A Phase 3 prospective randomised clinical trial of VMX-C001 vs usual pharmacological care in patients receiving a FXa direct oral anticoagulant (FXa DOAC) who require urgent surgery or other invasive procedure that is associated with a high risk of bleeding, with or without planned administration of heparin (EQUILIBRIX-S)
This study, called EQUILIBRIX-S, is for adults who take a specific type of blood thinner called a Factor Xa inhibitor (FXa DOAC) and urgently need an operation or other medical procedure where there's a high chance of bleeding. Doctors usually prescribe blood thinners to prevent blood clots. However, when urgent surgery is needed, these medicines can make bleeding more likely. This study aims to find out if a new medicine, VMX-C001, is better than the standard care at controlling bleeding during these procedures. Researchers want to see how well VMX-C001 works compared to current treatments to ensure bleeding is managed effectively and safely when it matters most.
At a glance
What is this study about?
Imagine you're taking a medicine to keep your blood from clotting too much, maybe after a deep vein thrombosis or to prevent a stroke. These medicines, called Factor Xa inhibitors (or FXa DOACs), are really good at what they do. But what if you suddenly need an emergency operation or a procedure that could cause a lot of bleeding? In those situations, your doctors need a way to quickly stop the blood-thinning effect so they can perform the procedure safely.
This study is looking at a new medicine called VMX-C001. It's designed to help control bleeding during urgent operations or procedures for people who are taking these specific blood thinners. Researchers want to compare VMX-C001 to the usual treatments doctors currently use. They want to see if VMX-C001 can help manage bleeding better and more effectively, making these urgent procedures safer for patients.
The main goal is to find out if VMX-C001 helps doctors achieve 'good' or 'excellent' control of any bleeding during the procedure. An independent group of experts will review the results, without knowing who received VMX-C001 and who received the usual care, to make sure the findings are fair and accurate. This is a "Phase 3" study, which means it's one of the final steps to confirm if this new medicine is safe and works well enough to be widely used.
Key takeaways
- This study compares a new medicine (VMX-C001) for controlling bleeding.
- It's for people on specific blood thinners (FXa DOACs) needing urgent surgery.
- The goal is to see if VMX-C001 works better than current treatments.
- Participation involves being randomly assigned to a treatment group.
- You have the right to leave the study at any time.
Who may be eligible?
This study is looking for adult patients, meaning anyone 18 years old or over. There's no upper age limit, so people of all adult ages can be considered. Both men and women are welcome to take part.
To be eligible, you must currently be taking a specific type of blood thinner called a Factor Xa inhibitor (FXa DOAC). Also, you need to be in a situation where you urgently require surgery or another medical procedure that doctors believe carries a high risk of bleeding.
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 currently taking a Factor Xa inhibitor (FXa DOAC) blood thinner?
- Do you need urgent surgery or a medical procedure?
- Has your doctor told you this procedure has a high risk of bleeding?
What does participation involve?
If you decide to take part in this study, you would be assigned by chance (like flipping a coin) to either receive the new medicine VMX-C001 or to receive the standard treatment that doctors would normally give. You wouldn't get to choose which one you receive.
Throughout your procedure, doctors will carefully monitor your bleeding and how well it is controlled. There will also be follow-up checks to make sure you are recovering well and to look for any side effects. The exact number of visits and tests will depend on your specific procedure and recovery, but the study team will explain everything in detail if you are interested.
Potential risks and benefits
Locations (15)
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedCzechia
- —UnverifiedBulgaria
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedNetherlands
- —UnverifiedPoland
- —UnverifiedAustria
- —UnverifiedEstonia
Common questions
What is a FXa DOAC?
FXa DOACs are medicines that thin your blood to prevent clots. Common examples include rivaroxaban (Xarelto) or apixaban (Eliquis).
Why is this study important?
It's important because it aims to find better ways to manage bleeding quickly and safely for people on blood thinners who need urgent surgery.
Will I know if I'm getting the new medicine or regular care?
No, this is a 'blinded' study. Neither you nor your doctors will know which treatment you are receiving, to keep the results fair.
Who is paying for this study?
The study is likely funded by the company developing VMX-C001, but the decision to participate is always yours.
What if I have questions during the study?
The study team will provide you with contact details for any questions or concerns you might have.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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