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RecruitingPHASE4INTERVENTIONAL

Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients

This research is looking at better ways to treat patients in the UK who have had a serious type of heart attack called a STEMI. When you have a heart attack, doctors usually open up blocked blood vessels and then prescribe two anti-clotting medicines (Dual Antiplatelet Therapy or DAPT) for a while to prevent further clots. This study specifically investigates a common anti-clotting medicine called prasugrel. It compares whether taking a shorter course of this dual medicine therapy (about 1 to 1.5 months) followed by just prasugrel alone is as good — and potentially safer — than the standard, longer course of two medicines. It will compare how well people recover and if there are fewer side effects like bleeding. The study also explores the best way to open up other blocked blood vessels in the heart, if present, for some patients.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
Research Maatschap Cardiologen Rotterdam Zuid
Enrolment target
1,656
Start
22 Jul 2022
Estimated completion
01 Aug 2028

What is this study about?

When someone has a severe heart attack (what doctors call a STEMI), it means one of the main arteries supplying blood to their heart is completely blocked. Doctors act quickly to open this blocked artery, usually by inserting a small tube with a balloon to push the blockage aside and then placing a small mesh tube called a stent to keep it open. After this, to stop new clots forming, patients are typically given two anti-clotting medicines for a period of time – this is known as Dual Antiplatelet Therapy or DAPT.

This study wants to find out if there's an even better way to manage this anti-clotting treatment. Specifically, it's looking at a commonly used anti-clotting medicine called prasugrel. The main aim is to see if taking a shorter course of this dual therapy (around 1 to 1.5 months), followed by *only* prasugrel, is as safe and effective as the usual, longer course of two medicines. This could potentially reduce the risk of bleeding, which is a known side effect of anti-clotting medicines, while still protecting against further heart problems.

In some heart attack patients, not just one, but several heart arteries might be narrowed (this is called multi-vessel disease). For these patients, the study also includes a comparison of two ways doctors can guide the treatment of these other narrowed arteries: using special imaging called OCT (Optical Coherence Tomography) or relying on standard X-ray pictures (angiography). The goal is to see which method leads to better patient outcomes and safety.

Key takeaways

  • This study compares different anti-clotting medicine durations after a severe heart attack.
  • It tests if a shorter course of dual medicine (DAPT) followed by one medicine is safe and effective.
  • The main anti-clotting medicine being studied is prasugrel.
  • For some patients, it also looks at different ways to guide treatment of other narrowed heart arteries.
  • Patients are followed for almost 3 years to check health outcomes.
  • The aim is to find better ways to prevent future heart problems and reduce treatment side effects.

Who may be eligible?

To be considered for this study, you would first need to be admitted to the hospital with a severe type of heart attack called a STEMI, and your doctors must be planning to treat you with a procedure to open up your blocked heart artery. You would also need to show signs of a heart attack on an ECG (heart tracing).

If you have multiple narrowed heart arteries, doctors would initially only treat the main blocked one. Then, about 1 to 1.5 months later, if you've followed your DAPT medicine plan, haven't had any serious complications like another heart attack or major bleeding, and your initial procedure was successful, you might be eligible for the next stage of the study. This second stage is where you'd be randomly assigned to one of the treatment groups.

There are also some reasons why you might not be able to join. For example, if you're already taking medicines to thin your blood (anticoagulants), or if you've had a stroke or mini-stroke within the last year. Also, if you have certain severe liver problems, active bleeding, or a history of allergic reactions to the study medicines, you wouldn't be able to participate. Your doctor will carefully check all these points with you.

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.

  1. Have I recently had a severe heart attack (STEMI) that needs a procedure to open a blocked artery?
  2. Am I able to take aspirin and prasugrel?
  3. Have I had any strokes or mini-strokes in the last year?
  4. Do I have any active bleeding or severe liver problems?
  5. Am I currently taking other blood-thinning medications (anticoagulants)?
  6. Have I been compliant with my medications since my heart attack and not had any major complications yet?
Answer every question to see your result.

What does participation involve?

If you decide to take part, your journey would generally follow these steps:

1. **Initial Treatment:** When you first have your heart attack, you'll receive standard emergency treatment, including medicines like aspirin and prasugrel, and a procedure to open up your blocked artery. 2. **Addressing Other Narrowed Arteries (if needed):** If you have other narrowed arteries, these would typically be treated within 15 days of your first procedure. For some patients, the study will compare whether using a special camera (OCT) or standard X-ray imaging (angiography) to guide these extra treatments is better. 3. **Random Assignment (Month 1-1.5):** About 30-45 days after your initial heart attack treatment, if you meet all the criteria (e.g., no major complications, taking your medicines as prescribed), you'll be randomly assigned to one of two groups: either a shorter course of prasugrel plus another anti-clotting medicine followed by prasugrel alone, or the standard longer course of two anti-clotting medicines. 4. **Follow-up:** Your health will be carefully monitored for a long time – about 35 months (nearly 3 years) after you've been assigned to a treatment group. Your doctors will check in with you at 11 months and again at 35 months to see how you're doing and track any health outcomes.

Potential risks and benefits

Participating in research can offer potential benefits, such as receiving close medical monitoring throughout the study. This study is trying to find out if changes to standard treatment are as good or better, which could lead to improved care for future heart attack patients. However, like all medical treatments, there are potential risks. The medicines used can increase the risk of bleeding, and there's a chance of side effects, although these will be carefully monitored. The study also involves different approaches to opening arteries, each with its own risks. It's important to remember that joining a study is always your choice, and you are free to withdraw at any time without it affecting your medical care.

Locations (26)

  • Imelda Bonheiden
    Verified postcode
    Bonheiden, Belgium· Recruiting
  • AZ St.Jan
    Verified postcode
    Bruges, Belgium· Recruiting
  • ZOL Genk
    Verified postcode
    Genk, Belgium· Recruiting
  • UZ Leuven
    Verified postcode
    Leuven, Belgium· Not yet recruiting
  • AZ Delta
    Verified postcode
    Roeselare, Belgium· Recruiting
  • FN BRNO
    Verified postcode
    Brno, Czechia· Recruiting
  • Masaryk Hospital Usti nad Labem -
    Verified postcode
    Hradec Králové, Czechia· Not yet recruiting
  • Charles University Hospital
    Verified postcode
    Prague, Czechia· Not yet recruiting
  • Asklepios Klinik Bad Oldesloe
    Verified postcode
    Bad Oldesloe, Germany· Recruiting
  • Segeberger Kliniken
    Verified postcode
    Bad Segeberg, Germany· Recruiting
  • University hospital Dresden
    Verified postcode
    Dresden, Germany· Recruiting
  • Ospedale Papa Giovanni XXIII
    Verified postcode
    Bergamo, Italy· Recruiting

Common questions

What is a STEMI?

STEMI stands for ST-Elevation Myocardial Infarction. It's a severe type of heart attack where a major heart artery is completely blocked, causing heart muscle to die.

What is DAPT?

DAPT stands for Dual Antiplatelet Therapy. It's when doctors prescribe two different medicines to prevent blood clots, often after a heart attack or stent placement.

What is prasugrel?

Prasugrel is a powerful anti-clotting medicine often given to people after a heart attack to help prevent new blood clots from forming in their arteries or around stents.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, which means both you and your doctors will know which treatment group you are in (shorter course of DAPT then prasugrel alone, or standard DAPT).

What if I have other blocked arteries?

If you have other narrowed arteries, they will be treated, usually within 15 days of your first procedure. For some patients, the study will compare two different ways to guide these treatments.

How to find out more

Valeria Paradies, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monot…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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