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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Regeneron Pharmaceuticals • ClinicalTrials.gov ID: NCT07430956

Registry updated: 2026-10-14
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Description

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)

Interventions

  • REGN7508 (Drug)
    Administered per the protocol
  • REGN9933 (Drug)
    Administered per the protocol
  • Placebo (Drug)
    Administered per the protocol

Eligibility criteria

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

Conditions

Atrial Fibrillation (AF)

Locations

  • SEC Clinical Research — Dothan, Alabama, United States
  • Sun City Clinical Research — Glendale, Arizona, United States
  • Arkansas Cardiology P.A. — Little Rock, Arkansas, United States
  • Mission Cardiovascular Research Institute — Fremont, California, United States
  • National Institute of California Heart and Vein Specialists — Huntington Beach, California, United States
  • Profound Research LLC at San Diego Cardiovascular Associates — La Jolla, California, United States
  • Valley Clinical Trials, LLC dba Flourish Research — Northridge, California, United States
  • Profound Research LLC at Southern California Heart Specialists — Pasadena, California, United States
  • FOMAT - Comprehensive Cardiovascular Care — Santa Maria, California, United States
  • Cardiology Associates Medical Group — Ventura, California, United States
  • Interventional Cardiology Medical Group — West Hills, California, United States
  • East Coast Institute for Research, Jacksonville — Jacksonville, Florida, United States
  • South Florida Research Organization LLC — Medley, Florida, United States
  • Sec Clinical Research — Pensacola, Florida, United States
  • Cardiovascular Center of Sarasota Foundation for Research and Education — Sarasota, Florida, United States
  • Clinical Site Partners, LLC DBA Flourish Research — Winter Park, Florida, United States
  • Atlanta Clinical Research Centers — Atlanta, Georgia, United States
  • NSC Research, Inc — Johns Creek, Georgia, United States
  • Franciscan Physician Network, Indiana Heart Physicians — Indianapolis, Indiana, United States
  • Indiana Medical Research — Merrillville, Indiana, United States
  • Profound Research, Powers Health Medical Group - Electrophysiology — Munster, Indiana, United States
  • Monroe Research, LLC — West Monroe, Louisiana, United States
  • Profound Research, Cardiology and Vascular Associates (CAVA) - Bloomfield Hills — Bloomfield Hills, Michigan, United States
  • Profound Research, Millennium Cardiology — Farmington Hills, Michigan, United States
  • Flint Clinical Research — Flint, Michigan, United States
  • AA Medical Research Center (MRC) — Flint, Michigan, United States
  • Jackson Heart Clinic — Jackson, Mississippi, United States
  • Super Health Pharmacy — Staten Island, New York, United States
  • Hawthorne Health, Moose Pharmacy of Concord — Concord, North Carolina, United States
  • K&R Research LLC — Marion, Ohio, United States
  • AnMed Health — Anderson, South Carolina, United States
  • Monument Health Clinical Research — Rapid City, South Dakota, United States
  • Tennessee Center for Clinical Trials — Tullahoma, Tennessee, United States
  • PharmaTex Research — Amarillo, Texas, United States
  • PanAmerican Clinical Research — Brownsville, Texas, United States
  • Southwest Family Medicine Associates — Dallas, Texas, United States
  • East Texas Cardiology — Houston, Texas, United States
  • Synergy Group Medical,LLC — Houston, Texas, United States
  • Synergy Groups Medical — Houston, Texas, United States
  • Heart Institute of East Texas — Lufkin, Texas, United States
  • Texas Institute of Cardiology PA — McKinney, Texas, United States
  • Synergy Group Medical, LLC — Missouri City, Texas, United States
  • Conquest Research — Vienna, Virginia, United States
  • Hamilton Medical Research Group (HMRG) — Hamilton, Ontario, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record