Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation

NCT07626411
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
15,364
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Lead sponsor
Regeneron Pharmaceuticals
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Start date
2026-08-10
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Number of sites
8
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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. 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)
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Acronym
ROXI-EVEREST
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Short title
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
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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)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-12-10
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First posted
2026-06-04
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Registry last updated
2026-08-25
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Primary completion date
2029-09-11
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Start date
2026-08-10
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Participants
15,364
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Participant count basis
Estimated
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Planned participants
15,364
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Protocol amendments
0
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Number of sites
8
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Regeneron Pharmaceuticals
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07626411
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ClinicalTrials.gov ID
NCT07626411
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: 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

    Timeframe: Approximately 36 months

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

    Timeframe: Approximately 36 months

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

    Timeframe: 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

    Timeframe: Approximately 36 months

  4. Time to first occurrence of ISTH major bleeding

    Timeframe: Approximately 36 months

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

    Timeframe: Approximately 36 months

  6. Time to occurrence of fatal bleeding

    Timeframe: Approximately 36 months

  7. Number of ISTH major bleeding events

    Timeframe: Approximately 36 months

  8. Number of ISTH CRNM bleeding events

    Timeframe: Approximately 36 months

  9. Number of minor bleeding events

    Timeframe: Approximately 36 months

  10. Time to all-cause death

    Timeframe: Approximately 36 months

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

    Timeframe: Approximately 39 months

  12. Severity of TEAEs

    Timeframe: Approximately 39 months

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

    Timeframe: Approximately 36 months

  14. Magnitude of ADA to REGN7508

    Timeframe: Approximately 36 months

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

Sources for eligibility
clinicaltrials.gov

  • SEC Clinical ResearchDothan, United StatesRecruiting
  • Radin Cardiovascular Medical GroupNewport Beach, United StatesRecruiting
  • Southern California Heart SpecialistsPasadena, United StatesRecruiting
  • Sec Clinical ResearchPensacola, United StatesRecruiting
  • Monroe Research, LLCWest Monroe, United StatesRecruiting
  • PharmaTex ResearchAmarillo, United StatesRecruiting
  • West Houston Area Clinical Trial Consultants, LLCHouston, United StatesRecruiting
  • Permian Research FoundationOdessa, United StatesRecruiting
Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-521617-97-00
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (4)

Targets (3)