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Study on Prasugrel and Acetylsalicylic Acid for Patients with ST-Elevated Myocardial Infarction Undergoing Different Revascularization Techniques

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a heart condition known as ST-Elevated Myocardial Infarction (STEMI), which is a type of heart attack. The study is examining the effects of two medications: Acetylsalicylic Acid, commonly known as aspirin, and Prasugrel, an antiplatelet medication that helps prevent blood clots. The purpose of the study is to compare a treatment plan that starts with a combination of medications, including Prasugrel, for a short period, followed by Prasugrel alone, against a standard treatment plan.

Participants in the study will receive either the new treatment plan or the standard treatment plan. The study will last for about a year, during which the health of the participants will be monitored to see how well the treatments work. The study will also look at different ways of completing a procedure called revascularization, which helps restore blood flow to the heart. This will be done using either a method called Optical Coherence Tomography (OCT), which uses light waves to take pictures of the heart, or a standard method called angiography, which uses X-rays.

The main goal is to see if the new treatment plan is not worse than the standard plan in terms of preventing serious health problems like heart attacks, strokes, or bleeding. Additionally, the study aims to find out if using OCT for revascularization is better than using angiography in terms of the size of the area where a stent, a small tube used to keep blood vessels open, is placed. Participants will be followed up at different times to check for any major health events and to assess the success of the treatments.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting specific eligibility criteria. This includes experiencing chest discomfort due to a heart attack, confirmed by certain ECG features.

    Initial treatment involves addressing the main blocked artery during a procedure called PCI (Percutaneous Coronary Intervention).

  2. Step 2

    Initial treatment phase

    During the first 30-45 days, a combination of medications is administered. These include acetylsalicylic acid and prasugrel, both taken orally.

    This phase focuses on ensuring adherence to the medication regimen without any changes and monitoring for any significant health events.

  3. Step 3

    Medication adjustment

    After 30-45 days, if no major health events have occurred and the medication regimen has been followed, the treatment may shift to prasugrel alone.

    This adjustment is part of a strategy to reduce the combination of medications while maintaining effectiveness.

  4. Step 4

    Follow-up and monitoring

    Regular follow-ups are conducted to assess health outcomes, including the occurrence of any adverse events such as heart attacks, strokes, or bleeding.

    The effectiveness of the treatment is evaluated at various intervals, specifically at 2, 11, and 35 months after starting the study.

  5. Step 5

    Completion of the study

    The study is expected to conclude by July 2028, with ongoing assessments to ensure the safety and effectiveness of the treatment approach.

    Final evaluations will include a comprehensive review of health outcomes and any procedural results from the initial treatment phase.

Who can join the trial?

11 criteria

  • Patients must have experienced a **ST-Elevated Myocardial Infarction (STEMI)**, which is a type of heart attack.
  • Patients should have chest discomfort that suggests a problem with the heart's blood supply, lasting 20 minutes or more while at rest.
  • Patients must show specific changes on an **ECG (electrocardiogram)**, which is a test that checks the heart's electrical activity. These changes include ST segment elevation in at least two ECG leads or a new or likely new left bundle branch block.
  • For patients with **multivessel disease** (narrowing in more than one heart artery), only the main problem area should be treated during the initial procedure.
  • Patients must provide informed consent, meaning they agree to participate after understanding the study details.
  • Patients must follow the **DAPT (dual antiplatelet therapy)** without changing the treatment plan.
  • Patients should not have experienced any major events like another heart attack, unplanned procedures to restore blood flow, stent problems, stroke, or significant bleeding.
  • Patients must have had a successful procedure to restore blood flow, with less than 30% narrowing left in the treated areas.
  • If there are multiple problem areas, all should be treated within 15 days of the initial procedure, and checking blood flow in areas with 50% to 90% narrowing is recommended.
  • Both men and women can participate in the study.
  • Participants should not be from vulnerable populations, meaning they should not be in a situation where they are unable to make informed decisions.

Who cannot join the trial?

4 criteria

  • Patients who have had a recent heart attack with a specific type of heart damage called **ST-Elevated Myocardial Infarction**.
  • Patients who are not within the age range specified for the study.
  • Patients who are not part of the clinical trial groups specified for the study.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Prasugrel

    is a medication used to prevent blood clots in patients who have had a heart attack or other heart-related issues. In this trial, it is being tested to see if a short period of treatment with Prasugrel, followed by continued use of Prasugrel alone, is as effective as the standard treatment regimen. The goal is to determine if this approach can reduce the risk of bleeding while still preventing heart-related complications.

  • Optical Coherence Tomography (OCT)-guided revascularization

    is a technique used during heart procedures to get a detailed image of the inside of blood vessels. This helps doctors place stents more accurately and ensure that the blood vessels are opened properly. In this trial, OCT-guided revascularization is being compared to the standard method of using angiography to guide the procedure. The aim is to see if OCT can improve the outcomes by providing better visualization and more precise treatment.

What is already known about the treatment

Prasugrel – Prasugrel is administered orally in tablet form and is used primarily in the treatment of patients who have experienced a heart attack, specifically ST-Elevated Myocardial Infarction (STEMI). It is currently being studied in clinical trials to evaluate its effectiveness in a reduced dual antiplatelet therapy (DAPT) regimen followed by monotherapy. Prasugrel works by inhibiting platelet aggregation, which helps prevent blood clots. It belongs to the pharmacological class of antiplatelet agents, specifically P2Y12 inhibitors.

Investigated diseases

ST-Elevated Myocardial Infarction – This condition occurs when a coronary artery becomes completely blocked, leading to a significant reduction in blood flow to a part of the heart muscle. It is characterized by a specific pattern on an electrocardiogram (ECG) known as ST elevation. The blockage is usually caused by a blood clot that forms on a ruptured plaque in the artery. As the heart muscle is deprived of oxygen, it begins to suffer damage, which can lead to the death of heart tissue if not promptly addressed. Symptoms often include chest pain, shortness of breath, and discomfort in other areas of the upper body. The progression of the disease can lead to complications such as heart failure or arrhythmias if the blood flow is not restored quickly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515883-30-00Protocol codeRM21Estimated enrolment1 600 patientsSponsorResearch Maatschap Cardiologen Rotterdam Zuid

sourced from the EU Clinical Trials Register and site verification

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