NCT05754957Recruiting

A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome

Name: Clinical Trial NCT05754957
Creator: Janssen Research & Development, LLC
Keywords: Acute Coronary Syndrome, Milvexian, Phase 3, drug, clinical trial, United States of America

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

Janssen Research & Development, LLCPhase 3ClinicalTrials.govdrug

Verified

Study focus

Disease/Condition: Acute Coronary Syndrome
Drug/Device/Intervention: Milvexian
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Janssen Research & Development, LLC
Location: Alexander City,Cartersville,Alexandria,Slidell,Lenoir,Anderson,Amarillo,Houston, United States of America

Timeline & enrollment

Phase: Phase 3
Start date: Apr 07, 2023
End date: Oct 20, 2026
Enrollment: 16000 participants

Primary outcome

Time to First Occurrence of Major Adverse Cardiovascular Event (MACE)

Summary

The purpose of this study is to evaluate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the composite of cardiovascular [CV] death, myocardial infarction [MI], and ischemic stroke).

ICD-10 classifications

Acute myocardial infarctionAcute myocardial infarction, unspecifiedAcute subendocardial myocardial infarctionAcute ischaemic heart disease, unspecifiedOther acute ischaemic heart diseases

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05754957
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05754957 through Pure Global AI's free database. This Phase 3 trial is sponsored by Janssen Research & Development, LLC and is currently Recruiting. The study focuses on Acute Coronary Syndrome. Target enrollment is 16000 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.