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Recruiting Phase 3

Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation

NCT07626411 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2026-08-10
Last updated
2026-10-26

Condition(s) studied

Atrial Fibrillation (AF)

Investigational drug(s) / intervention(s)

REGN7508 →Apixaban →Placebo

REGN7508: Administered per the protocol

Apixaban: Administered per the protocol

Placebo: Administered per the protocol

Study 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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type) or systemic embolism — 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 — Approximately 36 months

Trial sites (54)

FacilityCityRegionStatus
Advanced Cardiovascular Alexander City Alabama Recruiting
SEC Clinical Research Dothan Alabama Recruiting
Eastern Shore Research Institute Fairhope Alabama Recruiting
Sun City Clinical Research Glendale Arizona Recruiting
Scottsdale Clinical Trials Scottsdale Arizona 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
Radin Cardiovascular Medical Group Newport Beach California Recruiting
Valley Clinical Trials, LLC dba Flourish Research Northridge California Recruiting
Southern California Heart Specialists Pasadena California Recruiting
FOMAT - Comprehensive Cardiovascular Care Santa Maria California Recruiting
Cardiology Associates Medical Group Ventura California Recruiting
Interventional Cardiology Medical Group West Hills California Recruiting
Excel Medical Clinical Trials, dba Flourish Research Boca Raton Florida Recruiting
Nouvelle Clinical Research LLC Cutler Bay Florida Recruiting
Nature Coast Clinical Research - Inverness Inverness Florida Recruiting
South Florida Research Organization LLC Medley Florida Recruiting
Healix Clinical Research New Smyrna Beach Florida Recruiting
Sec Clinical Research Pensacola Florida Recruiting
Flourish Research, St. Johns Center for Clinical Research Saint Augustine 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
Cardiovascular Research of Northwest Indiana, LLC Munster Indiana Recruiting
Profound Research, Powers Health Medical Group - Electrophysiology Munster Indiana Recruiting
Monroe Research, LLC West Monroe Louisiana Recruiting
Anderson Medical Research Ft. Washington Maryland Recruiting
Profound Research, Cardiology and Vascular Associates (CAVA) - Bloomfield Hills Bloomfield Hills Michigan Recruiting
Profound Research, Millennium Cardiology Farmington Hills Michigan Recruiting
Super Health Pharmacy Staten Island New York Recruiting
Hawthorne Health, Moose Pharmacy of Concord Concord North Carolina Recruiting
Peters Medical Research High Point North Carolina Recruiting
K&R Research LLC Marion Ohio Recruiting
Advanced Medical Research Maumee Ohio Recruiting
K2 Medical Research Providence East Providence Rhode Island Recruiting
Tennessee Center for Clinical Trials Tullahoma Tennessee Recruiting
PharmaTex Research Amarillo Texas Recruiting

+ 14 more sites — see the full list on the official registry below.

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 NCT07626411 on ClinicalTrials.gov ↗ ← All trials in the USA