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A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants with Atrial Fibrillation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501419-15-00
Acronym
70033093AFL3002
Enrollment
8867
Registered
2023-08-07
Start date
2023-08-23
Completion date
Unknown
Last updated
2025-10-29

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

Conditions

Atrial Fibrillation

Brief summary

Time to the first occurrence of composite endpoint of stroke and non-CNS systemic embolism

Detailed description

• Time to the first occurrence of ISTH major bleeding • Time to the first occurrence of the composite of ISTH major and CRNM bleeding, Time to the first occurrence of composite endpoint of stroke, non-CNS systemic embolism, and ISTH major bleeding., Time to the first occurrence of composite endpoint of CV death, MI, stroke, and non-CNS systemic embolism., Time to CV death, Time to the first occurrence of composite endpoint of all-cause death, MI, stroke and non-CNS systemic embolism., Time to the first occurrence of composite endpoint of CV death, MI, stroke, acute limb ischemia (ALI [any unanticipated revascularization or amputation of ischemic limb]), and urgent hospitalization for vascular cause of ischemic nature (including DVT and PE).

Interventions

Sponsors

Janssen - Cilag International
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to the first occurrence of composite endpoint of stroke and non-CNS systemic embolism

Secondary

MeasureTime frame
• Time to the first occurrence of ISTH major bleeding • Time to the first occurrence of the composite of ISTH major and CRNM bleeding, Time to the first occurrence of composite endpoint of stroke, non-CNS systemic embolism, and ISTH major bleeding., Time to the first occurrence of composite endpoint of CV death, MI, stroke, and non-CNS systemic embolism., Time to CV death, Time to the first occurrence of composite endpoint of all-cause death, MI, stroke and non-CNS systemic embolism., Time to the first occurrence of composite endpoint of CV death, MI, stroke, acute limb ischemia (ALI [any unanticipated revascularization or amputation of ischemic limb]), and urgent hospitalization for vascular cause of ischemic nature (including DVT and PE).

Countries

Belgium, Bulgaria, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026