Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events following Left Atrial Appendage Closure – Chronic Kidney Disease (SAFE LAAC CKD). Comparative Health Effectiveness Ancillary Study – PILOT
This study, called SAFE LAAC CKD, is looking at how well two common antiplatelet medicines, aspirin and clopidogrel, work after a procedure to close off a small pouch in the heart. This procedure is called Left Atrial Appendage Closure (LAAC) and is often done for people with an irregular heartbeat (atrial fibrillation) to reduce stroke risk. The study focuses specifically on patients who also have ongoing kidney problems (chronic kidney disease). The main goal is to find out which medicine best prevents serious problems like stroke or heart attack, and also which one causes the fewest serious bleeding issues. It's a 'Phase IV' study, meaning it's looking at medicines already approved for use, but in a new way or for a specific group of patients.
At a glance
What is this study about?
This study, named SAFE LAAC CKD, is an important research project looking into the best way to care for people who have two medical conditions: an irregular heartbeat, known as atrial fibrillation, and ongoing kidney problems, called chronic kidney disease.
People with atrial fibrillation are often at a higher risk of having a stroke. To reduce this risk, some choose to have a procedure called Left Atrial Appendage Closure (LAAC). This procedure involves sealing off a small pouch in the heart where blood clots can form. After this procedure, patients usually take medicines to help prevent blood clots.
This research aims to compare two common medicines: aspirin and clopidogrel. Both of these medicines help to thin the blood and prevent clots. The study wants to discover which of these two medicines is better at preventing serious problems like strokes, heart attacks, or other major heart-related events. At the same time, it's very important to see which medicine causes fewer serious bleeding problems, as all blood-thinning medicines carry a risk of bleeding. By finding the best balance, doctors can make more informed decisions about ongoing care for these patients.
Key takeaways
- Compares two common medicines (aspirin, clopidogrel) after a heart procedure.
- Focuses on people with irregular heartbeat (atrial fibrillation) and kidney disease.
- Aims to prevent strokes and reduce bleeding risks.
- Involves regular check-ups and monitoring.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you would need to be an adult, aged 18 years or older – there is no upper age limit. The study is open to both men and women.
Beyond age and sex, the study is specifically for people who have had a procedure called Left Atrial Appendage Closure (LAAC) because they have an irregular heartbeat (atrial fibrillation). You would also need to have chronic kidney disease, which means your kidneys aren't working as well as they should.
There might be other health conditions or medicines that could mean you can't take part, so doctors will carefully check if this study is right for you.
- Are you 18 years old or older?
- Have you had a Left Atrial Appendage Closure (LAAC) procedure?
- Do you have an irregular heartbeat (atrial fibrillation)?
- Do you have ongoing kidney problems (chronic kidney disease)?
- Are you willing to take either aspirin or clopidogrel as part of the study?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would be assigned to take either aspirin or clopidogrel, depending on what the research team decides is best for the study. You would need to take your assigned medication regularly as instructed.
Throughout the study, you would have regular check-ups, which might include blood tests and sometimes scans like brain MRIs. These visits will help doctors monitor your health, check for any side effects, and see how well the medicine is working. One of the goals is to look at brain scans for very small changes and also to check thinking and memory skills. The study will also review your health and medicine use one month after your LAAC procedure and continue keeping track of your health over time. The exact number of visits and their timing would be explained in detail by the study team, but generally, participation involves ongoing follow-up to monitor your health and the effects of the treatment.
Potential risks and benefits
Locations (1)
- —Poland
Common questions
What is 'atrial fibrillation'?
Atrial fibrillation is a common type of irregular heartbeat that can increase your risk of stroke.
What is 'Left Atrial Appendage Closure (LAAC)?
It's a procedure where a small pouch in the heart, where blood clots can form, is sealed off to reduce stroke risk.
What are aspirin and clopidogrel?
These are common medicines that help prevent blood clots. They are sometimes called 'blood thinners'.
What does 'chronic kidney disease' mean?
This means your kidneys aren't working as well as they should be, for a long time.
Will I know which medicine I'm taking?
The study team will explain how the medicines are given and whether you will know which one you are receiving.
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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