Active not recruitingPHASE3INTERVENTIONAL

A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE

This study is called LIBREXIA-STROKE and it's looking into a new medicine, milvexian, for people who have recently experienced an ischemic stroke or a high-risk mini-stroke (Transient Ischemic Attack, or TIA). The main goal is to find out if milvexian can lower the chance of having another ischemic stroke compared to a placebo (a dummy pill). Volunteers will be randomly given either milvexian or the placebo. This is a Phase 3 study, which means it's a large study to confirm the medicine's safety and effectiveness. If you've recently had a stroke or TIA and are aged 40 or over, you might be able to take part.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

12,532

Start

15 Feb 2023

Estimated completion

09 Dec 2026

Ischemic Stroke; Ischemic Attack, Transient

What is this study about?

If you've recently had a stroke or a 'mini-stroke' (doctors call this a Transient Ischemic Attack or TIA), you might be wondering about ways to prevent another one. This study, called LIBREXIA-STROKE, is looking at a new medicine called milvexian to see if it can help. We want to find out if giving milvexian to people who have recently had an ischemic stroke or a high-risk TIA can reduce their chances of having another stroke.

An ischemic stroke happens when a blood clot blocks a blood vessel in the brain. A TIA is similar but the blockage is temporary, causing stroke-like symptoms that usually clear up quickly. Both are serious and mean you're at higher risk of another stroke. This study compares milvexian against a placebo, which looks just like the study medicine but doesn't contain any active drug. This helps us know for sure if any changes are due to milvexian or something else.

By taking part, you would be helping researchers understand if milvexian could be a new and effective way to protect people from future strokes. This kind of research is really important for improving future treatments and preventing serious health problems.

Key takeaways

The study aims to see if milvexian can prevent future strokes in people who've recently had one.
It's for people aged 40 or over who have had an ischemic stroke or a high-risk TIA.
Participants will receive either milvexian or a placebo, not knowing which one.
You'll have regular medical check-ups and continue with some of your usual medications.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be part of this study, you generally need to be at least 40 years old and have recently had either an ischemic stroke or a high-risk TIA. For a stroke, it needs to have been a mild one, and doctors will have seen signs of it on scans, or you received standard treatments like clot-busting medicines or a procedure to remove the clot. If it was a TIA, your symptoms must have completely resolved, and doctors would have assessed it as high-risk.

You would also need to be able to start the study within 48 hours of your stroke or TIA symptoms starting. It's also important that you are already receiving or planning to receive standard antiplatelet medication (like low-dose aspirin). If you are a woman of childbearing age, you must agree not to be pregnant, breastfeeding, or planning to become pregnant during the study and for a short period after your last dose of the study medicine.

There are some reasons why you might not be able to join. For instance, if you've had certain types of bleeding in the brain before, or if your stroke or TIA is thought to be due to certain heart problems that would require different medication, or if there's another clear reason for your stroke not related to blood vessel blockages.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 40 years old or older?
Have you recently had a mild ischemic stroke or a high-risk mini-stroke (TIA)?
Are you able to start the study within 48 hours of your stroke/TIA symptoms starting?
Are you already taking or planning to take antiplatelet medication (like low-dose aspirin)?
If you are a woman who could become pregnant, are you willing to avoid pregnancy during the study and for a short time after?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to either receive milvexian or a placebo (a dummy pill, which doesn't contain active medicine). You won't know which one you're getting, and neither will your study doctor. You'll take the study medication regularly as instructed. You'll also likely continue with your usual antiplatelet medication, such as low-dose aspirin.

The study will involve a number of visits to the clinic, where you'll have check-ups, blood tests, and possibly other assessments. These appointments are to monitor your health, see how you're responding to the medication, and check for any side effects. The exact number and frequency of visits will be explained by the study staff. You will continue to take the study medication and attend follow-up appointments for a period of time, which the study team will explain in detail.

Potential risks and benefits

Taking part in a clinical study can have potential benefits, such as receiving close medical attention and access to a new potential treatment that isn't widely available yet. However, there are also potential risks. Milvexian is designed to affect blood clotting, so there might be a risk of bleeding, although the study will closely monitor for this. There could also be other side effects, some of which we may not know about yet, as this is a new medicine. You'll be carefully monitored throughout the study for any health changes or side effects. Remember, taking part is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (880)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Banner Desert Medical Center
Verified postcode
Mesa, United States
University of Arizona
Verified postcode
Tucson, United States
Plaza Neuroscience Clinic
Verified postcode
Fayetteville, United States
Alta Bates Medical Center Cancer Center
Verified postcode
Berkeley, United States
Providence Saint Joseph Medical Center - Cancer Center
Verified postcode
Burbank, United States
Mills Peninsula Health Services
Verified postcode
Burlingame, United States
Sutter Health - Eden Medical Center
Verified postcode
Castro Valley, United States
Neurology Center of North Orange County
Verified postcode
Fullerton, United States
Glendale Adventist Medical Center
Verified postcode
Glendale, United States
UC Irvine Healthcare Center
Verified postcode
Irvine, United States
Sharp Grossmont Hospital
Verified postcode
La Mesa, United States
Long Beach Memorial
Verified postcode
Long Beach, United States

Common questions

What is an ischemic stroke?

An ischemic stroke happens when a blood clot blocks a blood vessel in the brain, stopping blood flow and causing damage to brain cells.

What is a TIA (mini-stroke)?

A TIA, or Transient Ischemic Attack, is like a mini-stroke. It's caused by a temporary blockage of blood flow to the brain, leading to stroke-like symptoms that usually clear up quickly without lasting damage.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'blinded' study. Neither you nor your study doctor will know whether you are receiving milvexian or the placebo. This helps ensure unbiased results.

Can I continue taking my other medications?

Yes, you will continue with your current antiplatelet treatment (like low-dose aspirin) as advised by your doctor. The study team will review all your medications.

What if I experience side effects?

The study team will monitor you closely for any side effects. It's very important to tell them about any new or worsening symptoms you experience immediately.