Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Evaluation of safety and efficacy of two ticagrelorbased de-escalation antiplatelet strategies in acute coronary syndrome: the randomized, multicenter, double-blind ELECTRA RCT study.

This research, called the ELECTRA RCT study, is comparing two ways of using blood-thinning medicines like Brilique and Aspirin after someone has had a heart attack or similar heart problem. The main goal is to find out which approach causes less serious bleeding. Researchers are looking at different doses of ticagrelor (the active ingredient in Brilique), along with Aspirin, to ensure patients get the right treatment. The study wants to see how safe and effective these different approaches are over 12 months, focusing on reducing the risk of bleeding complications without increasing other heart-related issues. It involves people aged 18 and over, making sure the medicines work well and are safe for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Nicolaus Copernicus University

Enrolment target

4,500

Start

24 Nov 2024

Acute Coronary Syndrom (ACS)

What is this study about?

When someone has a heart attack, doctors often prescribe medicines to prevent blood clots forming, which can cause more heart problems. Two common medicines for this are Aspirin and a drug called ticagrelor (often known by its brand name, Brilique). While these medicines are very good at preventing clots, they can also increase the risk of bleeding.

This study, called ELECTRA, is a large research project looking at two different ways of using these blood-thinning medicines after a heart attack. Researchers want to find out if using lower doses of ticagrelor, after an initial period with a higher dose, can reduce the risk of serious bleeding. They are comparing these strategies to see which one works best that helps prevent future heart issues but also keeps bleeding risks as low as possible. This is very important as it helps doctors tailor treatment more safely for each patient.

The main thing the study is watching for is how many serious bleeding events happen over 12 months. They classify bleeding from minor to very serious, including bleeding that needs medical attention, causes a significant drop in blood, or is life-threatening. By comparing these outcomes between the different treatment groups, the study aims to provide clear information on how to give these life-saving medicines more safely and effectively.

Key takeaways

The study aims to make blood-thinning treatments safer for heart attack patients.
It compares different uses of Brilique and Aspirin to reduce serious bleeding risks.
All participants receive closely monitored care for 12 months.
Participation helps scientists understand the best treatment strategies.
Your health and safety will be a top priority throughout the study.

Who may be eligible?

This study is open to anyone aged 18 or older, no matter their gender. You would be considered for this study if you've recently experienced a specific type of heart problem, such as a heart attack, where blood flow to your heart was suddenly blocked. The doctors would need to confirm that your particular heart condition fits the study's requirements.

There may be certain health conditions or medicines you are currently taking that would mean you couldn't join. For example, if you have a history of serious bleeding, another illness that might make the treatment unsafe, or if you're taking certain medications that could interact badly with the study drugs. All these factors would be carefully checked by the study doctors to make sure it's safe for you to take part.

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 had a heart attack or similar heart problem?
Are you able to attend regular follow-up appointments for about 12 months?
Are you generally in good health apart from your heart condition, without other serious illnesses?
Are you comfortable potentially taking different doses of blood-thinning medication as assigned by the study?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be given a combination of blood-thinning medicines, including Brilique and Aspirin, just like they are normally prescribed after a heart problem. The difference is that the specific dose of Brilique after an initial period will be determined by the study. Some participants will receive the standard dose, while others will receive a lower dose. You won't know which dose you're on, and neither will your doctors, to keep the study fair.

Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and to make sure the medicines are working well and you're not experiencing any unexpected side effects. You'll be closely monitored for any signs of bleeding. This will usually involve a series of appointments over about 12 months. Your study team will give you a clear schedule of when these visits will be and what will happen at each one.

Potential risks and benefits

Taking part in this study may offer the benefit of receiving very close medical attention and monitoring. You might also contribute to finding safer and more effective treatments for people who've had heart problems. However, there are potential risks, primarily related to the medicines being studied; blood thinners can increase the risk of bleeding, from minor bruising to more serious internal bleeding. While every precaution will be taken, there's a chance you might experience side effects. 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
Poland

Common questions

What is the main purpose of this study?

The main purpose is to compare different doses of blood-thinning medicines (Brilique and Aspirin) after a heart attack, to see which causes less serious bleeding while still preventing new heart problems.

What are 'bleeding events' that the study is looking for?

The study carefully tracks any bleeding, from obvious signs requiring a doctor's attention to more serious events like needing a blood transfusion, surgery, or very rarely, life-threatening bleeding.

Will I know which dose of medicine I am receiving?

No, neither you nor your study doctor will know which specific dose of Brilique you are receiving. This is to ensure the study results are fair and unbiased.

How long would I be involved in the study?

Your participation in the study would typically involve regular check-ups and monitoring over a period of 12 months.

Can I leave the study at any time?

Yes, you are free to stop participating in the study at any point, and your decision will not affect your ongoing medical care.