Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05757869

A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation

The purpose of this study is to evaluate if milvexian is at least as effective as apixaban for reducing the risk of the composite stroke and non-central nervous system (CNS) systemic embolism.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto de Investigaciones Clinicas Bahia Blanca, Bahía Blanca, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Milvexian

Drug

Milvexian will be administered orally.

Apixaban

Drug

Apixaban will be administered orally.

Placebo

Drug

Milvexian matching milvexian placebo will be administered orally.

Apixaban Placebo

Drug

Apixaban matching apixaban placebo will be administered orally.

Primary outcomes

  1. Time to the First Occurrence of Composite Endpoint of Stroke and Non-central nervous system (CNS) Systemic Embolism

    Time frame: Up to 4 years

    Time to the first occurrence of composite endpoint of stroke and non-CNS systemic embolism will be reported.

Secondary outcomes

  1. Time to the First Occurrence of International Society of Thrombosis and Hemostasis (ISTH) Major Bleeding

    Time frame: Up to 4 years

    Time to the first occurrence of ISTH major bleeding will be reported.

  2. Time to the First Occurrence of the Composite of ISTH Major and Clinically Relevant Non-major (CRNM) Bleeding

    Time frame: Up to 4 years

    Time to the first occurrence of the composite of ISTH major and CRNM bleeding will be reported.

  3. Time to the First Occurrence of Composite Endpoint of Stroke, Non-CNS Systemic Embolism and ISTH Major Bleeding

    Time frame: Up to 4 years

    Time to the first occurrence of composite endpoint of stroke, non-CNS systemic embolism and ISTH major bleeding will be reported.

  4. Time to the First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, and Non-CNS Systemic Embolism

    Time frame: Up to 4 years

    Time to the first occurrence of composite endpoint of CV death, MI, stroke, and non-CNS systemic embolism will be reported.

  5. Time to CV Death

    Time frame: Up to 4 years

    Time to CV death will be reported.

  6. Time to the First Occurrence of Composite Endpoint of All-cause Death, MI, Stroke and Non-CNS Systemic Embolism

    Time frame: Up to 4 years

    Time to the first occurrence of composite endpoint of all-cause death, MI, stroke and Non-CNS systemic embolism will be reported.

  7. Time to the First Occurrence of Composite Endpoint of CV Death, MI, Stroke, Acute Limb Ischemia (ALI), and Urgent Hospitalization for Vascular cause of Ischemic Nature

    Time frame: Up to 4 years

    Time to the first occurrence of composite endpoint of CV death, MI, stroke, ALI [any unanticipated revascularization or amputation of ischemic limb]), and urgent hospitalization for vascular cause of ischemic nature (including deep vein thrombosis [DVT] and pulmonary embolism [PE]) will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Acronym: LIBREXIA-AF

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.