Actively Recruiting
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable
Led by Regeneron Pharmaceuticals · Updated on 2026-04-29
2628
Participants Needed
5
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has atrial fibrillation or atrial flutter (paroxysmal or persistent) not caused by a reversible condition
- Has moderate to high risk for stroke with CHA2DS2-VA score 4 or higher OR score 3 with additional criteria
- Shared decision that risk of bleeding from blood thinners is higher than benefits, making oral anticoagulants unsuitable
You will not qualify if you...
- Has a mechanical heart valve prosthesis (transcatheter aortic valve replacement allowed)
- Had an ischemic stroke within 2 days before randomization
- Has persistent, uncontrolled high blood pressure
- History of central nervous system bleeding within 30 days before randomization
- Life expectancy less than 12 months
- Has participated in a previous Factor XI inhibitor study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
SEC Clinical Research
Dothan, Alabama, United States, 36305
Actively Recruiting
2
Profound Research LLC at Southern California Heart Specialists
Pasadena, California, United States, 91105
Actively Recruiting
3
Cardiology Associates Medical Group
Ventura, California, United States, 93003
Actively Recruiting
4
AA Medical Research Center (MRC)
Flint, Michigan, United States, 48504
Actively Recruiting
5
K&R Research LLC
Marion, Ohio, United States, 43302
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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