Atrial Fibrillation (AF)
Conditions
Brief summary
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type) or systemic embolism, Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding or ISTH Clinically Relevant Non-Major (CRNM) bleeding
Detailed description
Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or ISTH CRNM bleeding, Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, or ISTH major bleeding, Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or all-cause death, Time to first occurrence of ISTH major bleeding, Time to first occurrence of hemorrhagic stroke, intracerebral hemorrhage, or hemorrhagic transformation of an ischemic stroke, Time to occurrence of fatal bleeding, Number of ISTH major bleeding events, Number of ISTH CRNM bleeding events, Number of minor bleeding events, Time to all-cause death, Occurrence of Treatment-Emergent Adverse Events (TEAEs), Severity of TEAEs, Occurrence of Anti-Drug Antibodies (ADA) to REGN7508, Magnitude of ADA to REGN7508
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type) or systemic embolism, Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding or ISTH Clinically Relevant Non-Major (CRNM) bleeding | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or ISTH CRNM bleeding, Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, or ISTH major bleeding, Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or all-cause death, Time to first occurrence of ISTH major bleeding, Time to first occurrence of hemorrhagic stroke, intracerebral hemorrhage, or hemorrhagic transformation of an ischemic stroke, Time to occurrence of fatal bleeding, Number of ISTH major bleeding events, Number of ISTH CRNM bleeding events, Number of minor bleeding events, Time to all-cause death, Occurrence of Treatment-Emergent Adverse Events (TEAEs), Severity of TEAEs, Occurrence of Anti-Drug Antibodies (ADA) to REGN7508, Magnitude of ADA to REGN7508 | — |