per the protocol

Study groups in NCT07626411
Study groupRoleWhat they receive
REGN7508 + PlaceboExperimentalNot described
Receives: Drug: REGN7508; Drug: Placebo
Apixaban + PlaceboActive comparatorNot described
Receives: Drug: Apixaban; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type) or systemic embolism

    Measured: Approximately 36 months

  2. Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding or ISTH Clinically Relevant Non-Major (CRNM) bleeding

    Measured: Approximately 36 months

Secondary outcomes (14)

  1. Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or ISTH CRNM bleeding

    Measured: Approximately 36 months

  2. Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, or ISTH major bleeding

    Measured: Approximately 36 months

  3. Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or all-cause death

    Measured: Approximately 36 months

  4. Time to first occurrence of ISTH major bleeding

    Measured: Approximately 36 months

  5. Time to first occurrence of hemorrhagic stroke, intracerebral hemorrhage, or hemorrhagic transformation of an ischemic stroke

    Measured: Approximately 36 months

  6. Time to occurrence of fatal bleeding

    Measured: Approximately 36 months

  7. Number of ISTH major bleeding events

    Measured: Approximately 36 months

  8. Number of ISTH CRNM bleeding events

    Measured: Approximately 36 months

  9. Number of minor bleeding events

    Measured: Approximately 36 months

  10. Time to all-cause death

    Measured: Approximately 36 months

  11. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Measured: Approximately 39 months

  12. Severity of TEAEs

    Measured: Approximately 39 months

  13. Occurrence of Anti-Drug Antibodies (ADA) to REGN7508

    Measured: Approximately 36 months

  14. Magnitude of ADA to REGN7508

    Measured: Approximately 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2026
  2. Study start10 Aug 2026
  3. Primary completion11 Sep 2029 (estimated)
  4. Study completion10 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
15,364 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07626411
Sponsor's protocol ID
R7508-CVA-24114
Other IDs
2025-521617-97-00, 2025
Acronym
ROXI-EVEREST
Status last verified
Oct 2026
First submitted
29 May 2026
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

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