Milvexian for Stroke

(LIBREXIA-STROK Trial)

Recruiting at 966 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must be taking: Antiplatelets

Disqualifiers: Intracranial hemorrhage, Cardio-embolic stroke, Bleeding risk, Active liver disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 90 days

15000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that current or planned antiplatelet treatment is allowed. If you are taking acetyl salicylic acid (ASA), it should be limited to a low dose of 75 to 100 mg per day.

What makes the drug Milvexian unique for stroke treatment?

Milvexian is unique because it is an oral anticoagulant that targets Factor XIa, a specific protein involved in blood clot formation, which may offer a new approach to preventing strokes compared to traditional anticoagulants that target other pathways. ^{1 2 3 4 5}

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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.

Inclusion Criteria

I had a stroke or TIA with specific conditions met.

Willing and able to adhere to the lifestyle restrictions specified in this protocol

I am not pregnant, breastfeeding, nor planning to become pregnant soon after the study ends.

Exclusion Criteria

My stroke or TIA was caused by a reason other than blood clot issues.

I had a brain bleed over a year ago and received proper treatment for it.

My stroke or TIA was caused by a clot from the heart, and I need blood thinners.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive milvexian or placebo orally twice daily after an acute ischemic stroke or high-risk transient ischemic attack

90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

41 months

Treatment Details

Interventions

• Milvexian
• Placebo

Trial Overview 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.

Participant Groups

Group I: Milvexian Experimental Treatment 1 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

Bristol Myers Squibb Company (BMS)

Collaborator

Trials

2

Recruited

15,000+

Findings from Research

Mexidol shows promise in post-stroke rehabilitation due to its broad effects on various disorders, particularly when used in long-term therapy to improve motor, cognitive, and emotional functions.

A tailored approach to rehabilitation, incorporating Mexidol and other treatments, is recommended to enhance patient outcomes, but further high-quality clinical studies are needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacotherapy in post-stroke rehabilitation]. Lyukmanov, RK., Rimkevichus, AA., Gnedovskaya, EV., et al.[2022]

Dalfampridine extended release (D-ER) was generally well tolerated in 83 participants with chronic post-ischemic stroke deficits, with no new safety concerns identified compared to previous trials.

The study found that D-ER significantly improved walking speed compared to placebo, indicating potential benefits for lower extremity sensorimotor function in stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dalfampridine in chronic sensorimotor deficits after ischemic stroke: A proof of concept study. Simpson, DM., Goldenberg, J., Kasner, S., et al.[2022]

In a multicenter, randomized, placebo-controlled study involving 252 acute ischemic stroke patients, edaravone showed a significant improvement in functional outcomes compared to placebo, as measured by the modified Rankin Scale (p = 0.0382).

Edaravone acts as a neuroprotective agent by inhibiting vascular endothelial cell injury and reducing neuronal damage, suggesting its potential as an effective treatment for acute ischemic stroke when administered within 72 hours of onset.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a novel free radical scavenger, edaravone (MCI-186), on acute brain infarction. Randomized, placebo-controlled, double-blind study at multicenters. [2022]

The combination of atomoxetine and intensive speech therapy was safe and feasible for four adult patients with post-stroke aphasia, with no adverse effects reported during the study.

All patients showed improvements in language function, with significant increases in scores on language assessments and enhanced cortical blood flow in areas surrounding the brain lesions, indicating potential therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atomoxetine administration combined with intensive speech therapy for post-stroke aphasia: evaluation by a novel SPECT method. Yamada, N., Kakuda, W., Yamamoto, K., et al.[2019]

Dengzhanhua injection demonstrated a significantly higher total effective rate (92.0%) compared to fufangdanshen injection (75.8%) in treating acute cerebral infarction among 100 patients, indicating its superior efficacy.

The treatment with dengzhanhua injection also led to significant improvements in hemorrheology and lipemia without any adverse reactions, suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical curative effect of dengzhanhua injection on acute cerebral infarction: a report of 100 cases]. Zhang, SF., He, MD., Li, C.[2006]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Pharmacotherapy in post-stroke rehabilitation]. [2022]

2. Sweden pubmed.ncbi.nlm.nih.gov

Dalfampridine in chronic sensorimotor deficits after ischemic stroke: A proof of concept study. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of a novel free radical scavenger, edaravone (MCI-186), on acute brain infarction. Randomized, placebo-controlled, double-blind study at multicenters. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Atomoxetine administration combined with intensive speech therapy for post-stroke aphasia: evaluation by a novel SPECT method. [2019]

5. China pubmed.ncbi.nlm.nih.gov

[Clinical curative effect of dengzhanhua injection on acute cerebral infarction: a report of 100 cases]. [2006]