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

NCT07430956 · tracked via the Priya Life Science USA tracker

Sponsor

Regeneron Pharmaceuticals

Phase

Phase 3

Started

2026-04-03

Last updated

2026-09-17

Condition(s) studied

Atrial Fibrillation (AF)

Investigational drug(s) / intervention(s)

REGN7508REGN9933Placebo

REGN7508: Administered per the protocol

REGN9933: Administered per the protocol

Placebo: Administered per the protocol

Study summary

This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called "study drugs"). The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. When this happens, blood cannot move smoothly through the heart; it can slow down or pool in one spot, which can lead to the formation of blood clots.

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 effective and safe REGN7508 and REGN9933, individually, are in preventing ischemic stroke or systemic embolism in people with atrial fibrillation who cannot or may choose to not take blood thinners.

The study is looking at several other research questions, including:

* What side effects may happen from taking REGN7508 or REGN9933
* How well does REGN7508 or REGN9933 lower the risk of having an ischemic stroke and/or systemic embolism compared to the placebo
* How well does REGN7508 or REGN9933 lower the risk of having a major health problem affecting heart and blood circulation compared to placebo
* How well does REGN7508 or REGN9933 lower the risk of death compared to placebo
* How much REGN7508 or REGN9933 is in the blood at different times
* Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the study 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 considered to be secondary to a reversible cause 2. At moderate to high risk for stroke defined as: 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 ≥4 OR 2. CHA2DS2-VA score of 3 AND at least 1 enrichment criteria as described in the protocol 3. Shared decision making between the participant and provider determining that the bleeding risk of Oral Anticoagulant (OAC) therapy outweighs the benefits, making the participant unsuitable for OAC therapy as described in the protocol Key Exclusion Criteria: 1. Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion) 2. Had an ischemic stroke within 2 days prior to randomization 3. Has persistent, uncontrolled hypertension (per investigator's discretion) 4. Has a history of Central Nervous System (CNS) bleeding within 30 days prior to randomization 5. Has a life expectancy less than 12 months 6. Has participated in a prior Factor XI (FXI) inhibitor study Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Primary outcome measure(s)

Time to first occurrence of ischemic stroke or systemic embolism — Up to 36 months
Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding — Up to 36 months

Trial sites (35)

Facility	City	Region	Status
SEC Clinical Research	Dothan	Alabama	Recruiting
Arkansas Cardiology P.A.	Little Rock	Arkansas	Recruiting
Mission Cardiovascular Research Institute	Fremont	California	Recruiting
National Institute of California Heart and Vein Specialists	Huntington Beach	California	Recruiting
Profound Research LLC at San Diego Cardiovascular Associates	La Jolla	California	Recruiting
Profound Research LLC at Southern California Heart Specialists	Pasadena	California	Recruiting
Cardiology Associates Medical Group	Ventura	California	Recruiting
Interventional Cardiology Medical Group	West Hills	California	Recruiting
South Florida Research Organization LLC	Medley	Florida	Recruiting
Sec Clinical Research	Pensacola	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
Atlanta Clinical Research Centers	Atlanta	Georgia	Recruiting
NSC Research, Inc	Johns Creek	Georgia	Recruiting
Indiana Medical Research	Merrillville	Indiana	Recruiting
Monroe Research, LLC	West Monroe	Louisiana	Recruiting
Profound Research, Cardiology and Vascular Associates (CAVA) - Bloomfield Hills	Bloomfield Hills	Michigan	Recruiting
Profound Research, Millennium Cardiology	Farmington Hills	Michigan	Recruiting
AA Medical Research Center (MRC)	Flint	Michigan	Recruiting
Super Health Pharmacy	Staten Island	New York	Recruiting
Hawthorne Health, Moose Pharmacy of Concord	Concord	North Carolina	Recruiting
K&R Research LLC	Marion	Ohio	Recruiting
AnMed Health	Anderson	South Carolina	Recruiting
Monument Health Clinical Research	Rapid City	South Dakota	Recruiting
Tennessee Center for Clinical Trials	Tullahoma	Tennessee	Recruiting
PharmaTex Research	Amarillo	Texas	Recruiting
PanAmerican Clinical Research	Brownsville	Texas	Recruiting
Southwest Family Medicine Associates	Dallas	Texas	Recruiting
East Texas Cardiology	Houston	Texas	Recruiting
Synergy Group Medical,LLC	Houston	Texas	Recruiting
Synergy Groups Medical	Houston	Texas	Recruiting
Heart Institute of East Texas	Lufkin	Texas	Recruiting
Texas Institute of Cardiology PA	McKinney	Texas	Recruiting
Synergy Group Medical, LLC	Missouri City	Texas	Recruiting
Conquest Research	Vienna	Virginia	Recruiting

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Other trials for the same condition

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

Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation 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 NCT07430956 on ClinicalTrials.gov ↗ ← All trials in the USA