RecruitingOBSERVATIONAL

An Investigator-initiated Linked Study to OCEANIC-AF

This study investigates how two blood-thinning medicines, asundexian and apixaban, affect the body's natural ability to dissolve blood clots. Some people have a higher risk of heart attack or stroke because their blood struggles to break down clots. While other medications thin the blood, they don't always improve this natural clot-dissolving process. This research hopes to find out if asundexian can boost this natural ability more effectively than apixaban. The findings could lead to more targeted treatments for patients who, despite taking standard blood thinners, still have a higher risk due to poor natural clot breakdown.

At a glance

Status

Recruiting

Sponsor

East and North Hertfordshire NHS Trust

Enrolment target

100

Start

03 Nov 2023

Estimated completion

17 Sep 2026

Atrial Fibrillation

What is this study about?

Imagine your body has its own clean-up crew that dissolves blood clots when they're no longer needed. This process is called 'fibrinolysis.' When this clean-up crew isn't working as well as it should, people might be at a higher risk of serious problems like heart attacks or strokes, even if they're taking other blood-thinning medications.

Researchers are looking for new medicines that can make this natural clot-dissolving process more efficient. This study focuses on a new type of blood thinner called asundexian. We want to see if asundexian can help your body's clean-up crew work better than an existing, widely used blood thinner called apixaban.

To do this, we'll be asking people who are already taking part in another important study called OCEANIC-AF if they'd be willing to provide a few extra blood samples. The OCEANIC-AF study is already comparing asundexian and apixaban, so this is a really good opportunity to get more information without asking participants to do too much extra. The results of this study could help doctors understand how to better protect people who are at risk of blood clots.

Key takeaways

Investigates if a new blood thinner, asundexian, improves natural clot dissolving.
Compares asundexian's effect to an existing blood thinner, apixaban.
Aims to find targeted treatments for high-risk patients with poor natural clot breakdown.
Uses extra blood samples from participants already in the OCEANIC-AF study.
No changes to your current medication or additional clinic visits are required for this study.
Participation helps advance understanding of blood clot prevention.

Who may be eligible?

To be part of this study, you must be 18 years or older and already taking part in the main OCEANIC-AF study. It's important that you are willing and able to understand the study information and give your consent in writing.

You wouldn't be able to join if you have certain existing health conditions that might make it difficult to get clear results from the study. These include serious problems with your brain, liver, kidneys, hormones, digestion, lungs, or if you have any conditions that make you bleed easily. Also, if you have a history of substance abuse, an active substance abuse issue, or certain mental health conditions, you wouldn't be suitable.

They also check for specific blood test results that are outside normal ranges, or if you drink more than 21 units of alcohol per week. Basically, the study needs participants who are generally healthy enough to ensure the results accurately reflect the effect of the medications on clot-dissolving abilities.

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?
Are you already participating in the main OCEANIC-AF study?
Are you able to provide written consent and understand the study information?
Do you have any serious existing health conditions (e.g., severe kidney, liver, or brain problems, or conditions that cause easy bleeding)?
Do you have a history of substance abuse or active substance abuse, or serious psychiatric conditions?
Do you drink more than 21 units of alcohol per week?

Answer every question to see your result.

What does participation involve?

If you choose to take part, your participation will mainly involve providing additional blood samples. These samples will be taken when you already have appointments for the main OCEANIC-AF study, so you won't need extra visits. The researchers will analyze these samples to measure how well your blood dissolves clots when you are taking either asundexian or apixaban. You will continue to take your study medication (either asundexian or apixaban) as prescribed within the OCEANIC-AF study. There are no additional medications or changes to your existing treatment specifically for this linked study. The duration of your participation will align with your involvement in the main OCEANIC-AF study, for which this is a linked project.

Potential risks and benefits

The main benefit of taking part is that you would be contributing to important medical research that could improve future treatments for people at risk of blood clots. There are no direct medical benefits to you personally from this study, but your existing medical care through the OCEANIC-AF project will continue. The main risk involves the discomfort and very small chance of bruising or infection from the extra blood samples taken. You are free to withdraw from this linked study at any time without affecting your participation in the main OCEANIC-AF study or your medical care.

Locations (2)

Liverpool Heart and Chest Hospital
Verified postcode
Liverpool, United Kingdom· Not yet recruiting
East and North Herts NHS Trust
Verified postcode
Stevenage, United Kingdom· Recruiting

Common questions

What is 'fibrinolysis'?

Fibrinolysis is your body's natural process of breaking down and dissolving blood clots after they have formed. It's like your body's internal clean-up crew for clots.

Why is this study important?

This study is important because it could help us find new ways to improve the body's natural clot-dissolving ability, which might reduce the risk of heart attacks and strokes for some people.

Will I have to take different medication for this study?

No, you will continue to take the medication (either asundexian or apixaban) that you are already receiving as part of the main OCEANIC-AF study. This study only involves extra blood tests.

What are the main risks of taking part?

The main risks are typically minimal and relate to the blood tests, such as slight discomfort, bruising, or a very small chance of infection at the site where blood is taken.

Will I get paid for taking part?

The study information shared does not mention any payment for participation. It's best to discuss this directly with the study team if you're considering joining.

How to find out more

Joshua H Leader, MBCHB, BSc

joshua.leader@nhs.net 07376188768 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.