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Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable
Sponsor: Regeneron Pharmaceuticals
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)
Official title: A Master Protocol for a Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention With REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, Versus Placebo in Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable (ROXI-INCLINE)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2628
Start Date
2026-04-03
Completion Date
2029-06-26
Last Updated
2026-09-17
Healthy Volunteers
No
Conditions
Interventions
REGN7508
Administered per the protocol
REGN9933
Administered per the protocol
Placebo
Administered per the protocol
Locations (35)
SEC Clinical Research
Dothan, Alabama, 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
Profound Research LLC at Southern California Heart Specialists
Pasadena, California, United States
Cardiology Associates Medical Group
Ventura, California, United States
Interventional Cardiology Medical Group
West Hills, California, 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
Indiana Medical Research
Merrillville, 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
AA Medical Research Center (MRC)
Flint, Michigan, 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