Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Ticagrelor monotherapy after coronary stenting in patients with acute myocardial infarction - A prospective single-centre, single-arm phase II study

This study is investigating a new way to treat people who have recently experienced a heart attack and had a small tube called a stent placed in their heart to keep an artery open. The research focuses on a medication called Brilique (ticagrelor), given as tablets. Doctors want to see if taking Brilique on its own, without other similar medications, can help prevent serious heart problems. These problems include another heart attack, death related to the heart, or blood clots forming in the stent within three months of their initial heart attack. This is a Phase II study, meaning it's an early step to gather information about the drug's effects and safety.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Vaestra Goetalandsregionen

Enrolment target

200

Start

11 Jun 2024

Myocardial infarction

What is this study about?

This clinical trial is designed for people who have recently had a heart attack, which is when the blood supply to part of the heart is suddenly blocked. Often, after a heart attack, doctors will insert a small mesh tube called a stent into the affected artery to help keep it open. This study is looking at a specific medication called Brilique, given as tablets. Usually, after a stent is placed, patients might take a combination of medicines to prevent blood clots.

In this study, researchers want to see if Brilique taken by itself, without other similar medications, can effectively prevent serious heart-related problems. These problems include another heart attack, death from heart-related causes, or the formation of blood clots inside the stent. They are particularly interested in what happens within the first three months after a heart attack and stent placement. This is important because preventing these complications can significantly improve a person's recovery and long-term health.

This is a 'Phase II' study, which means it's an early-stage trial. Doctors are carefully exploring whether this treatment approach is promising and safe before moving on to larger studies. The overall goal is to find better ways to protect people's hearts after a heart attack.

Key takeaways

This study is for people who've had a heart attack and a stent.
It's testing if Brilique on its own can prevent future heart problems.
The main focus is on preventing complications within 3 months.
It's an early-stage study to learn more about this treatment approach.
Participants will be closely monitored for up to 12 months.

Who may be eligible?

To be considered for this study, you would need to be 18 years old or over. There is no upper age limit, meaning people of all adult ages could potentially join. Both men and women are welcome to take part in this research.

You would specifically be considered if you have recently experienced a heart attack and have had a stent fitted to help your heart artery. The study is particularly looking for people who are in this specific situation.

The research team will need to check your full medical history and current health to make sure that taking part in the study is right and safe for you.

Quick self-check

Are you 18 years old or older?
Have you recently had a heart attack?
Have you had a stent fitted in your heart?
Are you able to take tablets as prescribed?

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 would be given the study medication, Brilique 90 mg tablets, to take. The study team would closely monitor your health over a period of up to 12 months. This would involve regular visits to the hospital or clinic, where doctors and nurses would perform various health checks and tests. These might include blood tests to check how your blood is clotting and how the medication is affecting you. They would also ask questions about your health and any symptoms you might be experiencing. The main focus is to check your health at 3 months and then again at 12 months after starting the treatment.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving close medical monitoring and access to a medication under controlled conditions. This could help doctors understand if a new treatment approach is safer and more effective for people like you. However, there are also potential risks, like any medication, Brilique can have side effects, including an increased risk of bleeding. The research team would explain these fully. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Sweden

Common questions

What is a stent?

A stent is a tiny tube that doctors place in a blocked or narrowed artery in your heart to help keep it open and improve blood flow.

What is Brilique (ticagrelor) for?

Brilique is a medication used to help prevent blood clots from forming in your blood vessels, especially after a heart attack or stent placement.

What kind of heart problems are they looking for?

Researchers are looking to see if Brilique can prevent another heart attack, prevent blood clots in your stent, or reduce the risk of heart-related death.

How long does the study last?

The study will follow your health for up to 12 months, with key checks at 3 months and 12 months after you start the medication.

Will I have to pay to take part?

No, you will not have to pay to take part in the study. All study-related medication and assessments will be provided free of charge.