A Randomized Study of Andexanet Alfa Compared to Usual Care in Patients Receiving a Factor Xa Inhibitor who Require Urgent Surgery or Procedure (ANNEXA-RS)
This research, called ANNEXA-RS, is a study for people who are currently taking certain blood-thinning medications, such as apixaban, rivaroxaban, or edoxaban. If these patients need urgent surgery or a medical procedure, they might be at higher risk of bleeding. The study is comparing a new treatment, Andexanet Alfa (also known as Ondexxya), with the standard care usually given in these situations. The main goal is to find out if Andexanet Alfa is better at controlling bleeding during the operation. This is a Phase III trial, which means it's a key step to see if the new medicine works well and is safe before it can be widely used. The study will look at how well bleeding is stopped during surgery and also check how the blood thinners are affecting the body.
At a glance
What is this study about?
Imagine you're taking a special type of medicine called a 'blood thinner' (like apixaban, rivaroxaban, or edoxaban). These medicines are really important for preventing blood clots, but they also mean you might bleed more easily. Now, what if you suddenly need an urgent operation or a medical procedure? Doctors need a way to quickly reverse the effects of these blood thinners so that bleeding can be controlled during your surgery.
This study, called ANNEXA-RS, is looking at a new medicine named Andexanet Alfa. It's designed to help reverse the blood-thinning effect quickly. The researchers are comparing it to the usual care doctors give in these urgent situations. The main question they want to answer is: Does Andexanet Alfa help stop bleeding more effectively during urgent surgery or procedures in people taking these specific blood thinners?
This research is really important because it could lead to better ways to manage bleeding risks for patients who need urgent surgery while on blood thinners. It’s about making urgent operations safer and improving patient care.
Key takeaways
- This study compares a new medicine for reversing blood thinners during urgent surgery.
- It's for people taking apixaban, rivaroxaban, or edoxaban who need urgent operations.
- The main goal is to see if bleeding is better controlled during surgery.
- Participants will receive either the new medicine or standard care.
- The study helps improve safety for patients needing urgent surgery while on blood thinners.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part. A key requirement is that you are currently taking one of these specific blood-thinning medications: apixaban, rivaroxaban, or edoxaban.
Another important point is that you must be needing urgent surgery or a medical procedure. The doctors involved in the study will also need to decide that you have a high risk of bleeding during this procedure if your blood thinner's effect isn't reversed.
There might be other medical conditions or medications that would prevent you from taking part, but the study doctor will go through all of these details with you to make sure it's safe and appropriate 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?
- Are you currently taking apixaban, rivaroxaban, or edoxaban?
- Do you need urgent surgery or a medical procedure soon?
- Has your doctor said you have a high risk of bleeding during this procedure?
- Are you able to provide consent (agreement) to take part?
What does participation involve?
If you decide to take part in this study, you would receive either the new medicine, Andexanet Alfa, or the standard care that would normally be given. Which treatment you receive is decided randomly, like flipping a coin. During your urgent surgery or procedure, the study doctors will carefully monitor how well any bleeding is controlled.
After your procedure, they will also take blood samples at specific times, including before and up to two hours after your surgery starts, to measure how the blood thinners are affecting your body. The total length of your participation will depend on your medical situation and recovery from surgery, but the core part of the study involves monitoring during and shortly after your procedure.
Potential risks and benefits
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Common questions
What is a 'blood thinner' and why is it important?
Blood thinners are medicines that help prevent harmful blood clots from forming in your body. They are important for conditions like irregular heartbeat or having had a past blood clot.
What does 'urgent surgery' mean in this study?
It means an operation or procedure that can't be safely delayed, often necessary due to a sudden or worsening health problem.
What is Andexanet Alfa (Ondexxya)?
This is a new medication being tested. It's designed to quickly reverse the effects of certain blood thinners, aiming to help control bleeding during urgent procedures.
Will I know if I'm getting the new medicine or standard care?
No, usually in studies like this, it's 'blinded,' meaning neither you nor the doctors treating you would know. This helps ensure fair results.
Will participating in this study affect my usual hospital care?
No, your usual medical care for your surgery and recovery will continue as normal. The study adds specific monitoring and either the new drug or standard treatment.
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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