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Ticagrelor, Acetylsalicylic Acid and Prasugrel in Patients with Acute Coronary Syndrome: A Study of Antiplatelet Management

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What is this trial about?

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

The study focuses on people who have experienced an acute coronary syndrome, a condition that occurs when blood flow to the heart is suddenly reduced, often because of a clot. This is a type of ischemic heart disease. The trial compares three oral antiplatelet medicines that help keep platelets from sticking together and forming clots: PRASUGREL, acetylsalicylic acid, and ticagrelor. Some participants may receive a placebo, which looks the same as the medicine but contains no active drug.

The purpose of the study is to find out which of these treatments best prevents death, heart attack (also called myocardial infarction) or stroke during the first year after the heart event while also keeping serious bleeding low. Participants will take the assigned tablet once daily for up to 12 months and will attend scheduled visits to monitor their health.

During the year, participants will have regular visits where doctors check health, ask about any new problems, and record any occurrences of heart attack, stroke, death, or major bleeding. This information is used to compare the safety and effectiveness of the medicines.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After you agree to take part, you sign a consent form that explains the purpose of the study and what will be required of you.

  2. Step 2

    Baseline assessments

    The study team records your medical history, performs physical examinations, and may collect blood samples to establish your health status before treatment begins.

  3. Step 3

    Randomization to treatment group

    You are assigned, by a computer system, to receive one of the study medications. the assignment is made without your input to ensure fairness.

  4. Step 4

    Start of study medication

    You begin taking the medication that was assigned to you:

    prasugrel: 60 mg taken orally as directed in the study protocol.

    acetylsalicylic acid (aspirin): 100 mg taken orally as directed in the study protocol.

    ticagrelor: 180 mg taken orally as directed in the study protocol.

  5. Step 5

    Regular follow‑up visits

    Throughout the 12‑month follow‑up period you attend scheduled clinic visits where your health is checked, any side effects are recorded, and information about hospitalizations, heart attacks, strokes, or bleeding events is collected.

    The visits are spaced over the year to allow the study team to monitor safety and effectiveness of the medication.

  6. Step 6

    Final assessment at 12 months

    At the end of the 12‑month follow‑up you undergo a final evaluation that includes a physical exam, review of any health events that occurred, and collection of final data for the study outcomes.

Who can join the trial?

4 criteria

  • Be at least 18 years old (you must be an adult).
  • Have been admitted to the hospital because of an acute heart attack (called a myocardial infarction or MI). This includes both types known as STEMI (a more severe blockage) and NSTEMI (a less severe blockage).
  • During that hospital stay, you must have received invasive management that successfully opened the blocked artery using a procedure called percutaneous coronary intervention (PCI). This procedure can involve placing a small metal tube called a stent or inflating a tiny balloon inside the artery, including special drug‑coated balloons that release medication.
  • Be able to give informed consent (understand the study and agree to take part).

Who cannot join the trial?

12 criteria

  • You cannot join if you need to take long‑term oral anticoagulation therapy (blood‑thinning medicine taken by mouth).
  • You cannot join if you are planning an elective surgery (non‑emergency operation) that would require stopping a strong platelet‑blocking drug (potent P2Y12 inhibitor) within the next 12 months.
  • You cannot join if a doctor believes you have another health problem that would likely shorten your life expectancy to less than one year.
  • You cannot join if you are already enrolled in another clinical trial (research study testing a treatment).
  • You cannot join if you cannot tolerate, have a medical reason not to use, or are allergic to aspirin, ticagrelor, or prasugrel. (Intolerance means you react badly, contraindication means it is not safe for you, and allergy means your body reacts with an immune response.)
  • You cannot join if you have ever had an ischemic stroke (stroke caused by a blockage), a hemorrhagic stroke (stroke caused by bleeding), or a transient ischemic attack (a brief, stroke‑like episode).
  • You cannot join if you are currently experiencing active bleeding or have a known severe bleeding disorder (a condition that makes you prone to bleed heavily).
  • You cannot join if you have moderate or severe hepatic dysfunction (liver disease classified as Child‑Pugh class B or C).
  • You cannot join if you have a known intracranial aneurysm (bulge in a brain blood vessel), arteriovenous malformation (abnormal tangle of brain blood vessels), or neoplasm (brain tumor).
  • You cannot join if you have chronic kidney disease requiring dialysis (kidney failure that needs a machine to clean the blood).
  • You cannot join if you are pregnant, breastfeeding, or have childbearing potential (you could become pregnant).
  • You cannot join if you are taking medicines that act as CYP3A inhibitors or inducers (drugs that block or increase the activity of a liver enzyme that affects many medications).
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Investigated drugs

  • Prasugrel

    is a pill that helps stop blood cells called platelets from sticking together and forming clots. In this study, it is being tested to see if it can lower the chance of death, heart attacks, or strokes in people who have recently had a heart problem called an acute coronary syndrome.

  • Acetylsalicylic acid

    (commonly known as aspirin) combined with dipyridamole is taken by mouth to reduce the ability of platelets to clump together. This combination is being evaluated in the trial to determine whether it can safely reduce the risk of serious events such as death, heart attacks, or strokes after a recent heart episode.

  • Ticagrelor

    is an oral medication that blocks a specific receptor on platelets, preventing them from forming clots. The trial is testing whether ticagrelor can effectively lower the risk of death, non‑fatal heart attacks, or strokes in patients who have experienced an acute coronary syndrome.

What is already known about the treatment

  • PRASUGREL

    This medication is taken by mouth as a tablet and is approved and widely used for preventing blood clots in people with heart disease. It is mainly prescribed after a heart attack or during procedures that may cause clots. Prasugrel works by blocking a specific receptor (P2Y12) on platelets, which stops them from sticking together. It belongs to the class of antiplatelet drugs, specifically P2Y12 receptor inhibitors.

  • ACETYLSALICYLIC ACID

    This oral tablet contains aspirin together with dipyridamole and is an established treatment for reducing clot risk in patients with coronary artery disease. It is commonly used to lower the chance of heart attacks and strokes. Aspirin blocks an enzyme (COX‑1) that makes platelets sticky, while dipyridamole raises levels of a natural chemical that further prevents platelet clumping. The combination is classified as an antiplatelet agent, combining a COX inhibitor and a phosphodiesterase inhibitor.

  • TICAGRELOR

    Taken orally as a tablet, ticagrelor is an approved medication for preventing clot formation after acute coronary events. It is indicated for patients with recent heart attacks or those undergoing certain heart procedures. Ticagrelor reversibly blocks the P2Y12 receptor on platelets, which reduces their ability to aggregate. It is categorized as a reversible P2Y12 receptor antagonist, a type of antiplatelet drug.

Investigated diseases

Ischemic heart disease - Ischemic heart disease is a condition in which the heart muscle does not receive enough oxygen‑rich blood because the coronary arteries become narrowed or blocked. The narrowing usually develops slowly over many years due to a buildup of fatty deposits on the artery walls. As blood flow is reduced, people may experience chest discomfort during physical activity or stress. Over time the disease can progress from stable chest pain to episodes of sudden blockage that cause a heart attack. Continued reduction in blood supply can weaken the heart muscle and lead to reduced pumping ability.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525933-22-00Estimated enrolment3 500 patientsSponsorInstituto De Investigacion Sanitaria Fundacion Jimenez Diaz

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