Trial Profile

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: Discontinued

Phase of Trial: Phase III

Latest Information Update: 10 Mar 2026

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At a glance

Drugs Milvexian (Primary) ; Clopidogrel; Prasugrel; Salicylic acid; Ticagrelor
Indications Myocardial infarction; Stroke
Focus Registrational; Therapeutic Use
Acronyms Librexia ACS
Sponsors Janssen Research & Development

14 Nov 2025 According to a Bristol Myers Squibb media release, company announced the decision to stop the Phase 3 Librexia ACS trial .The decision to discontinue the trial follows a preplanned interim analysis by the Independent Data Monitoring Committee (IDMC), which determined the trial is unlikely to meet the primary efficacy endpoint.
14 Nov 2025 Status changed from recruiting to discontinued.
19 Sep 2024 Planned End Date changed from 19 Oct 2026 to 9 Dec 2026.

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