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

Last updated: May 8, 2026
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Stroke

Chest Pain

Cardiac Disease

Treatment

REGN7508

Apixaban

REGN9933

Clinical Study ID

NCT07175428
R7508-CVA-2393
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Has AF or flutter (paroxysmal or persistent), not felt to be secondary to areversible cause, and an indication for indefinite anticoagulation treatment asdescribed in the protocol

  2. Meets one of the following:

  3. 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 OralAnticoagulant (OAC) naïve or

  4. CHA2DS2-VA score ≥3 or

  5. CHA2DS2-VA score of 2 and at least 1 enrichment criteria as described in theprotocol

  6. Must have an International Normalization Ratio (INR) <2.5 at the time ofrandomization if taking warfarin or another Vitamin K Antagonist (VKA)

Exclusion

Key Exclusion Criteria:

  1. Has a mechanical heart valve prosthesis (Note: transcatheter aortic valvereplacement 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 inthe 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 daysprior to randomization or on dialysis or expected to be started as described in theprotocol

  6. Has a history of central nervous system bleeding within 30 days prior torandomization

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Study Design

Total Participants: 1200
Treatment Group(s): 3
Primary Treatment: REGN7508
Phase: 2
Study Start date:
October 20, 2025
Estimated Completion Date:
April 21, 2027

Connect with a study center

  • University of Alberta Hospital - Cardiology

    Edmonton, Alberta T6G 2G3
    Canada

    Active - Recruiting

  • GA Research Associates Ltd.

    Moncton, New Brunswick E1G-1A7
    Canada

    Active - Recruiting

  • Health sciences North - Cardiology

    Greater Sudbury, Ontario P3E 5J1
    Canada

    Active - Recruiting

  • Dr James Cha

    Oshawa, Ontario L1J 2K1
    Canada

    Active - Recruiting

  • Heart Health Institute Research Inc. - Cardiology

    Scarborough Village, Ontario M1B 4Z8
    Canada

    Active - Recruiting

  • Dr James Cha

    Oshawa 6094578, Ontario 6093943 L1J 2K1
    Canada

    Site Not Available

  • Heart Health Institute Research Inc. - Cardiology

    Scarborough Village 6141900, Ontario 6093943 M1B 4Z8
    Canada

    Site Not Available

  • Viacar Recherches Cliniques Inc. - Cardiologie

    Longueuil, Quebec J4H 4B9
    Canada

    Active - Recruiting

  • Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Cardiologie

    Sherbrooke, Quebec J1H 5N4
    Canada

    Active - Recruiting

  • Diex Recherche Inc.

    Sherbrooke, Quebec J1LOK3
    Canada

    Active - Recruiting

  • Diex Recherche Trois-rivieres

    Trois-Rivières, Quebec G9A 4P3
    Canada

    Active - Recruiting

  • CHU de Quebec-Universite Laval

    Québec, G1R 2J6
    Canada

    Active - Recruiting

  • SEC Clinical Research

    Dothan, Alabama 36305
    United States

    Active - Recruiting

  • Eastern Shore Research Institute

    Fairhope, Alabama 36532
    United States

    Active - Recruiting

  • SEC Clinical Research

    Dothan 4059102, Alabama 4829764 36305
    United States

    Site Not Available

  • SEC Clinical Research - Cardiology

    Dothan 4059102, Alabama 4829764 36305
    United States

    Active - Recruiting

  • Eastern Shore Research Institute

    Fairhope 4061234, Alabama 4829764 36532
    United States

    Site Not Available

  • Eastern Shore Research Institute, LLC

    Fairhope 4061234, Alabama 4829764 36532
    United States

    Active - Recruiting

  • Mission Cardiovascular Research Institute

    Fremont, California 94538
    United States

    Active - Recruiting

  • National Institute of California Heart and Vein Specialists

    Huntington Beach, California 92648
    United States

    Active - Recruiting

  • Profound Research LLC at Southern California Heart Specialists

    Pasadena, California 91105
    United States

    Active - Recruiting

  • Empire Clinical Research

    Pomona, California 91767
    United States

    Active - Recruiting

  • Northbay Clinical Research Center

    Santa Rosa, California 95405
    United States

    Active - Recruiting

  • Cardiology Associates Medical Group

    Ventura, California 93003
    United States

    Active - Recruiting

  • Interventional Cardiology Medical Group

    West Hills, California 91307
    United States

    Active - Recruiting

  • Mission Cardiovascular Research Institute

    Fremont 5350734, California 5332921 94538
    United States

    Site Not Available

  • National Institute of California Heart and Vein Specialists

    Huntington Beach 5358705, California 5332921 92648
    United States

    Site Not Available

  • National Institute of Clinical Research, Inc. / California Heart Specialists - Cardiology

    Huntington Beach 5358705, California 5332921 92648
    United States

    Active - Recruiting

  • Profound Research LLC at Southern California Heart Specialists

    Pasadena 5381396, California 5332921 91105
    United States

    Site Not Available

  • Empire Clinical Research

    Pomona 5384170, California 5332921 91767
    United States

    Site Not Available

  • Empire Clinical Research - Internal Medicine / Cardiology

    Pomona 5384170, California 5332921 91767
    United States

    Active - Recruiting

  • Cardiology Associates Medical Group

    Ventura 5405878, California 5332921 93003
    United States

    Site Not Available

  • Interventional Cardiology Medical Group

    West Hills 8030162, California 5332921 91307
    United States

    Site Not Available

  • Nouvelle Clinical Research LLC

    Cutler Bay, Florida 33189
    United States

    Active - Recruiting

  • Inpatient Research Clinic LLC

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Cardiovascular Center of Sarasota Foundation for Research and Education

