What is the mechanism of action of this treatment?

Common treatments for Atrial Fibrillation (AF) include anticoagulants, rate control, and rhythm control medications. Anticoagulants, such as Factor Xa inhibitors (e.g., apixaban) and the investigational Factor XIa inhibitor milvexian, work by inhibiting specific factors in the coagulation cascade to prevent clot formation, thereby reducing the risk of stroke and systemic embolism. Rate control medications, like beta blockers and calcium channel blockers, slow the heart rate by affecting the atrioventricular (AV) node, while rhythm control medications, such as antiarrhythmic drugs, aim to restore and maintain normal heart rhythm. These treatments are essential for AF patients as they help manage symptoms, prevent complications, and improve overall quality of life.

What side effects are associated with this type of intervention?

Common treatments for atrial fibrillation, such as Factor Xa inhibitors (e.g., Apixaban) and Factor XIa inhibitors (e.g., Milvexian), primarily aim to reduce the risk of stroke and systemic embolism. Known side effects of these anticoagulants include an increased risk of bleeding, which can range from minor bleeding (such as bruising or nosebleeds) to major bleeding events (such as gastrointestinal bleeding or intracranial hemorrhage). Other potential side effects may include gastrointestinal symptoms like nausea and dyspepsia. It is important for patients to discuss these risks with their healthcare provider to ensure appropriate management and monitoring.

What prior FDA approvals exist?

The FDA has approved several direct oral anticoagulants (DOACs) for the treatment of Atrial Fibrillation, which include drugs like apixaban, rivaroxaban, edoxaban, and dabigatran. These medications work by inhibiting specific factors in the coagulation pathway to reduce the risk of stroke and systemic embolism in patients with AF. Apixaban, for instance, is a Factor Xa inhibitor, similar in function to the Factor XIa inhibitor Milvexian being studied. These DOACs have been shown to be effective alternatives to traditional vitamin K antagonists like warfarin.

What other types of research exist?

Promising novel alternatives to Milvexian for Atrial Fibrillation patients include Apixaban, Rivaroxaban, and Edoxaban, which are direct Factor Xa inhibitors. Additionally, other investigational drugs such as Concizumab, a monoclonal antibody against TFPI, and Marstacimab, another monoclonal antibody against TFPI, are also being explored for their efficacy and safety in reducing thromboembolic events.

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Factor Xa Inhibitor

Milvexian vs Apixaban for Atrial Fibrillation (LIBREXIA-AF Trial)

Phase 3

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Atrial fibrillation eligible to receive anticoagulation

Minimum age of 18 years

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called milvexian to see if it can prevent strokes and blood clots as well as an existing drug, apixaban. Apixaban (Eliquis™) was developed by Bristol-Myers Squibb and Pfizer and has been approved for the prevention of stroke in patients with certain heart conditions. The study focuses on patients who are at risk of these serious conditions. Milvexian works by helping to keep the blood flowing smoothly, reducing the chances of dangerous clots forming.

Who is the study for?

This trial is for adults with atrial fibrillation who need long-term anticoagulation. It's suitable for those over 18, especially if they're 65 or older with additional risk factors like high blood pressure, diabetes, heart disease, or a history of stroke.

What is being tested?

The study compares Milvexian and Apixaban to see which one is better at preventing strokes and systemic embolism in people with atrial fibrillation. Participants will receive either the test drug Milvexian or the standard treatment Apixaban.

What are the potential side effects?

Potential side effects may include bleeding complications since both Milvexian and Apixaban are blood thinners designed to prevent clotting. The exact side effects of Milvexian are being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have atrial fibrillation and can take blood thinners.

Select...

I am at least 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have serious heart valve problems that might need surgery during the study.

Select...

I need long-term blood thinners for a condition other than atrial fibrillation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Time to CV Death

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

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

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MilvexianExperimental Treatment2 Interventions

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: ApixabanActive Control2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Milvexian

2020

Completed Phase 1

~210

Placebo

1995

Completed Phase 3

~2670

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Atrial Fibrillation (AF) include anticoagulants, rate control, and rhythm control medications. Anticoagulants, such as Factor Xa inhibitors (e.g., apixaban) and the investigational Factor XIa inhibitor milvexian, work by inhibiting specific factors in the coagulation cascade to prevent clot formation, thereby reducing the risk of stroke and systemic embolism. Rate control medications, like beta blockers and calcium channel blockers, slow the heart rate by affecting the atrioventricular (AV) node, while rhythm control medications, such as antiarrhythmic drugs, aim to restore and maintain normal heart rhythm. These treatments are essential for AF patients as they help manage symptoms, prevent complications, and improve overall quality of life.