What side effects are associated with this type of intervention?

Common treatments for ischemic stroke include antiplatelet agents, anticoagulants, and thrombolytics. Antiplatelet agents like aspirin can cause gastrointestinal bleeding and ulcers. Anticoagulants such as warfarin and newer agents like rivaroxaban may lead to bleeding complications, including intracranial hemorrhage. Thrombolytics like alteplase can also cause significant bleeding, including in the brain. For treatments similar to Milvexian, a Factor XIa inhibitor, the primary concern is bleeding, although specific side effect profiles for Factor XIa inhibitors are still being studied.

What prior FDA approvals exist?

The FDA has approved several treatments for ischemic stroke, primarily focusing on thrombolytic and antithrombotic therapies. Tissue plasminogen activator (tPA) is a well-known thrombolytic agent approved for acute ischemic stroke to dissolve clots. Antithrombotic agents like aspirin and clopidogrel are commonly used to prevent recurrent strokes by inhibiting platelet aggregation. While Factor XIa inhibitors like Milvexian are still under investigation, they represent a novel approach targeting the coagulation cascade to reduce the risk of recurrent ischemic events. Other anticoagulants, such as warfarin and direct oral anticoagulants (DOACs) like rivaroxaban, have also been used for stroke prevention in patients with atrial fibrillation.

What other types of research exist?

Promising novel alternatives to Milvexian for ischemic stroke patients include Concizumab and Marstacimab. Both are monoclonal antibodies targeting tissue factor pathway inhibitor (TFPI) and have shown significant efficacy in reducing bleeding rates in hemophilia patients, which suggests potential benefits in managing thrombotic conditions like ischemic stroke. Additionally, direct oral anticoagulants (DOACs) such as Apixaban, Rivaroxaban, and Dabigatran, which have been effective in preventing venous thromboembolism, may also be considered as alternatives.

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Milvexian for Stroke (LIBREXIA-STROK 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

Be older than 18 years old

Must not have

Current active liver disease, eg, acute hepatitis, known cirrhosis, including participants receiving antiviral treatment for hepatitis

Increased risk of bleeding, including clinically significant bleeding within the previous 3 months or known bleeding diathesis or known activated partial thromboplastin time (aPTT) prolongation or spinal cord hemorrhage or retinal hemorrhage

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to global targeted endpoint date (approximately 41 months)

Awards & highlights

Pivotal Trial

Summary

This trial is testing whether milvexian can help prevent another stroke in people who have already had one by stopping blood clots from forming. Milvexian may reduce the risk of stroke without significant bleeding.

Who is the study for?

This trial is for adults who've recently had a mild ischemic stroke or high-risk TIA, with specific criteria like NIHSS score <=7 and an ABCD2 Score >=6. They must be able to take low-dose antiplatelet medication and not be at risk of pregnancy. Exclusions include prior serious brain bleeds, strokes from heart problems needing blood thinners, other non-athero-thrombotic causes, bleeding risks, liver disease, or allergies to the study drug.

What is being tested?

The LIBREXIA-STROKE trial is testing if Milvexian can prevent another stroke better than a placebo (a dummy pill). Participants are chosen randomly to receive either Milvexian or placebo within 48 hours after their initial stroke or TIA symptoms start.

What are the potential side effects?

While the side effects of Milvexian aren't detailed here, common concerns in similar medications may include increased risk of bleeding, potential allergic reactions, and possibly liver issues given the exclusion criteria related to liver health.

Eligibility Criteria

Exclusion Criteria

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

Select...

I have an active liver disease such as hepatitis or cirrhosis.

Select...

I have a high risk of bleeding or had significant bleeding in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to global targeted endpoint date (approximately 41 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to global targeted endpoint date (approximately 41 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to global targeted endpoint date (approximately 41 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 Ischemic Stroke

Secondary study objectives

Time to First Occurrence of any Component of Major Adverse Vascular Events (MAVE)

Time to First Occurrence of any Component of the Composite of Cardiovascular Death (CVD), Myocardial Infraction (MI), or Ischemic Stroke

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 after an acute ischemic stroke or high-risk transient ischemic attack (TIA) who are receiving antiplatelet therapy standard-of-care (SAPT \[single antiplatelet therapy\] or DAPT \[dual antiplatelet therapy\]) will receive milvexian 25 milligrams (mg), orally, twice daily.

Group II: PlaceboPlacebo Group1 Intervention

Participants after an acute ischemic stroke or high-risk TIA who are receiving antiplatelet therapy standard-of-care (SAPT or DAPT) 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 / 2Eligibility 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 ischemic stroke primarily involve antithrombotic therapies, which include anticoagulants and antiplatelet agents. These treatments work by preventing the formation of new blood clots and the growth of existing clots, thereby improving blood flow to the brain. Milvexian, a Factor XIa inhibitor, specifically targets Factor XIa in the coagulation cascade, reducing thrombin generation and clot formation without significantly increasing the risk of bleeding. This is crucial for ischemic stroke patients as it helps to minimize the risk of recurrent strokes while maintaining a safer profile compared to traditional anticoagulants.