Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Pharmacodynamic Outcomes in patients with coronary artery disease undergoing Percutaneous coronary intervention treated with an individualized treatment STRATEGY (POPular STRATEGY PD)

This study is for people in the UK who have stable coronary artery disease and have had a heart procedure called a stent (percutaneous coronary intervention, or PCI). After your stent, doctors usually prescribe blood-thinning medicines to stop new clots forming. This research aims to find out which of these commonly used medicines – like Efient, Plavix, or Brilique – works best for individual patients. Researchers will take blood samples to measure how well the medicine thins the blood and also keep a close eye on any bleeding or other heart-related problems. The goal is to help doctors pick the most effective and safest blood thinner for you after your heart procedure, to give you the best possible outcome.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

St Antonius Hospital

Enrolment target

Start

12 Jun 2023

Stable coronary artery disease Chronic coronary syndrome

What is this study about?

When you have a heart procedure like a stent (Percutaneous Coronary Intervention, or PCI), doctors insert a small mesh tube to open up a narrowed or blocked artery in your heart. To make sure this stent stays open and to prevent blood clots forming, you're usually given blood-thinning medicines. There are a few different types of these medicines, such as Efient, Plavix, and Brilique, often used alongside Aspirin.

This study, called POPular STRATEGY PD, is trying to find the best way to choose these blood-thinning medicines for people with stable coronary artery disease. Researchers want to see if they can use blood tests to measure how well a medicine is thinning your blood and then decide if that particular medicine is the best one for you. This could mean fewer side effects like bleeding, while still effectively preventing serious problems like heart attacks or strokes.

By carefully looking at how different medicines affect each person's blood and tracking any side effects or new heart problems, the study hopes to give doctors clearer guidance. This way, when you have a stent, your doctor can make a more informed decision about which blood-thinning medicine is most suitable for you, aiming for the best protection with the fewest risks.

Key takeaways

This study helps doctors choose the best blood-thinning medicine after a heart stent.
It aims to reduce serious problems like heart attacks or strokes, and also bleeding.
You'll receive standard, approved blood-thinning medicines.
The study involves extra blood tests to check how well your medicine is working.
Participation lasts for about six months, with close monitoring of your health.

Who may be eligible?

This study is looking for adults aged 18 or older. Both men and women can take part. To be considered, you must have stable coronary artery disease, which means you have a long-term heart condition where your heart's blood supply is reduced.

You also need to have recently undergone, or be about to undergo, a procedure called Percutaneous Coronary Intervention (PCI). This is the key medical treatment being investigated in relation to the blood-thinning medicines.

There might be other specific health requirements or conditions that would mean you couldn't join, or that your doctor would need to consider. It's always best to discuss your full medical history with the study team to see if you're a good fit.

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 18 years old or older?
Do you have stable coronary artery disease?
Have you recently had, or are you about to have, a heart stent procedure (PCI)?
Are you willing to take prescribed blood-thinning medicines?
Are you able to attend occasional study-related appointments for blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given one of the standard blood-thinning medicines (Efient, Plavix, or Brilique) along with Aspirin, which your doctor would prescribe anyway after your stent procedure. The main difference is that the study will involve extra blood tests to check how well your medicine is working.

You'll likely have a blood test around 30 days after you start taking the study medication. These tests will measure how 'sticky' your blood platelets are. The study team will also keep track of your health for a longer period, typically around six months, to monitor for any bleeding, heart attacks, strokes, or other problems. You may have additional check-ups or contact from the study team during this time. The total duration of active follow-up for most of the study's main goals is six months.

Potential risks and benefits

Participating in this study might offer potential benefits, such as very close monitoring of your blood-thinning treatment, which could lead to better choices being made for your individual care. The study uses medicines that are already approved and widely used, so you wouldn't be taking an entirely new or unknown drug. However, like all medicines, blood thinners can have side effects, with bleeding being a key risk. The study will carefully monitor for any bleeding incidents, from minor to more serious. You are always free to leave 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.

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Unverified
Netherlands

Common questions

What is a 'stent'?

A stent is a tiny mesh tube placed in a heart artery to keep it open after it's been widened, helping blood flow better.

Why do I need blood thinners after a stent?

Blood thinners help stop small blood cells called platelets from sticking together and forming clots, which could block your new stent.

What kind of medicines are being studied?

The study looks at common blood-thinning medicines like Efient, Plavix, and Brilique, which doctors already prescribe after a stent.

Will I have extra doctor's appointments?

You might have an extra blood test around 30 days after starting treatment, and the study team will monitor your health for about six months.

Can I stop being part of the study if I change my mind?

Yes, you can leave the study at any time without it affecting your regular medical care.