Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

Randomized comparison of short versus 12 months prasugrel plus aspirin in patients with acute coronary syndromes treated with percutaneous coronary intervention and everolimus-eluting stents

This research trial compared two different approaches to medication after patients had a procedure called a PCI (Percutaneous Coronary Intervention) for a severe heart condition like a heart attack. All patients received a special type of stent. The main question was whether taking two anti-clotting medicines, prasugrel and aspirin, for just one month was as good as taking them for a full year. The study specifically looked at two things: how well the shorter period prevented complications like further heart problems or strokes, and if it caused less bleeding, which can be a side effect of these medicines. This information helps doctors understand the best way to treat patients after a stent.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Odense University Hospital

Enrolment target

3,150

Start

23 Aug 2024

Acute coronary syndromes

What is this study about?

This study is designed for people who have recently experienced a serious heart problem, such as a heart attack, and have had a procedure called a percutaneous coronary intervention (PCI). During a PCI, a doctor inserts a tiny mesh tube called a stent into a narrow or blocked heart artery to help keep it open. To prevent blood clots from forming in the stent, patients are usually prescribed two types of anti-clotting medicines, often aspirin and another drug like prasugrel.

Traditionally, these two blood-thinning medications are taken together for a longer period, sometimes up to 12 months. However, while these medicines are crucial for preventing serious issues like a new heart attack or stroke, they can also increase the risk of bleeding. This study wanted to find out if reducing the time a patient takes both medications together to just one month, instead of 12 months, would still be safe and effective.

The researchers carefully compared patients taking the medicines for one month versus 12 months. They looked at two main things: whether the shorter treatment time led to fewer serious bleeding events (this was the 'effectiveness' part) and if it was just as good at preventing serious heart-related problems like another heart attack, blood clots in the stent, or a stroke (this was the 'safety' part). The goal is to discover the best balance between preventing dangerous clots and minimising the risk of bleeding, ultimately improving care for people who have received a stent for a heart condition.

Key takeaways

Compares 1 month vs. 12 months of anti-clotting medicines (prasugrel + aspirin) after a heart stent.
Aims to see if shorter treatment is safer (less bleeding) and equally effective (prevents heart problems).
Looks at serious bleeding and serious heart/brain events.
For adults who've had a heart attack or similar and received an everolimus-eluting stent.
Participation involves taking medication and regular follow-up checks for 12 months.

Who may be eligible?

This study is looking for adult patients who have recently had a serious heart problem, like a heart attack, and have undergone a procedure called a PCI. This procedure involves placing a special type of stent in their heart's blood vessels.

To join, participants must be at least 18 years old. The study is open to both men and women.

There might be other specific health requirements or conditions that would make someone suitable or unsuitable for this trial. These details would be discussed with you by your doctor.

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 an adult (18 years or older)?
Have you recently had a heart attack or similar acute heart problem?
Have you had a PCI procedure where a special stent was placed?
Are you able to take prasugrel and aspirin?
Are you willing to be followed closely for 12 months?

Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, you would be randomly assigned to one of two groups. One group would take two anti-clotting medications (Hjertemagnyl/aspirin and Prasugrel Krka) for one month, while the other group would take them for 12 months. All medication would be provided as part of the study.

You would have regular check-ups and assessments to monitor your health, including any bleeding events or signs of other heart-related problems. These follow-up appointments would occur at specific times over the 12-month period after your PCI. Researchers would also be interested in how your quality of life changes and your symptoms of chest pain. The total duration of active follow-up for this study comparing the two treatment durations is 12 months after your PCI.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study could be finding that a shorter course of anti-clotting medication is just as effective and leads to less bleeding, which could improve future patient care. However, taking medication always carries risks of side effects, and changing treatment duration might increase or decrease certain risks for you. For example, reducing medication might slightly increase the risk of a clot, while continuing it for longer might increase the risk of bleeding. You have the right to withdraw from the study at any time, for any reason, without affecting your standard 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
Denmark

Common questions

What is a PCI?

PCI stands for Percutaneous Coronary Intervention. It's a procedure to open blocked or narrowed heart arteries, usually by inserting a small mesh tube called a stent.

What are prasugrel and aspirin?

These are medicines that help prevent blood clots. They are often prescribed together after a stent procedure to keep the stent open and prevent serious heart problems.

Why are they studying different treatment lengths?

Doctors want to find the best balance between preventing blood clots with these medicines and reducing the risk of bleeding, which is a common side effect. This study compares one month versus 12 months of treatment.

What is meant by 'clinically relevant bleeding'?

This refers to bleeding that is significant enough to require medical attention or intervention, as opposed to very minor bleeding which might not be a concern.

What are 'major adverse cardiovascular or cerebrovascular events'?

This is a medical term for serious problems with the heart or brain's blood vessels, such as a new heart attack, stroke, or a clot forming in the stent.