A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation
This important study is looking into a new medicine called milvexian for people who have an irregular heartbeat, known as atrial fibrillation. Currently, a medicine called apixaban is often used to prevent problems like strokes in these patients. We want to find out if milvexian works just as well as, or even better than, apixaban in reducing the risk of strokes and other serious blood clot-related issues. The study will involve giving some people milvexian and others apixaban, and some might also get a dummy treatment to help us compare properly. Taking part could help improve treatments for atrial fibrillation in the future, offering more options to keep people safe from complications like stroke.
At a glance
What is this study about?
If you have atrial fibrillation, it means your heart beats with an irregular rhythm, which can sometimes lead to blood clots forming. These clots can then travel to your brain and cause a stroke, or to other parts of your body. Doctors often prescribe medicines called 'anticoagulants' or 'blood thinners' to help prevent these dangerous clots from forming.
This study is comparing a newer medicine, called milvexian, with a medicine that's already commonly used, called apixaban. Both are designed to prevent blood clots. We want to see if milvexian is at least as effective as apixaban in stopping serious events like strokes and other blood clot-related problems in people with atrial fibrillation. Finding new, effective treatments is important because it gives more choices and potentially better ways to protect people from these serious health risks.
By taking part, you would be helping doctors and researchers understand if milvexian could be a safe and effective new option for preventing strokes in people with atrial fibrillation. This kind of research is vital for improving how we care for this common heart condition, potentially leading to better health outcomes for many in the future.
Key takeaways
- Compares milvexian vs. apixaban for stroke prevention in atrial fibrillation.
- Aims to see if milvexian is at least as effective as current treatments.
- Involves regular clinic visits and health checks.
- Participation could help improve future treatments for atrial fibrillation.
- You won't know if you're on the new drug, standard drug, or a dummy pill.
Who may be eligible?
To join this study, you need to be at least 18 years old and have atrial fibrillation, a condition where your heart beats irregularly. You should also be generally healthy enough to take blood-thinning medication long-term.
We are particularly looking for people with atrial fibrillation who have certain risk factors. This includes if you are 75 or older, or if you've had a stroke before. Alternatively, you might qualify if you are aged 65 to 74 and have two or more of these risk factors: high blood pressure, diabetes, blood vessel disease (atherosclerosis), or heart failure.
However, you wouldn't be able to join if you have certain severe heart valve problems that might need surgery soon, or if you need to take blood thinners for another medical condition that isn't atrial fibrillation.
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 at least 18 years old?
- Do you have atrial fibrillation?
- Are you generally healthy enough for blood-thinning medicine?
- Are you 75 or older, or have you had a stroke before?
- If aged 65-74, do you have high blood pressure, diabetes, blood vessel disease, or heart failure (two or more of these)?
What does participation involve?
If you decide to join this study, you would first have some checks to make sure it's right for you. If you qualify, you'd be given either milvexian, apixaban, or a dummy pill (placebo) to take. There's also a chance you might receive a dummy version of apixaban for comparison. You wouldn't know which one you're taking, nor would the doctors, as this helps make sure the results are fair. You'd need to visit the clinic regularly for check-ups, blood tests, and to discuss how you're feeling. These visits will help us monitor your health and how the medicine is working. The study would last for a period of time, and all your medical care related to the study would be carefully overseen by a team of doctors and nurses.
Potential risks and benefits
Locations (1052)
- Advanced Cardiovascular, LLCVerified postcodeAlexander City, United States
- Ascension St. Vincent's Health SystemVerified postcodeBirmingham, United States
- SEC Clinical ResearchVerified postcodeDothan, United States
- HH Heart Center and Heart CenterVerified postcodeHuntsville, United States
- CB Flock Research CorporationVerified postcodeMobile, United States
- Mercy Gilbert Medical CenterVerified postcodeGilbert, United States
- Valleywise Health Medical CenterVerified postcodePhoenix, United States
- Arizona Arrhythmia Research CenterVerified postcodePhoenix, United States
- Arizona Heart HospitalVerified postcodePhoenix, United States
- HonorHealth Neurology 1Verified postcodeScottsdale, United States
- HonorHealth NeurologyVerified postcodeScottsdale, United States
- Arkansas Heart HospitalVerified postcodeLittle Rock, United States
Common questions
What is atrial fibrillation?
It's an irregular and often very rapid heart rhythm that can increase your risk of strokes.
Why is this study important?
It helps us find out if a new medicine (milvexian) is as good as existing ones (apixaban) at preventing strokes in people with atrial fibrillation.
Will I know which medicine I'm taking?
No, both you and your study doctor won't know if you're taking milvexian, apixaban, or a dummy pill (placebo). This helps ensure fair results.
What are the main risks of taking part?
The main risks are potential side effects from the medication, such as an increased risk of bleeding, which will be monitored closely.
Can I leave the study if I change my mind?
Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your normal 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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