Ischemic Stroke > Milvexian

Milvexian for Stroke

(LIBREXIA-STROK Trial)

Recruiting in Palo Alto (17 mi)

+969 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: Antiplatelets

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

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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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.

Trial 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

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Phelps Memorial Hospital Center Sleepy Hollow, NY

Chattanooga Center for Neurologic Research Chattanooga, TN

Texas Tech El Paso, TX

Spectrum Health System Grand Rapids, MI

More Trial Locations

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC Lead Sponsor

Bristol Myers Squibb Company (BMS) Collaborator

References

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

[Pharmacotherapy in post-stroke rehabilitation]. [2022] The article presents data on the conditions of use and efficacy of botulinum toxin preparations, oral muscle relaxants, selective serotonin reuptake inhibitors, acetylcholinesterase inhibitors and a glutamatergic transmission modulator in post-stroke neurorehabilitation, and provides recommendations for their rational and safe use. The clinical efficacy of Mexidol, which has a polymodal effect on a wide range of post-stroke disorders, especially in long-term sequential therapy, is discussed. A complex use of post-stroke rehabilitation methods with the determination of individual tactics based on the clinical picture of the patient and the defined rehabilitation goals is recommended. The inclusion of Mexidol in the complex therapy of patients with stroke consequences for tasks related to improving motor, affective and cognitive functions and self-care and quality of life looks promising. It is necessary to continue high-quality clinical studies to assess the pharmaceuticals efficacy in relation to post-stroke disorders.

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

Dalfampridine in chronic sensorimotor deficits after ischemic stroke: A proof of concept study. [2022] To evaluate the safety and tolerability of dalfampridine extended release (D-ER) in participants with chronic post-ischemic stroke deficits, and to assess for potential drug activity on sensorimotor function.

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] Edaravone, a novel free radical scavenger, demonstrates neuroprotective effects by inhibiting vascular endothelial cell injury and ameliorating neuronal damage in ischemic brain models. The present study was undertaken to verify its therapeutic efficacy following acute ischemic stroke. We performed a multicenter, randomized, placebo-controlled, double-blind study on acute ischemic stroke patients commencing within 72 h of onset. Edaravone was infused at a dose of 30 mg, twice a day, for 14 days. At discharge within 3 months or at 3 months after onset, the functional outcome was evaluated using the modified Rankin Scale. Two hundred and fifty-two patients were initially enrolled. Of these, 125 were allocated to the edaravone group and 125 to the placebo group for analysis. Two patients were excluded because of subarachnoid hemorrhage and disseminated intravascular coagulation. A significant improvement in functional outcome was observed in the edaravone group as evaluated by the modified Rankin Scale (p = 0.0382). Edaravone represents a neuroprotective agent which is potentially useful for treating acute ischemic stroke, since it can exert significant effects on functional outcome as compared with placebo.

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] We clarified the safety, feasibility, and efficacy of atomoxetine administration combined with intensive speech therapy (ST) for patients with post-stroke aphasia. In addition, we investigated the effect of atomoxetine treatment on neural activity of surrounding lesioned brain areas.

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

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