All studies
AuthorisedTherapeutic use (Phase IV)Interventional

COATS (genetic Clopidogrel response testing to finetune the antithrombotic regimen in (D)OAC Treated patients undergoing PCI) Study

The COATS study is investigating the best way to use blood-thinning medicines like Ticagrelor (Brilique) and Clopidogrel for patients who have heart artery disease and are having a procedure called PCI (Percutaneous Coronary Intervention). This procedure helps open up narrowed heart arteries. Researchers want to see if using a genetic test to help decide which blood thinner to give leads to better outcomes. They are checking both how safe these treatments are (looking at serious bleeding) and how well they work to prevent serious heart problems like heart attacks, strokes, or even death, over 12 months. The study also compares these outcomes against what's usually expected from similar treatments, and explores how different patient groups respond to the medicines.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Enrolment target
520
Start
13 Sep 2024

What is this study about?

This study, called COATS, is for people who have coronary heart disease. This is when the blood vessels that supply your heart become narrowed or blocked, which can lead to problems like angina or heart attacks. If you have this condition, you might need a procedure called a PCI (Percutaneous Coronary Intervention). This is a common treatment where a small balloon is used to open up the narrowed artery, and often a small mesh tube called a stent is put in to keep it open.

After a PCI, most patients need to take blood-thinning medicines to prevent blood clots from forming in the stent or elsewhere. This study is looking at two specific blood thinners: Ticagrelor (which you might know as Brilique) and Clopidogrel. The main idea is to see if a special genetic test could help doctors choose the best blood thinner for you, potentially making the treatment safer and more effective. Researchers will compare how well these drugs work and if they cause any major side effects, especially bleeding, over a year.

The study aims to understand if a personalised approach, using genetic information, can improve patient care. They want to ensure that patients are getting the most appropriate medicine to prevent serious heart problems like another heart attack, a stroke, or a dangerous blood clot in the stent, while also making sure the risk of serious bleeding is kept as low as possible. They will also look at how patients feel about their quality of life during the study.

Key takeaways

  • This study looks at common blood thinners, Ticagrelor (Brilique) and Clopidogrel.
  • It's for people with heart artery disease who are having a PCI procedure.
  • Researchers are seeing if a genetic test can help choose the best blood thinner for you.
  • The study watches for serious bleeding and heart problems over one year.
  • It aims to make treatments after PCI safer and more effective.

Who may be eligible?

To be considered for this study, you would need to be an adult, at least 18 years old. The study is open to both men and women.

The main condition for joining is that you have coronary artery disease and your doctors have decided that you need a procedure called Percutaneous Coronary Intervention (PCI). This means your heart's blood vessels are narrowed or blocked, and you're having an intervention to open them up.

There might be other specific health requirements or conditions that would mean you can't join the study, but these would be discussed in detail by the study team. They need to make sure the study is suitable and safe 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.

  1. Are you 18 years old or older?
  2. Do you have coronary artery disease?
  3. Are you scheduled to have a PCI (Percutaneous Coronary Intervention) procedure?
  4. Are you willing to take either Ticagrelor (Brilique) or Clopidogrel as prescribed?
  5. Can you commit to 12 months of follow-up?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be prescribed either Ticagrelor or Clopidogrel, which are common medications after a PCI procedure. The study will involve regular check-ups over 12 months to monitor your health. These check-ups will likely include medical assessments, discussions about your health, and possibly some questionnaires about your quality of life (called the EQ5D5L questionnaire). The total duration of your active participation, including follow-up, would be 12 months.

Potential risks and benefits

Participating in this study might offer the potential benefit of a treatment plan for your heart disease that is more tailored to you, potentially leading to better health outcomes and a reduced risk of serious heart problems. However, like all medical treatments, there are potential risks, primarily serious bleeding, which is a known side effect of blood-thinning medications. The study will carefully monitor for any such issues. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Netherlands

Common questions

What is PCI?

PCI stands for Percutaneous Coronary Intervention. It's a procedure to open narrowed or blocked arteries that supply blood to your heart.

What are Brilique and Clopidogrel?

These are both medicines known as blood thinners. They help prevent blood clots, which is important after a PCI procedure.

What does a 'genetic test' have to do with this?

The study is exploring if information from a genetic test can help doctors choose which blood thinner, Brilique or Clopidogrel, might work best for you.

What are the main things the researchers are looking at?

They are mainly watching for serious bleeding (safety) and serious heart problems like heart attacks, stroke, or clot in the stent (how well it works) over 12 months.

How long would I be involved in the study?

If you take part, you would be followed for 12 months.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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