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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,628
Time to first occurrence of ischemic stroke or systemic embolism
Time frame: Up to 36 months
Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding
Time frame: Up to 36 months
Time to first occurrence of Major Adverse Cardiovascular Event (MACE)
Time frame: Up to 36 months
Time to first occurrence of MACE, pulmonary embolism, or Venous Thromboembolism (VTE)
Time frame: Up to 36 months
Time to first occurrence of ischemic stroke
Time frame: Up to 36 months
Time to Cardiovascular (CV) death
Time frame: Up to 36 months
Time to all-cause death
Time frame: Up to 36 months
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 39 months
Severity of TEAEs
Time frame: Up to 39 months
Concentrations of REGN7508 over time
Time frame: Up to 36 months
Concentrations of REGN9933 over time
Time frame: Up to 36 months
Change from baseline in activated Partial Thromboplastin Time (aPTT) over time
Time frame: Up to approximately 9 weeks
Change from baseline in Prothrombin time (PT)/International Normalized Ratio (INR) over time
Time frame: Up to approximately 9 weeks
Occurrence of Anti-Drug Antibody (ADA) to REGN7508 over time
Time frame: Up to 36 months
Magnitude of ADA to REGN7508 over time
Time frame: Up to 36 months
Occurrence of ADA to REGN9933 over time
Time frame: Up to 36 months
Magnitude of ADA to REGN9933 over time
Time frame: Up to 36 months
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