Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation

NCT07175428
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Recruiting
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Participants
1,200
clinicaltrials.gov
Lead sponsor
Regeneron Pharmaceuticals
clinicaltrials.gov
Start date
2025-10-20
clinicaltrials.gov
Number of sites
77
clinicaltrials.gov

Summary
This study is researching experimental drugs called REGN7508 and REGN9933. The study is focused on participants who have atrial fibrillation, which means that the heart beats too fast and unevenly. REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation. The aim of the study is to see how well REGN7508 and REGN9933 work in patients that get medicine for their atrial fibrillation. The bleeding effects of REGN7508 and REGN9933 will be compared to another medicine (apixaban), which is available on the market to treat and prevent formation of blood clots. The study is looking at several other research questions, including: * What side effects may happen from taking REGN7508 or REGN9933 * How well do the study drugs reduce the risk of having a stroke * How much of REGN7508 or REGN9933 is in the blood at different times * Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the drugs less effective or could lead to side effects)
clinicaltrials.gov
Acronym
ROXI-ATLAS
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Short title
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
clinicaltrials.gov
Official title
A Phase 2, Randomized, Multicenter, Open-label, Blinded-endpoint Study to Evaluate the Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against FXI, Versus Apixaban in Participants With Atrial Fibrillation (ROXI-ATLAS)
clinicaltrials.gov

Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 2
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Study type
Interventional
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Completion date
2027-04-21
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First posted
2025-09-16
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Registry last updated
2026-08-20
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Primary completion date
2027-02-09
clinicaltrials.gov
Start date
2025-10-20
clinicaltrials.gov

Participants
1,200
clinicaltrials.gov
Participant count basis
Estimated
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Planned participants
1,200
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Protocol amendments
2
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Number of sites
77
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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
clinicaltrials.gov

Registry ID
NCT07175428
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07175428
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Single masking
Masked roles
Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Incidence of any bleeding

    Timeframe: 12 weeks

    Defined as the composite of International Society on Thrombosis and Haemostasis (ISTH) major bleeding, ISTH Clinically Relevant Non-Major (CRNM) bleeding, or minor bleeding

  1. Incidence of the composite of ISTH major bleeding or ISTH CRNM bleeding

    Timeframe: 12 weeks

  2. Incidence of ISTH major bleeding

    Timeframe: 12 weeks

  3. Incidence of ISTH CRNM bleeding

    Timeframe: 12 weeks

  4. Incidence of minor bleeding

    Timeframe: 12 weeks

  5. Number of ISTH major bleeding events

    Timeframe: 12 weeks

  6. Number of ISTH CRNM bleeding events

    Timeframe: 12 weeks

  7. Number of minor bleeding events

    Timeframe: 12 weeks

  8. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Timeframe: Approximately 25 weeks

  9. Severity of TEAEs

    Timeframe: Approximately 25 weeks

  10. Incidence of the composite of stroke or systemic embolism

    Timeframe: Approximately 12 weeks

  11. Incidence of Antidrug Antibodies (ADA) to REGN7508

    Timeframe: 12 weeks

  12. Magnitude of ADA to REGN7508

    Timeframe: 12 weeks

  13. Incidence of ADA to REGN9933

    Timeframe: 12 weeks

  14. Magnitude of ADA to REGN9933

    Timeframe: 12 weeks

  15. Concentrations of REGN7508

    Timeframe: Approximately 25 weeks

  16. Concentrations of REGN9933

    Timeframe: Approximately 25 weeks

  17. Change from baseline in activated Partial Thromboplastin Time (aPTT)

    Timeframe: Approximately 25 weeks

  18. Change from baseline in Prothrombin Time (PT)

    Timeframe: Approximately 25 weeks

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 felt 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 Thromboembolism (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 Normalization 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 successful ablation therapy or Left Atrial Appendage (LAA) occlusion/exclusion, or planned ablation or LAA occlusion/exclusion as described in the protocol
  4. Had an ischemic stroke within 2 days prior to randomization
  5. Has estimated Glomerular Filtration Rate (eGFR) <15 mL/min/1.73m^2 within 30 days prior to randomization or on dialysis or expected to be started as described in the protocol
  6. Has a history of central nervous system bleeding within 30 days prior to randomization

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Sources for eligibility
clinicaltrials.gov

  • SEC Clinical ResearchDothan, United StatesRecruiting
  • Eastern Shore Research InstituteFairhope, United StatesRecruiting
  • Valley Clinical Trials, IncCovina, United StatesRecruiting
  • North Coast CardiologyEncinitas, United StatesRecruiting
  • Mission Cardiovascular Research InstituteFremont, United StatesRecruiting
  • National Institute of California Heart and Vein SpecialistsHuntington Beach, United StatesRecruiting
  • Profound Research LLC at Southern California Heart SpecialistsPasadena, United StatesRecruiting
  • Empire Clinical ResearchPomona, United StatesRecruiting
  • The Cardiovascular CenterRedding, United StatesRecruiting
  • Northbay Clinical Research CenterSanta Rosa, United StatesRecruiting
  • Cardiology Associates Medical GroupVentura, United StatesRecruiting
  • Interventional Cardiology Medical GroupWest Hills, United StatesRecruiting
  • Nouvelle Clinical Research LLCCutler Bay, United StatesRecruiting
  • South Florida Research Organization LLCMedley, United StatesRecruiting
  • Inpatient Research Clinic LLCMiami Lakes, United StatesRecruiting
  • Cardiovascular Center of Sarasota Foundation for Research and EducationSarasota, United StatesRecruiting
  • Clinical Site Partners, LLC DBA Flourish ResearchWinter Park, United StatesRecruiting
  • Grady Health SystemAtlanta, United StatesRecruiting
  • Health Sciences Research Building IIAtlanta, United StatesWithdrawn
  • NSC Research, IncJohns Creek, United StatesRecruiting
  • Indiana UniversityIndianapolis, United StatesRecruiting
  • Blue Coast Research Center, LLCIndianapolis, United StatesRecruiting
  • Franciscan Physician Network, Indiana Heart PhysiciansIndianapolis, United StatesRecruiting
  • Indiana Medical ResearchMerrillville, United StatesRecruiting
  • Reid Physician AssociatesRichmond, United StatesRecruiting

And 52 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (4)

Targets (3)