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

NCT07175428 · tracked via the Priya Life Science USA tracker

Sponsor

Regeneron Pharmaceuticals

Phase

Phase 2

Started

2025-10-20

Last updated

2026-09-15

Condition(s) studied

Atrial Fibrillation (AF)

Investigational drug(s) / intervention(s)

REGN7508REGN9933Apixaban

REGN7508: Administered per the protocol

REGN9933: Administered per the protocol

Apixaban: Administered per the protocol

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Incidence of any bleeding — 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

Trial sites (81)

Facility	City	Region	Status
SEC Clinical Research	Dothan	Alabama	Recruiting
Eastern Shore Research Institute	Fairhope	Alabama	Recruiting
Valley Clinical Trials, Inc	Covina	California	Recruiting
North Coast Cardiology	Encinitas	California	Recruiting
Mission Cardiovascular Research Institute	Fremont	California	Recruiting
National Institute of California Heart and Vein Specialists	Huntington Beach	California	Recruiting
Profound Research LLC at Southern California Heart Specialists	Pasadena	California	Recruiting
Empire Clinical Research	Pomona	California	Recruiting
The Cardiovascular Center	Redding	California	Recruiting
Northbay Clinical Research Center	Santa Rosa	California	Recruiting
Cardiology Associates Medical Group	Ventura	California	Recruiting
Interventional Cardiology Medical Group	West Hills	California	Recruiting
Nouvelle Clinical Research LLC	Cutler Bay	Florida	Recruiting
South Florida Research Organization LLC	Medley	Florida	Recruiting
Inpatient Research Clinic LLC	Miami Lakes	Florida	Recruiting
Cardiovascular Center of Sarasota Foundation for Research and Education	Sarasota	Florida	Recruiting
Clinical Site Partners, LLC DBA Flourish Research	Winter Park	Florida	Recruiting
Grady Health System	Atlanta	Georgia	Recruiting
Health Sciences Research Building II	Atlanta	Georgia	Withdrawn
NSC Research, Inc	Johns Creek	Georgia	Recruiting
Indiana University	Indianapolis	Indiana	Recruiting
Blue Coast Research Center, LLC	Indianapolis	Indiana	Recruiting
Franciscan Physician Network, Indiana Heart Physicians	Indianapolis	Indiana	Recruiting
Indiana Medical Research	Merrillville	Indiana	Recruiting
Reid Physician Associates	Richmond	Indiana	Recruiting
Monroe Research, LLC	West Monroe	Louisiana	Recruiting
Anderson Medical Research	Ft. Washington	Maryland	Recruiting
Beth Israel Lahey Health, Beth Israel Deaconess Medical Center (BIDMC)	Boston	Massachusetts	Recruiting
Profound Research, Millennium Cardiology	Farmington Hills	Michigan	Recruiting
AA Medical Research Center (MRC)	Flint	Michigan	Recruiting
Fairview Health Services	Maplewood	Minnesota	Recruiting
Moses Cone Hospital Operating Corporation dba Cone Health, Lebauer-Brodie Center for Cardiovascular Research	Greensboro	North Carolina	Recruiting
K&R Research LLC	Marion	Ohio	Recruiting
Advanced Medical Research	Maumee	Ohio	Recruiting
Monument Health Clinical Research	Rapid City	South Dakota	Recruiting
East Coast Institute for Research, Jefferson City	Jefferson City	Tennessee	Recruiting
PharmaTex Research	Amarillo	Texas	Recruiting
Complete Heart Care P.A.	McKinney	Texas	Recruiting
Texas Institute of Cardiology PA	McKinney	Texas	Recruiting
Synergy Group Medical, LLC	Missouri City	Texas	Recruiting

+ 41 more sites — see the full list on the official registry below.

On this site

📄 Eliquis (apixaban) drug profile →

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Other trials for the same condition

Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable Recruiting

EPX-HTG for Structural Heart Procedures Starting soon

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study Recruiting

Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation Recruiting

Detection of Atrial Fibrillation Using PPG From Smartphone Cameras Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07175428 on ClinicalTrials.gov ↗ ← All trials in the USA