A Phase 3, Randomized, Double-Blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501418-69-00

Acronym

70033093ACS3003

Enrollment

8535

Registered

2023-08-01

Start date

2023-11-21

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Acute Coronary Syndrome

Brief summary

Time to the first occurrence of MACE

Detailed description

Time to the first occurrence of MAVE, Time to the first occurrence of ACM, MI, and ischemic stroke, Time to CV death, Time to ACM

Interventions

DRUGACETYLSALICYLIC ACID

DRUGJNJ-70033093

DRUGCLOPIDOGREL

DRUGPRASUGREL

DRUGTICAGRELOR

DRUGMilvexian Matching Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to the first occurrence of MACE	—

Secondary

Measure	Time frame
Time to the first occurrence of MAVE, Time to the first occurrence of ACM, MI, and ischemic stroke, Time to CV death, Time to ACM	—

Countries

Austria, 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