This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called apixaban. The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. The aim of the study is to see how safe and effective REGN7508 is in preventing stroke and/or systemic embolism in participants with atrial fibrillation and how it compares against participants that will receive apixaban in this study. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
15,364
Administered per the protocol
Administered per the protocol
Administered per the protocol
Advanced Cardiovascular
Alexander City, Alabama, United States
RECRUITINGSEC Clinical Research
Dothan, Alabama, United States
RECRUITINGSun City Clinical Research
Glendale, Arizona, United States
RECRUITINGMission Cardiovascular Research Institute
Fremont, California, United States
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type) or systemic embolism
Time frame: Approximately 36 months
Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding or ISTH Clinically Relevant Non-Major (CRNM) bleeding
Time frame: Approximately 36 months
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or ISTH CRNM bleeding
Time frame: Approximately 36 months
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, or ISTH major bleeding
Time frame: Approximately 36 months
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or all-cause death
Time frame: Approximately 36 months
Time to first occurrence of ISTH major bleeding
Time frame: Approximately 36 months
Time to first occurrence of hemorrhagic stroke, intracerebral hemorrhage, or hemorrhagic transformation of an ischemic stroke
Time frame: Approximately 36 months
Time to occurrence of fatal bleeding
Time frame: Approximately 36 months
Number of ISTH major bleeding events
Time frame: Approximately 36 months
Number of ISTH CRNM bleeding events
Time frame: Approximately 36 months
Number of minor bleeding events
Time frame: Approximately 36 months
Time to all-cause death
Time frame: Approximately 36 months
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Approximately 39 months
Severity of TEAEs
Time frame: Approximately 39 months
Occurrence of Anti-Drug Antibodies (ADA) to REGN7508
Time frame: Approximately 36 months
Magnitude of ADA to REGN7508
Time frame: Approximately 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Profound Research LLC at San Diego Cardiovascular Associates
La Jolla, California, United States
RECRUITINGRadin Cardiovascular Medical Group
Newport Beach, California, United States
RECRUITINGValley Clinical Trials, LLC dba Flourish Research
Northridge, California, United States
RECRUITINGSouthern California Heart Specialists
Pasadena, California, United States
RECRUITINGCardiology Associates Medical Group
Ventura, California, United States
RECRUITINGInterventional Cardiology Medical Group
West Hills, California, United States
RECRUITING...and 22 more locations