RE-DUAL TICLO PCI: Dual Therapy with dabigatran/ticagrelor versus Dual Therapy with dabigatran/clopidogrel in ACS patients with indication for NOAC undergoing PCI.
This study, called RE-DUAL TICLO PCI, focuses on people who have recently had a heart attack (acute coronary syndrome) and are having a procedure called PCI to open up blocked heart arteries. After this, they need to take medicines to prevent blood clots. The study compares two different combinations of medicines: one includes dabigatran and ticagrelor, and the other includes dabigatran and clopidogrel. Both combinations aim to prevent serious blood clots, but doctors also want to find the safest option that causes the fewest bleeding side effects. Researchers will follow participants for 12 months, checking for any bleeding events, as well as looking at how well the treatments prevent new heart attacks, strokes, or other harmful blood clots. The goal is to improve care for people with these heart conditions.
At a glance
What is this study about?
This research study is for people who have recently experienced a type of heart problem called acute coronary syndrome, often known as a heart attack. After a heart attack, it's common for doctors to need to perform a procedure called PCI (Percutaneous Coronary Intervention). This procedure involves placing a small tube (stent) into a blocked heart artery to help blood flow better.
Following a PCI, it's very important to take medicines to prevent new blood clots from forming in the arteries, which could lead to another heart attack or a stroke. The study is comparing two different combinations of these medicines. Both combinations include dabigatran, which is a blood-thinning medicine. The difference is the second medicine: one group will take ticagrelor, and the other will take clopidogrel. Both ticagrelor and clopidogrel also help prevent blood clots.
The main goal of the study is to see which of these two medicine combinations causes less bleeding, as bleeding can be a serious side effect of blood-thinning drugs. Researchers will also be looking at how well each combination prevents harmful blood clots, like those that cause heart attacks or strokes. By comparing these two common treatment approaches, doctors hope to find the best and safest way to help people recover after a heart attack and PCI.
Key takeaways
- Targets adults who have had a heart attack and a PCI procedure.
- Compares two medicine combinations to prevent blood clots.
- Main goal: find which combination causes less bleeding.
- Also checks how well treatments prevent new heart attacks or strokes.
- Participation involves taking specific medicines and regular check-ups for 12 months.
- Helps improve future care for heart patients.
Who may be eligible?
This study is looking for adults who are at least 18 years old. Both men and women can take part.
You would be considered for this study if you have recently had a type of heart attack called acute coronary syndrome. You also need to be scheduled to have a special procedure called PCI, which helps open up blocked heart arteries.
Crucially, you must also have a clear reason why your doctor has decided you need to take a specific type of blood-thinning medicine called a 'NOAC' (Novel Oral Anticoagulant), such as dabigatran, as part of your treatment plan.
- Are you 18 years old or older?
- Have you recently had a heart attack (acute coronary syndrome)?
- Are you scheduled to have a heart procedure called PCI?
- Has your doctor decided you need to take a NOAC medicine (like dabigatran)?
- Are you able to commit to 12 months of follow-up visits?
- Are you happy to take one of the two study medicine combinations?
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 will be given one of two medicine combinations to take. The study will involve regular check-ups and assessments over a period of 12 months. These will likely include visits to the hospital or clinic, where doctors and nurses will monitor your health, ask how you are feeling, and check for any side effects, especially bleeding. You will also be monitored to see how well the treatment prevents blood clots. The total duration of active follow-up for the main goals of the study is 12 months.
Potential risks and benefits
Locations (1)
- —Netherlands
Common questions
What is 'acute coronary syndrome'?
It's a serious heart condition that includes heart attacks, where the blood supply to part of your heart is suddenly blocked.
What is 'PCI'?
PCI stands for Percutaneous Coronary Intervention. It's a procedure where doctors use a small balloon or tube to open up blocked heart arteries and often place a small mesh tube called a stent to keep it open.
What does 'bleeding event' mean?
It refers to any bleeding that might happen as a side effect of blood-thinning medicines. The study is looking at both major bleeding and other bleeding that is still considered important by doctors.
What is the study testing?
It's comparing two different combinations of blood-thinning medicines to see which one causes less bleeding while still preventing serious blood clots like heart attacks or strokes.
How long will I be followed in the study?
Researchers will follow your health and progress for 12 months after you start the 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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