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Study comparing high-dose and low-dose aspirin with prasugrel and aspirin combination in patients after coronary artery bypass grafting surgery

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What is this trial about?

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

This clinical trial focuses on patients with coronary artery disease who undergo coronary artery bypass grafting (CABG), a surgery that improves blood flow to the heart by creating new pathways around blocked arteries. The study aims to compare different approaches to preventing graft failure after surgery using blood-thinning medications.

The study examines three different treatment combinations: acetylsalicylic acid (also known as aspirin) at a low dose (75 mg) plus prasugrel (10 mg), aspirin alone at a high dose (300 mg), or aspirin alone at a low dose (75 mg). These medications help prevent blood clots from forming in the newly created bypass grafts. The treatment period with these specific combinations lasts for three months, after which all patients continue with low-dose aspirin only.

The research will track how well the bypass grafts remain open over time and monitor for complications such as bleeding, heart attacks, or the need for additional procedures. Patients will be followed for 12 months after their surgery to evaluate the effectiveness and safety of these different medication combinations.

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

    Initial treatment phase

    After coronary artery bypass surgery (CABG), you will be randomly assigned to one of three medication groups:

    Group 1: Low-dose aspirin (75mg daily) plus prasugrel (10mg daily)

    Group 2: High-dose aspirin (300mg daily)

    Group 3: Low-dose aspirin (75mg daily)

    This initial phase lasts for 3 months

  2. Step 2

    Continuation phase

    After the first 3 months, all patients will continue with low-dose aspirin (75mg daily) only

    This phase continues until the end of the study

  3. Step 3

    Follow-up examinations

    Regular check-ups will occur at 6 months and 12 months after starting the study

    Doctors will monitor your heart health and check for any side effects

    You will complete quality of life questionnaires during these visits

  4. Step 4

    Final evaluation

    At 12 months, doctors will examine how well your bypass grafts are working

    This examination will help determine the effectiveness of the different medication combinations

    The study will track your health outcomes including heart-related events and recovery progress

  5. Step 5

    Long-term monitoring

    Additional follow-up may continue beyond the initial 12-month period

    Doctors will continue to monitor your overall health and any heart-related events

    The total study duration may extend until April 2029

Who can join the trial?

13 criteria

  • Must be over 18 years of age
  • Must be scheduled for coronary artery bypass surgery (CABG) with at least 2 bypass grafts for stable heart disease
  • Must have at least one of these heart vessel problems:
    • Narrowing of heart arteries by 70% or more
    • Narrowing of the main heart artery by 50% or more
    • Abnormal blood flow measurements in heart vessels
    • Must be able to follow all study procedures and attend follow-up visits
    • Must sign an informed consent form
    • During surgery:
      • All bypass grafts must show normal blood flow
      • Must receive an internal thoracic artery graft to the front heart vessel
      • Must not need additional procedures during surgery
      • Must not need removal of blockages from inside the vessels
      • Must not need any unplanned additional heart procedures
      • Must not need any additional heart procedures after surgery

Who cannot join the trial?

15 criteria

  • History of allergic reactions to aspirin or prasugrel
  • Active bleeding or high risk of bleeding
  • Previous stroke or mini-stroke (transient ischemic attack)
  • Emergency or urgent cardiac surgery
  • Severe liver disease (problems with liver function)
  • Currently taking blood-thinning medications other than those in the study
  • Recent major surgery within the last 3 months
  • Blood disorders that increase bleeding risk
  • Scheduled to have another surgery within 3 months after CABG
  • Participation in another clinical trial
  • Inability to follow study procedures or attend follow-up visits
  • Pregnancy or planning to become pregnant during the study period
  • Kidney failure requiring dialysis
  • Uncontrolled high blood pressure
  • Active stomach or intestinal ulcers
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Investigated drugs

  • Aspirin

    (ASA) is a commonly used medication that helps prevent blood clots. It works by making blood platelets less sticky, which reduces the risk of clots forming in blood vessels and grafts after heart surgery. In this trial, both low-dose and high-dose versions are being studied.

  • Prasugrel

    is a medication that works together with aspirin to prevent blood clots. It is more potent than aspirin alone and is often used in patients who have had heart procedures. It helps keep the blood vessels and surgical grafts open after coronary bypass surgery by preventing platelets from sticking together.

What is already known about the treatment

  • Aspirin

    A widely used antiplatelet medication administered orally in tablet form that helps prevent blood clots and reduce the risk of cardiovascular events. This medication works by inhibiting platelet aggregation through the irreversible inhibition of cyclooxygenase enzymes, reducing the production of thromboxane A2. In coronary artery bypass grafting (CABG) patients, it is used to prevent graft failure and reduce the risk of thrombotic complications, with different dosing regimens (high-dose vs. low-dose) being studied for optimal effectiveness.

  • Prasugrel

    A potent oral antiplatelet medication belonging to the thienopyridine class, which is used in combination with aspirin as dual antiplatelet therapy following cardiac procedures. It works by irreversibly blocking the P2Y12 receptor on platelets, preventing their activation and aggregation, thus reducing the risk of blood clot formation. In CABG patients, prasugrel is being studied in combination with low-dose aspirin to evaluate its effectiveness in preventing graft failure and improving outcomes after surgery.

Investigated diseases

  • Coronary Artery Disease

    A condition where the blood vessels supplying the heart become narrowed or blocked due to the buildup of fatty deposits called plaque. This chronic condition develops gradually over time as cholesterol and other substances accumulate in the arterial walls. The narrowing of arteries reduces blood flow to the heart muscle, which can cause chest pain (angina) during physical activity. The disease can affect multiple coronary arteries simultaneously, leading to reduced heart function. As the disease progresses, the arteries become increasingly narrow, potentially affecting daily activities.

  • Chronic Coronary Syndrome

    A stable form of coronary artery disease characterized by predictable episodes of chest discomfort or shortness of breath. The condition typically occurs during physical exertion or emotional stress when the heart needs more oxygen than the narrowed arteries can provide. Between episodes, patients may feel normal and have no symptoms. The pattern of symptoms usually remains stable over time without sudden worsening. This condition represents the stable phase of coronary artery disease where symptoms are relatively predictable and manageable.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521892-30-00Protocol code2024/ABM/01/00016Estimated enrolment1 703 patientsSponsorAgencja Badań Medycznych

sourced from the EU Clinical Trials Register and site verification

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