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Purpose

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)

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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)

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
REGN7508
  • Drug: REGN7508
    Administered per the protocol
    Other names:
    • cenvacibart
Experimental
REGN9933
  • Drug: REGN9933
    Administered per the protocol
    Other names:
    • amrecibart
Active Comparator
Apixaban
  • Drug: Apixaban
    Administered per the protocol
    Other names:
    • Eliquis

Recruiting Locations

SEC Clinical Research
Dothan, Alabama 36305

Eastern Shore Research Institute
Fairhope, Alabama 36532

Valley Clinical Trials, Inc
Covina, California 91723

North Coast Cardiology
Encinitas, California 92024

Mission Cardiovascular Research Institute
Fremont, California 94538

National Institute of California Heart and Vein Specialists
Huntington Beach, California 92648

Profound Research LLC at Southern California Heart Specialists
Pasadena, California 91105

Empire Clinical Research
Pomona, California 91767

Northbay Clinical Research Center
Santa Rosa, California 95405

Cardiology Associates Medical Group
Ventura, California 93003

Interventional Cardiology Medical Group
West Hills, California 91307

Nouvelle Clinical Research LLC
Cutler Bay, Florida 33189

South Florida Research Organization LLC
Medley, Florida 33166

Inpatient Research Clinic LLC
Miami Lakes, Florida 33014

Cardiovascular Center of Sarasota Foundation for Research and Education
Sarasota, Florida 34239

Clinical Site Partners, LLC DBA Flourish Research
Winter Park, Florida 32789

Health Sciences Research Building II
Atlanta, Georgia 30322

NSC Research, Inc
Johns Creek, Georgia 30024

Indiana University
Indianapolis, Indiana 46202

Blue Coast Research Center, LLC
Indianapolis, Indiana 46237

Franciscan Physician Network, Indiana Heart Physicians
Indianapolis, Indiana 46237

Indiana Medical Research
Merrillville, Indiana 46410

Reid Physician Associates
Richmond, Indiana 47374

Monroe Research, LLC
West Monroe, Louisiana 71291

Anderson Medical Research
Ft. Washington, Maryland 20744

Beth Israel Lahey Health, Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts 02215

Profound Research, Millennium Cardiology
Farmington Hills, Michigan 48334

AA Medical Research Center (MRC)
Flint, Michigan 48504

Fairview Health Services
Maplewood, Minnesota 55109

Moses Cone Hospital Operating Corporation dba Cone Health, Lebauer-Brodie Center for Cardiovascular Research
Greensboro, North Carolina 27401

K&R Research LLC
Marion, Ohio 43302

Advanced Medical Research
Maumee, Ohio 43537

Monument Health Clinical Research
Rapid City, South Dakota 57701

East Coast Institute for Research, Jefferson City
Jefferson City, Tennessee 37760

PharmaTex Research
Amarillo, Texas 79106

Complete Heart Care P.A.
McKinney, Texas 75071

Permian Research Foundation
Odessa, Texas 79761

Tyler Cardiovascular Consultants
Tyler, Texas 75701

Alpine Research TC
Clinton, Utah 84015

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.