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

Recruiting in Palo Alto (17 mi)

+1373 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Janssen Research & Development, LLC

Must be taking: Anticoagulants

Disqualifiers: Valve disease, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on anticoagulation for a condition other than atrial fibrillation, you may not be eligible to participate.

What data supports the effectiveness of the drug Apixaban for atrial fibrillation?

Apixaban is an oral drug that helps prevent blood clots and has been shown to be effective in preventing venous thromboembolism (VTE) after knee or hip replacement surgery. It is also being developed for preventing strokes in patients with atrial fibrillation, which suggests its potential effectiveness for this condition.¹ ² ³ ⁴ ⁵

Is Apixaban safe for humans?

Apixaban, also known as Eliquis, has been shown to be generally safe for humans, with a lower risk of major bleeding compared to warfarin in patients with atrial fibrillation. It is used to prevent blood clots and has been approved for various conditions, including after hip or knee replacement surgery.¹ ⁵ ⁶ ⁷ ⁸

What makes the drugs Milvexian and Apixaban unique for treating atrial fibrillation?

Milvexian and Apixaban are both anticoagulants (blood thinners) used to prevent blood clots in atrial fibrillation. Milvexian is a newer drug that may offer different dosing or side effect profiles compared to Apixaban, which is already well-established in this role.⁹ ¹⁰ ¹¹ ¹² ¹³

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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.

Inclusion Criteria

I am 75 or older, or have had a stroke, or I am 65-74 with two of the following: high blood pressure, diabetes, heart disease, or heart failure.

I have atrial fibrillation and can take blood thinners.

I am at least 18 years old.

See 1 more

Exclusion Criteria

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

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either milvexian or apixaban orally, twice daily, from Day 1 through the end of treatment

Up to 4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into receiving open-label apixaban for 30 days after the end of treatment

Treatment Details

Interventions

Apixaban (Factor Xa Inhibitor)
Milvexian (Factor Xa Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

Sparrow Clinical Research InstituteLansing, MI

Our Lady of the Lake Physicians Group LLCBaton Rouge, LA

Sun Research InstituteSan Antonio, TX

Centre intégré universitaire de santé et de services sociaux de Trois-RivièresTrois-Rivières, Canada

More Trial Locations

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Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1022

Patients Recruited

6,408,000+

Bristol-Myers Squibb

Industry Sponsor

Trials

2731

Patients Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apixaban: first global approval.Watson, J., Whiteside, G., Perry, C.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apixaban: a review of its use in the prevention of venous thromboembolism after knee or hip replacement surgery.Deeks, ED.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive evaluation of apixaban in the treatment of venous thromboembolism.Koehl, JL., Hayes, BD., Al-Samkari, H., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apixaban: A Review in Venous Thromboembolism.Greig, SL., Garnock-Jones, KP.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LC-MS/MS determination of apixaban (BMS-562247) and its major metabolite in human plasma: an application of polarity switching and monolithic HPLC column.Pursley, J., Shen, JX., Schuster, A., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe.Mayall, S., Kahlon, R., Al-Dakkak, I., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-Analysis of Effectiveness and Safety of Oral Anticoagulants in Atrial Fibrillation With Focus on Apixaban.Bai, Y., Shi, XB., Ma, CS., et al.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Treatment with Apixaban in Patients with Atrial Fibrillation: Outcomes during the Open-Label Extension following AVERROES.Benz, AP., Eikelboom, JW., Yusuf, S., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Transition From Ambrisentan to Macitentan in Patients With Pulmonary Arterial Hypertension: A Real-word Prospective Study.Chen, Y., Luo, J., Chen, J., et al.[2022]

In a study involving 14 healthy male subjects, macitentan did not alter the pharmacokinetics or pharmacodynamics of warfarin, indicating that the two medications can be safely used together without requiring dose adjustments.

The study found that plasma concentrations of warfarin remained consistent whether macitentan was administered or not, suggesting no significant drug interactions between these two treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of the effect of macitentan on the pharmacokinetics and pharmacodynamics of warfarin in healthy male subjects.Sidharta, PN., Dietrich, H., Dingemanse, J.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transition from Ambrisentan to Bosentan in Pulmonary Arterial Hypertension: A Single-Center Prospective Study.Gong, SG., Wang, L., Pudasaini, B., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of dabigatran etexilate as periprocedural anticoagulation therapy for atrial fibrillation ablation.Yamaji, H., Murakami, T., Hina, K., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and hemodynamic benefit of macitentan and riociguat upfront combination in patients with pulmonary arterial hypertension.Sulica, R., Sangli, S., Chakravarti, A., et al.[2020]

References

1.New Zealandpubmed.ncbi.nlm.nih.gov

Apixaban: first global approval. [2021]

2.New Zealandpubmed.ncbi.nlm.nih.gov

Apixaban: a review of its use in the prevention of venous thromboembolism after knee or hip replacement surgery. [2021]

3.Englandpubmed.ncbi.nlm.nih.gov

A comprehensive evaluation of apixaban in the treatment of venous thromboembolism. [2021]

4.New Zealandpubmed.ncbi.nlm.nih.gov

Apixaban: A Review in Venous Thromboembolism. [2020]

5.Englandpubmed.ncbi.nlm.nih.gov

LC-MS/MS determination of apixaban (BMS-562247) and its major metabolite in human plasma: an application of polarity switching and monolithic HPLC column. [2022]

6.New Zealandpubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe. [2021]

7.United Statespubmed.ncbi.nlm.nih.gov

Meta-Analysis of Effectiveness and Safety of Oral Anticoagulants in Atrial Fibrillation With Focus on Apixaban. [2017]

8.Germanypubmed.ncbi.nlm.nih.gov

Long-Term Treatment with Apixaban in Patients with Atrial Fibrillation: Outcomes during the Open-Label Extension following AVERROES. [2021]

9.Switzerlandpubmed.ncbi.nlm.nih.gov

The Transition From Ambrisentan to Macitentan in Patients With Pulmonary Arterial Hypertension: A Real-word Prospective Study. [2022]

10.New Zealandpubmed.ncbi.nlm.nih.gov

Investigation of the effect of macitentan on the pharmacokinetics and pharmacodynamics of warfarin in healthy male subjects. [2021]

11.Egyptpubmed.ncbi.nlm.nih.gov

Transition from Ambrisentan to Bosentan in Pulmonary Arterial Hypertension: A Single-Center Prospective Study. [2019]