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A Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention with REGN7508, a Monoclonal Antibody Against Factor XI, Versus Apixaban in Participants with Atrial Fibrillation (ROXI-EVEREST)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521617-97-00
Enrollment
1551
Registered
2026-09-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF)

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

Regeneron Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 1, 2026