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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

LIBREXIA-AF Trial Summary

This trial tests if a new drug, milvexian, is as good as apixaban at preventing stroke and blood clots outside the brain.

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.Check my eligibility
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.See study design
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.

LIBREXIA-AF Trial 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.

LIBREXIA-AF Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to the First Occurrence of Composite Endpoint of Stroke and Non-central nervous system (CNS) Systemic Embolism
Secondary outcome measures
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

LIBREXIA-AF 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
Placebo
1995
Completed Phase 3
~2670
Milvexian
2020
Completed Phase 1
~210

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,368,808 Total Patients Enrolled
32 Trials studying Atrial Fibrillation
1,285,759 Patients Enrolled for Atrial Fibrillation
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,113,500 Total Patients Enrolled
72 Trials studying Atrial Fibrillation
1,631,868 Patients Enrolled for Atrial Fibrillation
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,944,405 Total Patients Enrolled

Media Library

Apixaban (Factor Xa Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05757869 — Phase 3
Atrial Fibrillation Research Study Groups: Apixaban, Milvexian
Atrial Fibrillation Clinical Trial 2023: Apixaban Highlights & Side Effects. Trial Name: NCT05757869 — Phase 3
Apixaban (Factor Xa Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05757869 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Milvexian been sanctioned by the Federal Drug Administration?

"Our team at Power has assessed the safety of Milvexian as a 3 due to pre-existing evidence for its efficacy, and multiple studies conducted which have supported its security."

Answered by AI

How many medical facilities are currently carrying out this clinical trial?

"The aforementioned medical trial is administered through Ascension St. Vincent's Health System in Birmingham, Arizona, SEC Clinical Research in Dothan, California and HH Heart Center and Heart Center in Huntsville, Colorado; with additional sites across 1156 other cities."

Answered by AI

Are there any opportunities for enrolment in this experiment?

"Regrettably, this clinical trial is not currently accepting any candidates. Initially posted on April 13th 2023 and last updated February 24th 2023, the study is inactive for now. However, there are 475 alternative trials actively enrolling participants presently."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
Southwest Cardiovascular Associates
Jamaica Hospital Medical Center
The Lindner Clinical Trial Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I believe I meet the qualifications. My brother who got stroke in 2029. He has memory loss.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation
2023. "A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05757869.
All > Afib > Spokane
~10333 spots leftby Mar 2027
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