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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,200
Administered per the protocol
Administered per the protocol
Administered per the protocol
SEC Clinical Research
Dothan, Alabama, United States
RECRUITINGEastern Shore Research Institute
Fairhope, Alabama, United States
RECRUITINGValley Clinical Trials, Inc
Covina, California, United States
RECRUITINGNorth Coast Cardiology
Encinitas, California, United States
Incidence of any bleeding
Defined as the composite of International Society on Thrombosis and Haemostasis (ISTH) major bleeding, ISTH Clinically Relevant Non-Major (CRNM) bleeding, or minor bleeding
Time frame: 12 weeks
Incidence of the composite of ISTH major bleeding or ISTH CRNM bleeding
Time frame: 12 weeks
Incidence of ISTH major bleeding
Time frame: 12 weeks
Incidence of ISTH CRNM bleeding
Time frame: 12 weeks
Incidence of minor bleeding
Time frame: 12 weeks
Number of ISTH major bleeding events
Time frame: 12 weeks
Number of ISTH CRNM bleeding events
Time frame: 12 weeks
Number of minor bleeding events
Time frame: 12 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Approximately 25 weeks
Severity of TEAEs
Time frame: Approximately 25 weeks
Incidence of the composite of stroke or systemic embolism
Time frame: Approximately 12 weeks
Incidence of Antidrug Antibodies (ADA) to REGN7508
Time frame: 12 weeks
Magnitude of ADA to REGN7508
Time frame: 12 weeks
Incidence of ADA to REGN9933
Time frame: 12 weeks
Magnitude of ADA to REGN9933
Time frame: 12 weeks
Concentrations of REGN7508
Time frame: Approximately 25 weeks
Concentrations of REGN9933
Time frame: Approximately 25 weeks
Change from baseline in activated Partial Thromboplastin Time (aPTT)
Time frame: Approximately 25 weeks
Change from baseline in Prothrombin Time (PT)
Time frame: Approximately 25 weeks
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Mission Cardiovascular Research Institute
Fremont, California, United States
RECRUITINGNational Institute of California Heart and Vein Specialists
Huntington Beach, California, United States
RECRUITINGProfound Research LLC at Southern California Heart Specialists
Pasadena, California, United States
RECRUITINGEmpire Clinical Research
Pomona, California, United States
RECRUITINGThe Cardiovascular Center
Redding, California, United States
RECRUITINGNorthbay Clinical Research Center
Santa Rosa, California, United States
RECRUITING...and 71 more locations