AuthorisedTherapeutic use (Phase IV)Interventional

PhARMacodynamics of earlY versus Delayed Administration of TIcagrelor during CAngrelor infusion in patients with acute ST-segment elevation Myocardial Infarction: a randomized superiority study

This study, called PHARMACY, is looking at the best time to give a common heart medication called ticagrelor (also known as Brilique) to patients who have just had a serious type of heart attack called a STEMI. These patients are also receiving another heart medication called cangrelor (Kengrexal) during a procedure to unblock their arteries. The main goal is to see if giving ticagrelor earlier rather than later, after the cangrelor treatment has stopped, helps prevent blood clots from forming in the arteries. Researchers will check this by looking at how well platelets (tiny blood cells involved in clotting) are working. The study also aims to understand if the timing affects other important outcomes like further heart problems, the need for more procedures, or any bleeding issues.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Enrolment target

Start

13 Aug 2024

ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI)

What is this study about?

When someone has a serious heart attack (called a STEMI), doctors often perform an emergency procedure to open up blocked arteries. During this procedure, and sometimes for a short time afterwards, patients are given a powerful anti-clotting medicine called cangrelor (Kengrexal) through a drip. After the drip is stopped, patients typically switch to a tablet form of anti-clotting medicine, like ticagrelor (Brilique), which they take for a longer period.

This study, named PHARMACY, wants to find out the best timing for giving this ticagrelor tablet. Specifically, it's comparing whether giving the ticagrelor earlier, while the cangrelor drip is still running, or waiting until the cangrelor drip has finished, makes a difference. The main thing they are trying to measure is whether one timing is better at preventing blood clots from forming after the procedure, by checking how active the patient's blood platelets (which cause clotting) are.

It's important to understand this because preventing blood clots is vital for heart attack patients. If clots form, they can lead to more heart problems or even another heart attack. By carefully studying different timings for this medication, researchers hope to find the safest and most effective way to help patients recover and reduce their risk of future problems. They will also be looking at other important outcomes like how many people have further heart events or experience bleeding.

Key takeaways

This study compares different timings for giving anti-clotting medication to heart attack patients.
It focuses on patients with a serious heart attack (STEMI) undergoing a procedure to unblock arteries.
The main goal is to see if earlier medication delivery helps prevent blood clots better.
Researchers will also track other important outcomes like heart problems and bleeding.
Participation would involve specific timing of medication and extra blood tests.

Who may be eligible?

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

The most important requirement is that you have just had a specific type of serious heart attack called an ST-elevation myocardial infarction (STEMI) and are preparing to have a procedure to open up your blocked heart arteries (called primary percutaneous coronary intervention, or PCI).

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?
Have you recently experienced a serious heart attack called a STEMI?
Are you about to have an emergency procedure to unblock your heart arteries (PCI)?
Are you able to follow study instructions and attend follow-up appointments (if any are outside the hospital stay)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will already be in hospital for a heart attack. You would be assigned to receive your ticagrelor medication at a slightly different time than usual, either earlier or later, depending on which group you are in. Doctors will closely monitor your blood to see how well the anti-clotting medications are working, specifically looking at how your platelets behave. This will involve taking blood samples at specific times after your treatment.

Researchers will also keep a close eye on your overall health for about a month (30 days) after your procedure. They will check for any further heart problems, any need for additional procedures, and any signs of bleeding. The total duration of active follow-up for the study will be this 30-day period.

Potential risks and benefits

Potential benefits of taking part could include contributing to a better understanding of how to treat heart attack patients, potentially leading to improved care for future patients. For you personally, your care will be closely monitored. As with any medical treatment, there are potential risks, mainly related to the anti-clotting medications themselves, such as an increased risk of bleeding. This study involves standard medications, but the timing is being investigated. You have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Italy

Common questions

What is a STEMI heart attack?

A STEMI is a very serious type of heart attack where a main artery supplying blood to the heart is completely blocked. It needs urgent treatment.

What do the medications Brilique and Kengrexal do?

Both Brilique (ticagrelor) and Kengrexal (cangrelor) are medicines that help prevent blood clots from forming, which is very important after a heart attack to keep your arteries open.

Why is the timing of these medications important?

The study aims to find out if giving these anti-clotting medicines at different times makes them work better to prevent clots, or if it changes the risk of bleeding.

Will I know which group I am in?

The study doesn't specify if you will know, as these types of studies are often 'blinded' to ensure unbiased results. You can ask the study team if this information is available to participants.

What are 'platelets' and why are they measured?

Platelets are tiny cells in your blood that help it clot. After a heart attack, we want to make sure they're not too active, otherwise they could form harmful clots. The medication helps control them, and measuring them shows how well the medicine is working.