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Study on Reducing Antiplatelet Therapy in Patients with Acute Coronary Syndrome and High Bleeding Risk Using Prasugrel, Ticagrelor, or Clopidogrel

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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 the effects of different medications on patients who have experienced an Acute Coronary Syndrome (ACS), a condition where the blood supply to the heart is suddenly blocked. The study involves patients who have had a stent placed in their coronary arteries and are at a high risk of bleeding. The medications being tested include Ticagrelor, Acetylsalicylic Acid (commonly known as aspirin), Clopidogrel, and Prasugrel. These medications are known as antiplatelet drugs, which help prevent blood clots by stopping platelets, a type of blood cell, from sticking together.

The purpose of the study is to evaluate how different doses of these antiplatelet drugs affect platelet reactivity, which is how well the platelets respond to the medication. The study will compare lower doses of Prasugrel (5 mg), Ticagrelor (60 mg twice daily), and Clopidogrel (75 mg) with the full doses of Prasugrel (10 mg) and Ticagrelor (90 mg twice daily). The goal is to find out which treatment helps achieve the best balance in platelet activity, known as optimal platelet reactivity, without causing excessive bleeding.

Participants in the study will take the medications for a period of up to six months. During this time, their platelet reactivity will be monitored to see how the medications are working. The study will also track any bleeding events and other health outcomes, such as heart attacks or strokes, to understand the overall safety and effectiveness of the treatment regimens. This research aims to improve treatment strategies for patients with Acute Coronary Syndrome who are at high risk of bleeding, ensuring they receive the most effective and safe care possible.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Upon joining the study, the patient receives treatment with full-dose potent P2Y12 inhibitors. These include prasugrel at 10 mg or ticagrelor at 90 mg, taken twice daily. This phase is in accordance with international guidelines for patients who have recently experienced an acute coronary syndrome and undergone stent implantation.

  2. Step 2

    Randomization and treatment adjustment

    After the initial treatment phase, the patient is randomly assigned to one of three different treatment regimens. These regimens involve a reduction in the dosage of P2Y12 inhibitors to evaluate their effect on platelet reactivity.

    The options include prasugrel at 5 mg, ticagrelor at 60 mg taken twice daily, or clopidogrel at 75 mg. The goal is to determine which treatment achieves the optimal platelet reactivity at a steady state.

  3. Step 3

    Monitoring and assessment

    The primary endpoint is assessed 14±2 days after study inclusion. The patient's platelet reactivity is measured using the VerifyNow system, which provides a platelet reactivity unit (PRU) score. The optimal range is defined as a PRU between 85 and 208.

    Secondary endpoints include the incidence of bleeding events, categorized as nuisance, minor, or major, and other clinical events such as death, myocardial infarction, or stroke. These are monitored throughout the study and up to 5 months after randomization.

  4. Step 4

    Follow-up and final evaluation

    The study includes follow-up visits to assess adverse clinical events and other health outcomes. These visits occur at regular intervals up to 5 months after the initial randomization.

    Additional assessments may include health mobility and mental scales, perceived stress, and adherence to the treatment regimen.

Who can join the trial?

6 criteria

  • The patient must have signed and dated an Informed Consent, which is a document that explains the study and confirms the patient's agreement to participate.
  • The patient must be considered at HBR (High Bleeding Risk) based on standard definitions, such as having a PRECISE-DAPT score of 25 or more, or meeting the HBR-ARC criteria with at least one major or two minor conditions.
  • The patient must have been treated with PCI (Percutaneous Coronary Intervention), a procedure to open blocked heart arteries, due to a recent ACS (Acute Coronary Syndrome), which includes conditions like unstable angina or heart attacks, within the last 30 days, plus or minus 7 days.
  • The patient must have been treated with DAPT (Dual Antiplatelet Therapy) using full-dose potent P2Y12 inhibitors like prasugrel 10mg or ticagrelor 90mg twice a day, following international guidelines.
  • Both male and female patients are eligible to participate.
  • The study does not include vulnerable populations, which means it focuses on individuals who are not considered at additional risk due to their circumstances.

Who cannot join the trial?

3 criteria

  • Patients with a history of **acute coronary syndrome** cannot participate. This is a condition where the blood supply to the heart is suddenly blocked.
  • Patients who are not within the specified age range for the study are excluded. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population are not eligible. This means people who 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 recent heart attack or have undergone procedures like coronary stenting. It works by making the blood less sticky, which helps to reduce the risk of future heart-related problems.

  • Ticagrelor

    is another medication that helps prevent blood clots in patients with heart conditions. It is often used after a heart attack or stenting procedure to keep the blood flowing smoothly and reduce the risk of further heart issues.

  • Clopidogrel

    is a medication that helps prevent blood clots by stopping platelets in the blood from sticking together. It is commonly used in patients who have had a heart attack or have undergone procedures like coronary stenting to prevent future heart problems.

What is already known about the treatment

  • Prasugrel

    This medication is administered orally in tablet form and is used to prevent blood clots in patients who have undergone coronary stenting, particularly those with acute coronary syndrome. It is currently well-established in medical practice and literature as an antiplatelet agent. Prasugrel works by inhibiting the P2Y12 receptor on platelets, which reduces platelet activation and aggregation, thereby decreasing the risk of clot formation. It is classified as a thienopyridine antiplatelet drug.

  • Ticagrelor

    Administered orally in tablet form, ticagrelor is used to reduce the risk of cardiovascular events in patients with acute coronary syndrome. It is widely recognized in medical literature as an effective antiplatelet medication. Ticagrelor functions by reversibly binding to the P2Y12 receptor on platelets, preventing their activation and aggregation. This medication is classified as a cyclopentyltriazolopyrimidine antiplatelet agent.

  • Clopidogrel

    This medication is taken orally in tablet form and is used to prevent blood clots in patients with acute coronary syndrome or those who have had recent coronary stenting. Clopidogrel is well-documented in medical literature as an antiplatelet drug. It works by irreversibly inhibiting the P2Y12 receptor on platelets, which reduces their ability to clump together and form clots. It is classified as a thienopyridine antiplatelet agent.

Investigated diseases

Acute Coronary Syndrome – Acute coronary syndrome is a term used to describe a range of conditions associated with sudden, reduced blood flow to the heart. It often results from the buildup of fatty deposits in and on the walls of coronary arteries, which can rupture and form a clot. This can lead to chest pain or discomfort, often described as a feeling of pressure or tightness in the chest. The condition can also cause shortness of breath, nausea, or lightheadedness. It is a critical condition that requires immediate medical attention to restore blood flow and prevent heart damage. The progression of the disease can vary, but it often involves episodes of chest pain and may lead to more severe heart problems if not managed properly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509868-20-00Protocol codeDESC-HBREstimated enrolment200 patientsSponsorAzienda Ospedaliera Universitaria Gaetano Martino Messina

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