Suspended

LIBREXIA-AFMilvexian for Atrial Fibrillation Stroke Prevention

Study Aim

This Phase 3 study aims to evaluate whether Milvexian can effectively prevent stroke and systemic embolism in people with atrial fibrillation.

What is being tested

Milvexian

+ Placebo

+ Apixaban

Drug

Who is being recruted

Arrhythmias, Cardiac+3

+ Atrial Fibrillation

+ Cardiovascular Diseases

Over 18 Years

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: April 2023

See protocol details

Summary

Principal SponsorJanssen Research & Development, LLC

Last updated: March 14, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 11, 2023

Actual date on which the first participant was enrolled.

This study focuses on people with atrial fibrillation, a heart condition that can lead to an irregular and often rapid heart rate. The primary goal is to determine whether a new oral medication called milvexian is as effective as the existing drug, apixaban, in reducing the chances of having a stroke or a systemic embolism, a condition where a blood clot travels through the bloodstream and causes blockages outside the brain. This research is important because finding an effective treatment could significantly lower the risk of severe complications for those with atrial fibrillation. Participants in the study will be randomly assigned to receive either milvexian or apixaban. Both medications are taken orally, meaning participants will swallow them as pills. The study will closely monitor the time it takes for participants to experience their first stroke or systemic embolism event, if at all. The results will help determine whether milvexian can be a safe and effective alternative to apixaban, potentially offering a new treatment option for managing atrial fibrillation.

Official TitleA 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

NCT05757869

Principal SponsorJanssen Research & Development, LLC

Last updated: March 14, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

20284 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacAtrial FibrillationCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

4 inclusion criteria required to participate

Minimum age of 18 years

Medically stable and appropriate for chronic antithrombotic treatment

Atrial fibrillation eligible to receive anticoagulation

Participant must satisfy one or both of the following categories of risk factors (a or b): a) one or more of the following risk factors: i) age greater than or equal to 75 years, ii) history of any type of stroke including symptomatic stroke of any kind. b) two or more of the following risk factors: i) age between 65 and 74 years, ii) hypertension, iii) diabetes mellitus, iv) atherosclerotic vascular disease, v) heart failure

2 exclusion criteria prevent from participating

Hemodynamically significant valve disease or those with valve disease that will potentially require surgical valve replacement during the study

Any condition other than AF that requires chronic anticoagulation

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will receive milvexian 100 milligrams (mg) orally, twice daily and placebo that matches apixaban beginning on Day 1 through end of treatment (EOT). Participants after the EOT visit may have an option to receive open-label apixaban at the appropriate dose (5 mg or 2.5 mg, twice daily), for which the sponsor provides a 30-day supply.

Group II

Active Comparator

Participants will receive a placebo that matches milvexian and a capsule containing apixaban 5 mg or 2.5 mg orally, twice daily. Participants after the EOT visit may have an option to receive open-label apixaban (5 mg or 2.5 mg, twice daily) at the appropriate dose, for which the sponsor provides a 30-day supply.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1,041 locations

Suspended

Clearwater Cardiovascular Consultants

Largo, United StatesOpen Clearwater Cardiovascular Consultants in Google Maps

Suspended

Miami Clinical Research

Miami, United States

Suspended

Suncoast Research Associates, LLC

Miami, United States

Suspended

Ascension Sacred Heart Hospital

Miramar Beach, United States

Suspended1,041 Study Centers