Recruiting
Phase 3

REGN7508 vs. Apixaban

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07626411

Conditions

Atrial Fibrillation (AF)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

REGN7508

Apixaban

Placebo

Study Details

Brief 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)

Conditions

Atrial Fibrillation (AF)

Study ID

NCT07626411

Start date

Aug 10, 2026

Status verified date

Oct, 2026

Completion date

Dec 10, 2029

Anticipated

Primary completion date

Sep 11, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15364 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: REGN7508 + Placebo

active comparator: Apixaban + Placebo

Interventions

REGN7508

Administered per the protocol

Apixaban

Administered per the protocol

Placebo

Administered per the protocol

Primary outcome measure

  • Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type) or systemic embolism [ Time Frame: Approximately 36 months ]
  • Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding or ISTH Clinically Relevant Non-Major (CRNM) bleeding [ Time Frame: Approximately 36 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Advanced Cardiovascular

Recruiting

Alexander City, Alabama, United States, 35010

SEC Clinical Research

Recruiting

Dothan, Alabama, United States, 36305

Eastern Shore Research Institute

Recruiting

Fairhope, Alabama, United States, 36532

Sun City Clinical Research

Recruiting

Glendale, Arizona, United States, 85351

Arkansas Cardiology P.A.

Recruiting

Little Rock, Arkansas, United States, 72205

Mission Cardiovascular Research Institute

Recruiting

Fremont, California, United States, 94538

National Institute of California Heart and Vein Specialists

Recruiting

Huntington Beach, California, United States, 92648

Profound Research LLC at San Diego Cardiovascular Associates

Recruiting

La Jolla, California, United States, 92037

Radin Cardiovascular Medical Group

Recruiting

Newport Beach, California, United States, 92663

Valley Clinical Trials, LLC dba Flourish Research

Recruiting

Northridge, California, United States, 91325

Southern California Heart Specialists

Recruiting

Pasadena, California, United States, 91105

FOMAT - Comprehensive Cardiovascular Care

Recruiting

Santa Maria, California, United States, 93454

Cardiology Associates Medical Group

Recruiting

Ventura, California, United States, 93003

Interventional Cardiology Medical Group

Recruiting

West Hills, California, United States, 91307

Nouvelle Clinical Research LLC

Recruiting

Cutler Bay, Florida, United States, 33189

South Florida Research Organization LLC

Recruiting

Medley, Florida, United States, 33166

Healix Clinical Research

Recruiting

New Smyrna Beach, Florida, United States, 32168

Sec Clinical Research

Recruiting

Pensacola, Florida, United States, 32503

Flourish Research, St. Johns Center for Clinical Research

Recruiting

Saint Augustine, Florida, United States, 32086

Cardiovascular Center of Sarasota Foundation for Research and Education

Recruiting

Sarasota, Florida, United States, 34239

Clinical Site Partners, LLC DBA Flourish Research

Recruiting

Winter Park, Florida, United States, 32789

Atlanta Clinical Research Centers

Recruiting

Atlanta, Georgia, United States, 30342

NSC Research, Inc

Recruiting

Johns Creek, Georgia, United States, 30024

Cardiovascular Research of Northwest Indiana, LLC

Recruiting

Munster, Indiana, United States, 46321-4054

Profound Research, Powers Health Medical Group - Electrophysiology

Recruiting

Munster, Indiana, United States, 46321

Monroe Research, LLC

Recruiting

West Monroe, Louisiana, United States, 71291

Anderson Medical Research

Recruiting

Ft. Washington, Maryland, United States, 20744

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

Recruiting

Bloomfield Hills, Michigan, United States, 48304

Profound Research, Millennium Cardiology

Recruiting

Farmington Hills, Michigan, United States, 48334

Super Health Pharmacy

Recruiting

Staten Island, New York, United States, 10309

Hawthorne Health, Moose Pharmacy of Concord

Recruiting

Concord, North Carolina, United States, 28025

Peters Medical Research

Recruiting

High Point, North Carolina, United States, 27260

K&R Research LLC

Recruiting

Marion, Ohio, United States, 43302

Tennessee Center for Clinical Trials

Recruiting

Tullahoma, Tennessee, United States, 37388

PharmaTex Research

Recruiting

Amarillo, Texas, United States, 79106

PanAmerican Clinical Research

Recruiting

Brownsville, Texas, United States, 78520

Synergy Groups Medical

Recruiting

Houston, Texas, United States, 77061

West Houston Area Clinical Trial Consultants, LLC

Recruiting

Houston, Texas, United States, 77094

Synergy Group Medical, LLC

Recruiting

Missouri City, Texas, United States, 77459

Permian Research Foundation

Recruiting

Odessa, Texas, United States, 79761

Tyler Cardiovascular Consultants

Recruiting

Tyler, Texas, United States, 75701

Alpine Research TC

Recruiting

Clinton, Utah, United States, 84015

Carient Heart & Vascular

Recruiting

Manassas, Virginia, United States, 20109

Conquest Research

Recruiting

Vienna, Virginia, United States, 22182

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Keywords

  • Bleeding
  • Stroke
  • Systemic embolism
  • Blood clots

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.