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Clinical Site Partners, LLC DBA Flourish Research

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Nouvelle Clinical Research LLC

    Cutler Bay 6332309, Florida 4155751 33189
    United States

    Site Not Available

  • Nouvelle Clinical Research LLC - Cardiology

    Cutler Bay 6332309, Florida 4155751 33189
    United States

    Active - Recruiting

  • Inpatient Research Clinic LLC

    Miami Lakes 4164186, Florida 4155751 33014
    United States

    Site Not Available

  • Cardiovascular Center of Sarasota Foundation for Research and Education

    Sarasota 4172131, Florida 4155751 34239
    United States

    Site Not Available

  • Clinical Site Partners, LLC DBA Flourish Research

    Winter Park 4178560, Florida 4155751 32789
    United States

    Site Not Available

  • Health Sciences Research Building II

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • NSC Research, Inc

    Johns Creek, Georgia 30024
    United States

    Active - Recruiting

  • Health Sciences Research Building II

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • NSC Research, Inc

    Johns Creek 6331909, Georgia 4197000 30024
    United States

    Site Not Available

  • Blue Coast Research Center, LLC

    Indianapolis, Indiana 46237
    United States

    Active - Recruiting

  • Franciscan Physician Network, Indiana Heart Physicians

    Indianapolis, Indiana 46237
    United States

    Active - Recruiting

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Indiana Medical Research

    Merrillville, Indiana 46410
    United States

    Active - Recruiting

  • Reid Physician Associates

    Richmond, Indiana 47374
    United States

    Active - Recruiting

  • Blue Coast Research Center, LLC

    Indianapolis 4259418, Indiana 4921868 46237
    United States

    Active - Recruiting

  • Franciscan Physician Network, Indiana Heart Physicians

    Indianapolis 4259418, Indiana 4921868 46237
    United States

    Site Not Available

  • Reid Physician Associates

    Richmond 4263681, Indiana 4921868 47374
    United States

    Site Not Available

  • Monroe Research, LLC

    West Monroe, Louisiana 71291
    United States

    Active - Recruiting

  • Monroe Research, LLC

    West Monroe 4345850, Louisiana 4331987 71291
    United States

    Site Not Available

  • Monroe Research, LLC - Cardiology

    West Monroe 4345850, Louisiana 4331987 71291
    United States

    Active - Recruiting

  • Anderson Medical Research

    Ft. Washington, Maryland 20744
    United States

    Active - Recruiting

  • Anderson Medical Research

    Ft. Washington 4355355, Maryland 4361885 20744
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Beth Israel Lahey Health, Beth Israel Deaconess Medical Center (BIDMC)

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Profound Research LLC

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • AA Medical Research Center (MRC)

    Flint, Michigan 48504
    United States

    Active - Recruiting

  • Profound Research LLC

    Farmington Hills 4992523, Michigan 5001836 48334
    United States

    Site Not Available

  • Profound Research LLC at Pulse Cardiology

    Farmington Hills 4992523, Michigan 5001836 48334
    United States

    Active - Recruiting

  • AA Medical Research Center (MRC)

    Flint 4992982, Michigan 5001836 48504
    United States

    Site Not Available

  • Moses Cone Hospital Operating Corporation dba Cone Health, Lebauer-Brodie Center for Cardiovascular Research

    Greensboro, North Carolina 27401
    United States

    Active - Recruiting

  • K&R Research LLC

    Marion, Ohio 43302
    United States

    Active - Recruiting

  • Advanced Medical Research

    Maumee, Ohio 43537
    United States

    Active - Recruiting

  • K&R Research LLC

    Marion 5161902, Ohio 5165418 43302
    United States

    Site Not Available

  • K&R Research LLC - Internal Medicine

    Marion 5161902, Ohio 5165418 43302
    United States

    Active - Recruiting

  • Monument Health Clinical Research

    Rapid City, South Dakota 57701
    United States

    Active - Recruiting

  • Monument Health Clinical Research, A Department of Monument Health Rapid City Hospital, Inc

    Rapid City 5768233, South Dakota 5769223 57701
    United States

    Site Not Available

  • East Coast Institute for Research, Jefferson City

    Jefferson City, Tennessee 37760
    United States

    Active - Recruiting

  • East Coast Institute for Research - Cardiology

    Jefferson City 4632959, Tennessee 4662168 37760
    United States

    Active - Recruiting

  • East Coast Institute for Research, Jefferson City

    Jefferson City 4632959, Tennessee 4662168 37760
    United States

    Site Not Available

  • PharmaTex Research

    Amarillo, Texas 79106
    United States

    Active - Recruiting

  • Complete Heart Care P.A.

    McKinney, Texas 75071
    United States

    Active - Recruiting

  • Permian Research Foundation

    Odessa, Texas 79761
    United States

    Active - Recruiting

  • Tyler Cardiovascular Consultants

    Tyler, Texas 75701
    United States

    Active - Recruiting

  • PharmaTex Research

    Amarillo 5516233, Texas 4736286 79106
    United States

    Site Not Available

  • Permian Research Foundation

    Odessa 5527554, Texas 4736286 79761
    United States

    Site Not Available

  • Tyler Cardiovascular Consultants

    Tyler 4738214, Texas 4736286 75701
    United States

    Site Not Available

  • Alpine Research TC

    Clinton, Utah 84015
    United States

    Active - Recruiting

  • Alpine Research TC

    Clinton 5773001, Utah 5549030 84015
    United States

    Site Not Available

  • Alpine Research TC - Cardiology

    Clinton 5773001, Utah 5549030 84015
    United States

    Active - Recruiting

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