Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation

What this study is about

This study is researching experimental drugs called REGN7508 and REGN9933. The study is focused on participants who have atrial fibrillation, which means that the heart beats too fast and unevenly. 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 well REGN7508 and REGN9933 work in patients that get medicine for their atrial fibrillation. The bleeding effects of REGN7508 and REGN9933 will be compared to another medicine (apixaban), which is available on the market to treat and prevent formation of blood clots. The study is looking at several other research questions, including: * What side effects may happen from taking REGN7508 or REGN9933 * How well do the study drugs reduce the risk of having a stroke * How much of REGN7508 or REGN9933 is in the blood at different times * Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the drugs less effective or could lead to side effects)

Who can join (things the study team will check)

✅ You may be able to join if…

• Has AF or flutter (paroxysmal or persistent), not felt to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol
• Meets one of the following:
  • CHA2DS2-VA [C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Thromboembolism (double points); V: Vascular disease; A: Age 65-74 years] score ≥2 and Oral Anticoagulant (OAC) naïve or
  • CHA2DS2-VA score ≥3 or
  • CHA2DS2-VA score of 2 and at least 1 enrichment criteria as described in the protocol
• Must have an International Normalization Ratio (INR) <2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)

🚫 You may not be able to join if…

• Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)
• Has known moderate-to-severe mitral stenosis
• Has had successful ablation therapy or Left Atrial Appendage (LAA) occlusion/exclusion, or planned ablation or LAA occlusion/exclusion as described in the protocol
• Had an ischemic stroke within 2 days prior to randomization
• Has estimated Glomerular Filtration Rate (eGFR) <15 mL/min/1.73m\^2 within 30 days prior to randomization or on dialysis or expected to be started as described in the protocol
• Has a history of central nervous system bleeding within 30 days prior to randomization Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Where this trial is running

• SEC Clinical Research, Dothan, Alabama, United States
• Eastern Shore Research Institute, Fairhope, Alabama, United States
• Valley Clinical Trials, Inc, Covina, California, United States
• North Coast Cardiology, Encinitas, California, 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 Southern California Heart Specialists, Pasadena, California, United States
• Empire Clinical Research, Pomona, California, United States
• Northbay Clinical Research Center, Santa Rosa, California, United States
• Cardiology Associates Medical Group, Ventura, California, United States
• Interventional Cardiology Medical Group, West Hills, California, United States
• Nouvelle Clinical Research LLC, Cutler Bay, Florida, United States

+ 47 more sites.

Who to contact

Clinical Trials Administrator · 844-734-6643 · clinicaltrials@regeneron.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07175428.