Dual Antithrombotic Therapy with Dabigatran and Ticagrelor in Patients with Acute Coronary Syndrome and Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (ADONIS-PCI)
This study, called ADONIS-PCI, is looking for a better balance between preventing blood clots and limiting major bleeding in people with two heart conditions: acute coronary syndrome (like a heart attack) and an irregular heartbeat called non-valvular atrial fibrillation. These patients have already had a procedure to open up blocked heart arteries. Researchers are testing different doses of a blood-thinning medicine to see which one works best. The main thing they're watching closely is if the treatment causes any significant bleeding. They will also look at how well it prevents further heart problems like heart attacks or strokes. This is a Phase III trial, meaning it's a key step to see if this treatment is a good option.
At a glance
What is this study about?
This study, called ADONIS-PCI, is for people who have recently experienced a serious heart problem, like a heart attack, and also have a common type of irregular heartbeat called atrial fibrillation. These individuals have recently undergone a procedure to unblock their heart arteries, often called a PCI or 'stent' procedure. After such events and procedures, it's very important to prevent blood clots from forming, as these can lead to further heart attacks or strokes.
However, the medicines used to prevent clots, often called 'blood thinners,' can also increase the risk of bleeding. This study is trying to find the best way to protect patients from harmful clots while keeping the risk of serious bleeding as low as possible. Researchers are testing different doses of a specific blood-thinning medicine to see which one achieves this balance most effectively.
The main goal of the study is to see if one dose of the medicine causes less serious bleeding than another. They will also be carefully monitoring other important heart issues like heart attacks, strokes, or the need for more heart procedures. By understanding these effects better, doctors hope to offer safer and more effective treatment plans for patients with these complex heart conditions.
Key takeaways
- This study is for people who have had a heart attack and an irregular heartbeat.
- It's testing different doses of a blood-thinning medicine to find the best balance.
- The main focus is on reducing serious bleeding while preventing clots.
- It aims to improve treatment for patients after heart procedures.
- Participation contributes to medical knowledge for future patients.
Who may be eligible?
To join this study, participants need to be at least 18 years old. Both men and women are welcome to take part. The study is specifically for people who have recently had a serious heart event, such as a heart attack, which is medically known as 'acute coronary syndrome.'
Participants also need to have a specific type of irregular heartbeat called 'non-valvular atrial fibrillation.' This means your heart's upper chambers beat irregularly, and it's not caused by a problem with your heart valves.
Crucially, you must have also recently undergone a procedure to open up blocked heart arteries, often called a PCI. There will also be other medical criteria that the study doctors will review to ensure the study is safe and appropriate for you.
- Are you 18 years old or older?
- Have you recently had a heart attack or similar heart problem?
- Do you have a diagnosis of non-valvular atrial fibrillation (an irregular heartbeat not caused by valve problems)?
- Have you recently had a heart procedure to open up blocked arteries (PCI)?
- Are you able to attend regular follow-up appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you will be given specific dosages of a study medicine called Brilique (also known as ticagrelor), which comes as tablets. You will be carefully monitored throughout the study. This will likely involve regular hospital visits, where doctors and nurses will perform health checks, blood tests, and ask about any symptoms or side effects you might be experiencing.
These visits help the study team understand how the medicine is affecting you and if it's working as intended. The exact number and frequency of visits, as well as the total length of time you'll be involved in the study, will be fully explained by the study team. You'll receive detailed information about your medication schedule and any follow-up appointments required.
Potential risks and benefits
Locations (1)
- —Poland
Common questions
What is 'acute coronary syndrome'?
It's a medical term for a serious heart problem like a heart attack, where blood flow to the heart muscle is suddenly blocked.
What does 'non-valvular atrial fibrillation' mean?
It's a type of irregular heartbeat that isn't caused by issues with your heart valves. It can increase your risk of stroke.
What is 'PCI'?
PCI stands for Percutaneous Coronary Intervention. It's a procedure to open narrowed or blocked heart arteries, often using a balloon and a small tube called a stent.
What is the main thing the study is looking for?
The study is mainly trying to see which dose of the blood-thinning medicine causes the least amount of serious bleeding, while still preventing clots.
What are 'Brilique 60 mg' and 'Brilique 90 mg'?
These are different doses of a blood-thinning medicine called ticagrelor, which is being tested in this study.
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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