What side effects are associated with this type of intervention?

Common treatments for Acute Coronary Syndrome (ACS) include antiplatelet agents like aspirin and clopidogrel, anticoagulants such as warfarin and direct oral anticoagulants (DOACs) like rivaroxaban, and newer agents like Factor XIa inhibitors (e.g., Milvexian). The primary side effect of these treatments is an increased risk of bleeding, which can range from minor bruising to severe hemorrhage. Other side effects may include gastrointestinal issues (e.g., ulcers with aspirin), hypersensitivity reactions, and, in the case of some anticoagulants, potential liver enzyme elevations. Factor XIa inhibitors are being studied for their potential to reduce bleeding risks compared to traditional anticoagulants.

What prior FDA approvals exist?

The FDA has approved several treatments for Acute Coronary Syndrome (ACS), primarily focusing on antiplatelet and anticoagulant therapies. Commonly used antiplatelet agents include aspirin and P2Y12 inhibitors like clopidogrel, prasugrel, and ticagrelor. Anticoagulants such as heparin, low molecular weight heparins (e.g., enoxaparin), and direct oral anticoagulants (DOACs) like rivaroxaban and apixaban are also approved. While specific Factor XIa inhibitors like Milvexian are still under investigation, these existing treatments aim to reduce the risk of major adverse cardiovascular events by preventing clot formation and improving blood flow.

What other types of research exist?

Promising, novel alternatives to Milvexian for Acute Coronary Syndrome patients include direct oral anticoagulants (DOACs) such as dabigatran, rivaroxaban, and apixaban. These agents have been studied extensively and have shown efficacy in reducing the risk of major adverse cardiovascular events.

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Milvexian for Acute Coronary Syndrome (LIBREXIA-ACS 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

Participants must have an index event that meets all 3 of the following criteria within 7 days prior to randomization: a) clinical syndrome consistent with spontaneous cardiac ischemia, b) diagnosis of acute coronary syndrome (ACS) (that is, ST-elevation myocardial infarction [STEMI], non-STEMI, or unstable angina [UA]), c) cardiac biomarker elevation (example, troponin I, troponin T, creatine kinase-MB [CK-MB]) above the upper limit of normal as determined by the local laboratory

Be older than 18 years old

Must not have

Conditions with a significant increased risk of bleeding (example, clinically significant bleeding within previous 3 months, known bleeding diathesis, et cetera)

Planned CABG or staged PCI after randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years 6 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called milvexian to see if it can better prevent serious heart problems like heart attacks and strokes in patients who are at high risk. The medication works by preventing blood clots, which helps keep blood flowing smoothly.

Who is the study for?

This trial is for adults who recently had a heart-related emergency (acute coronary syndrome) with certain risk factors like being over 65, diabetes, or past heart issues. They must not need chronic blood thinners and should have no major bleeding risks or planned heart surgeries after joining the study.

What is being tested?

The study tests if Milvexian can better prevent serious heart problems when added to usual treatments compared to a placebo. It focuses on avoiding events like death from heart causes, new heart attacks, and strokes in patients who've just had one such event.

What are the potential side effects?

While specific side effects of Milvexian aren't listed here, similar medications often cause increased bleeding risk. Participants will be monitored for any adverse reactions throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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I had symptoms of a heart attack and confirmed heart damage within the last week.

Exclusion Criteria

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

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I haven't had significant bleeding or a bleeding disorder in the last 3 months.

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I am scheduled for heart bypass surgery or a procedure to open my heart's arteries.

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My heart attack was caused by a lack of oxygen to the heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years 6 months 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 First Occurrence of Major Adverse Cardiovascular Event (MACE)

Secondary study objectives

Time to All-cause Mortality (ACM)

Time to Cardiovascular (CV) Death

Time to the First Occurrence of Composite of All-cause Mortality (ACM), Myocardial Infarction (MI) and Ischemic Stroke

+1 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

Placebo Group

Group I: MilvexianExperimental Treatment1 Intervention

Participants enrolled within 7 days of an acute coronary syndrome (ACS), who have undergone cardiac catheterization with percutaneous intervention (PCI) or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (single antiplatelet therapy \[SAPT\] or dual antiplatelet therapy \[DAPT\]) as determined by the investigator will receive milvexian 25 milligrams (mg), orally, twice daily.

Group II: PlaceboPlacebo Group1 Intervention

Participants enrolled within 7 days of an ACS, who have undergone cardiac catheterization with PCI or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (SAPT or DAPT) as determined by the investigator will receive placebo orally, twice daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Milvexian

2020

Completed Phase 1

~210

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 Acute Coronary Syndrome (ACS) often include antithrombotic agents such as aspirin, clopidogrel, and newer agents like Factor XIa inhibitors (e.g., Milvexian). These medications work by inhibiting various pathways in the blood clotting process. Aspirin inhibits platelet aggregation by blocking the enzyme cyclooxygenase, while clopidogrel prevents platelets from clumping together by inhibiting the P2Y12 receptor. Factor XIa inhibitors, like Milvexian, target and inhibit Factor XIa, a key enzyme in the coagulation cascade that leads to thrombus (clot) formation. By preventing clot formation, these treatments reduce the risk of major adverse cardiovascular events (MACE) such as myocardial infarction (heart attack), ischemic stroke, and cardiovascular death, which are critical concerns for ACS patients.