Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

(19767 OCEANIC-AF) A multicenter, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oral FXIa inhibitor asundexian (BAY 2433334) with apixaban for the prevention of stroke or systemic embolism in male and female participants aged 18 years and older with atrial fibrillation at risk for stroke

This important study, named OCEANIC-AF, is comparing a new medication called asundexian (also known as BAY 2433334) with an existing treatment called apixaban (Eliquis). Both drugs are used to help prevent strokes and serious blood clots in adults who have atrial fibrillation, a common heart rhythm problem. Researchers want to find out if asundexian is as good as, or better than, apixaban at stopping these problems, and if it's safe to use. This is a large study involving many different centres and patients, and participants won't know which treatment they are receiving, nor will their doctors, to ensure fair results. The main focus is on reducing the risk of stroke and avoiding significant bleeding.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Bayer AG

Enrolment target

9,578

Start

08 Sep 2023

Prevention of stroke or systemic embolism in atrial fibrillation

What is this study about?

You might be reading this because you or someone you know has atrial fibrillation, a condition where your heart beats irregularly. People with atrial fibrillation have a higher risk of developing blood clots that can travel to the brain and cause a stroke, or to other parts of the body causing a serious clot. To help prevent this, doctors often prescribe medications known as 'blood thinners' or anticoagulants.

This study, called OCEANIC-AF, is looking at a new potential medication named asundexian. It's being compared to a medication that's already widely used and known to be effective, called apixaban (you might know it by its brand name, Eliquis). The main goal is to see if asundexian is just as good, or even better, than apixaban at preventing strokes and other serious blood clots. The researchers are also carefully looking at how safe asundexian is, especially concerning its potential to cause bleeding, which can be a side effect of all blood-thinning medications.

When you participate in a study like this, neither you nor your doctor will know whether you are receiving the new medicine (asundexian) or the existing one (apixaban). This helps make sure the results are fair and unbiased. The study is also looking at several other important factors, such as different types of strokes, heart attacks, and any serious bleeding events, to get a full picture of how the new drug performs.

Key takeaways

Compares a new drug (asundexian) with an existing one (apixaban) for stroke prevention.
For adults with atrial fibrillation who are at risk of stroke.
Aims to see if the new drug is effective and safe, especially regarding bleeding.
Participants don't know which treatment they are receiving (double-blind).
Involves regular clinic visits and close monitoring.
You can stop participating at any time.

Who may be eligible?

This study is open to both men and women aged 18 years and older who have atrial fibrillation. You would need to be at risk for a stroke to be considered for participation, which is common for people with atrial fibrillation.

To ensure the study is safe and the results are clear, there will be certain health conditions or medications that might mean you can't join. For example, if you have certain severe kidney or liver problems, or if you're already taking specific types of medications that might interfere with the study drugs, you might not be eligible. You would also need to be able to safely take the study medications and attend all the planned appointments.

It's important to discuss your full medical history and all your current medications with the study team to see if this trial is right for you. They will check all the details to make sure it's safe for you to take part.

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?
Do you have atrial fibrillation?
Are you able to take daily medication regularly?
Are you willing and able to attend all planned hospital appointments for check-ups?
Do you understand that you might receive the new drug or an existing treatment?
Do you feel comfortable discussing your full medical history with the study team?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the new drug (asundexian) or the standard treatment (apixaban). You might also be given a 'placebo' for the other drug, which looks identical but contains no active medicine, just to keep everyone 'blinded' to which main treatment you are getting. You would take your assigned medication regularly as instructed.

Throughout the study, you'll have regular visits to the clinic. These visits will involve health checks, blood tests, and discussions about how you're feeling and any side effects you might be experiencing. The study team will monitor your health very closely. This could be over a period of several years. The overall commitment would involve taking daily medication and attending these regular follow-up appointments, which could be in person or sometimes by phone.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as contributing to medical knowledge that could help future patients with atrial fibrillation. You will also receive careful medical monitoring throughout the study. However, there are potential risks, as with any medication. Blood thinners, including those in this study, can increase the risk of bleeding, which can range from minor bruises to more serious bleeding. There's also a chance you might experience side effects from either the new drug or the existing one. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (22)

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

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Unverified
Finland
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Unverified
Norway
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Unverified
Denmark
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Unverified
Hungary
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Unverified
Spain
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Unverified
Estonia
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Unverified
Sweden
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Unverified
Czechia
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Unverified
Austria
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Unverified
Lithuania
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Unverified
Belgium
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Unverified
Romania

Common questions

What is atrial fibrillation?

Atrial fibrillation is a condition where the heart's upper chambers (atria) beat irregularly and sometimes very quickly, which can increase the risk of stroke.

What does 'double-blind' mean?

It means that neither you, the participant, nor your doctors or the research team will know whether you are receiving the new drug or the standard treatment. This helps make the study results fair.

What is a 'placebo'?

A placebo is a tablet or liquid that looks exactly like the real medication but doesn't contain any active drug. It's used in studies to ensure fair comparison without knowing which drug is being taken.

Why is this study important for stroke prevention?

Finding new, safe, and effective ways to prevent strokes in people with atrial fibrillation is crucial to improve their long-term health and quality of life.

Can I continue my other medications if I join?

You will need to discuss all your current medications with the study team. Some medications might not be allowed during the study to ensure your safety and the accuracy of the results.