(20604 OCEANIC STROKE) A multicenter, randomized, placebo controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA
This research study, called OCEANIC STROKE, is testing a new oral medicine called asundexian. Its main goal is to see if this medicine can help prevent another stroke in adults (18 years and older) who have recently experienced a certain type of stroke or a high-risk mini-stroke (TIA). Participants will be randomly given either the new medicine or a dummy pill (placebo) without knowing which one they receive. The study will carefully monitor if the new medicine is effective at preventing strokes and will also check for any side effects, especially bleeding. This is a large study to confirm if asundexian is a safe and effective treatment to protect people from future strokes.
At a glance
What is this study about?
Imagine you've recently had a stroke or a 'mini-stroke' (doctors call this a TIA, or Transient Ischemic Attack). When this happens, there's a risk you might have another one. Doctors are always looking for new and better ways to lower this risk and keep you healthy.
This study is looking into a new medicine called asundexian. It's a tablet you take by mouth. We want to find out if this medicine can help stop people from having another stroke. The study is called OCEANIC STROKE, and it's a 'Phase 3' study, which means it's one of the final steps before a new medicine might be approved for general use. It's a big study involving many people to make sure the results are clear.
The main things we'll be watching for are whether people taking asundexian have fewer strokes compared to those taking a dummy pill (placebo). We'll also be carefully checking for any side effects, especially bleeding, which can sometimes be a concern with medicines that affect blood clotting. By doing this research, we hope to find a new way to protect people, like you, from the serious impact of future strokes.
Key takeaways
- New medicine (asundexian) aims to prevent future strokes.
- For adults who recently had a stroke or high-risk mini-stroke.
- Compares medicine to a dummy pill (placebo).
- Focuses on how well it prevents strokes and checks for bleeding.
- Your choice to participate, you can leave anytime.
- Doctor will check if it's right for you.
Who may be eligible?
This study is looking for adult volunteers, aged 18 years or older. Both men and women can take part.
You might be able to join if you've recently had a certain type of stroke, which doctors call an ischemic stroke that wasn't caused by a heart problem. You could also be eligible if you've recently had a high-risk mini-stroke, known as a TIA.
Other specific medical details and recent treatments will also be checked by the study team to make sure it's safe for you to participate and that the study results are accurate. Your doctor will help determine if this study is suitable for you.
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 18 years old or older?
- Have you recently had an ischemic stroke (not from a heart problem)?
- Or, have you recently had a high-risk mini-stroke (TIA)?
- Are you able to take a daily oral medicine?
- Are you willing to attend regular clinic visits?
What does participation involve?
If you decide to join, you'll be randomly assigned to either receive the new medicine (asundexian) or a dummy pill (placebo), much like drawing lots. Neither you nor your study doctor will know which one you are taking. This helps us get fair and unbiased results.
You would need to take the study medicine daily. You'll have regular visits to the clinic for health checks, blood tests, and to discuss how you're feeling and if you've had any health events. These visits will help the study team monitor your health and the effects of the medicine.
Further details about the exact number of visits, tests, and the total length of time you'd be in the study would be fully explained by the study team. It's important to understand this commitment before you decide to take part.
Potential risks and benefits
Locations (20)
- —UnverifiedSlovakia
- —UnverifiedLatvia
- —UnverifiedHungary
- —UnverifiedSweden
- —UnverifiedNetherlands
- —UnverifiedAustria
- —UnverifiedFinland
- —UnverifiedGermany
- —UnverifiedCzechia
- —UnverifiedNorway
- —UnverifiedBelgium
- —UnverifiedSpain
Common questions
What is an 'ischemic stroke'?
An ischemic stroke happens when blood flow to part of the brain is blocked, often by a blood clot. This study focuses on strokes not caused by heart problems.
What is a 'TIA'?
A TIA, or Transient Ischemic Attack, is like a mini-stroke. It has similar symptoms to a stroke but the symptoms are temporary. It's a warning sign that you might be at risk of a full stroke.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the real medicine but contains no active drug. It helps researchers compare the new medicine's effects against doing nothing extra.
Why don't I know if I'm getting the real medicine or the placebo?
This is called a 'double-blind' study. It's important so that neither you nor the doctors treating you are influenced in how they feel or report symptoms, making the study results more reliable.
Can I stop taking part in the study if I change my mind?
Yes, absolutely. Your participation is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your standard medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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