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Prevention of Left Ventricular Thrombosis in Patients with Acute Anterior Myocardial Infarction Using Fondaparinux plus Standard Drug Combination

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

The study focuses on patients who have experienced an Acute myocardial infarction affecting the front part of the heart and resulting in reduced heart pumping ability. The medication being tested is fondaparinux, given as a small injection under the skin once a day for up to ten days. All participants also receive the usual blood‑thinning drugs, which may include acetylsalicylic acid, prasugrel, clopidogrel or ticagrelor. These medicines help prevent clots by reducing the ability of platelets to stick together.

The purpose of the trial is to find out whether adding fondaparinux lowers the chance of a blood clot forming in the heart chamber, known as ventricular thrombosis, during the first month after the heart attack, while also monitoring for serious bleeding. After the heart attack and a routine procedure to open the blocked artery, patients are assigned to receive either the test medication or the standard regimen. Doctors will perform heart ultrasounds using a special dye (echocardiography) at several points—about one day, three days, ten days, and thirty days after the event—to look for clots. Some participants may also have a detailed heart scan for additional information. The study follows each participant for roughly one month, with scheduled visits at the same time points to collect safety and health information.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Baseline Evaluation

    After joining the study, you will undergo baseline assessments that include a review of your medical history, a physical examination, blood tests, and an initial contrast‑enhanced echocardiogram to evaluate heart function.

  2. Step 2

    Start Standard Antithrombotic Therapy

    You will begin oral aspirin 100 mg taken once daily.

    In addition, you will take one of the following oral P2Y12 inhibitors once daily, as prescribed by the investigator: prasugrel 10 mg, clopidogrel 75 mg, or ticagrelor 180 mg.

    These medications are started within three hours after the primary PCI (percutaneous coronary intervention) procedure.

  3. Step 3

    Begin Study Injection (Test Group)

    If you are assigned to the test group, you will receive a subcutaneous injection of fondaparinux sodium 2.5 mg (provided as a 2.5 mg/0.5 ml pre‑filled syringe) once daily.

    The first injection is given on the day of enrollment and you will continue the daily injection through Day 10 inclusive.

  4. Step 4

    Daily Monitoring for Safety

    You will be asked to monitor for signs of bleeding, such as unusual bruising, blood in urine or stool, or prolonged bleeding from cuts, and to report any such symptoms to the study team promptly.

  5. Step 5

    First Imaging – Day 1

    Twenty‑four hours (Day 1) after the procedure, you will undergo a contrast‑enhanced echocardiogram to assess for left‑ventricular thrombus.

  6. Step 6

    Second Imaging – Day 3

    Seventy‑two hours (Day 3) after the procedure, a second echocardiogram will be performed using the same technique.

  7. Step 7

    Third Imaging – Day 10

    Two hundred and forty hours (Day 10) after the procedure, a third echocardiogram will be carried out.

    If you are participating in the cardiac‑MRI (CMR) sub‑study, you will also have a cardiac magnetic resonance scan scheduled around Day 10, give or take two days.

  8. Step 8

    Continue Oral Medications

    You will continue taking oral aspirin and the prescribed P2Y12 inhibitor every day until at least Day 30, unless instructed otherwise by your physician.

  9. Step 9

    Final Follow‑up – Day 30

    On Day 30 you will attend a final clinic visit that includes a last contrast‑enhanced echocardiogram, a review of any bleeding events that occurred during the study, and collection of outcome data.

  10. Step 10

    End of Study Participation

    After the Day 30 visit, your participation in the trial concludes. You will complete any remaining study questionnaires and receive a summary of the study results.

Who can join the trial?

3 criteria

  • Be at least 18 years old.
  • Have experienced an anterior STEMI (a heart attack that affects the front part of the heart) with reduced movement at the tip of the heart (apical dysfunction) after a procedure called primary angioplasty (also known as primary PCI, which opens the blocked artery), and meet at least one of these conditions: the angioplasty was done more than 12 hours after symptoms started, the blood flow after the procedure was less than optimal as measured by a TIMI flow score below 3 or a myocardial blush grade (MBG) below 3, or the overall pumping ability of the heart was low with an ejection fraction (EF) under 45%.
  • Provide informed consent (agree to take part after understanding the study), or if unable to sign because of the emergency, have consent obtained following the emergency consent procedure.

Who cannot join the trial?

19 criteria

  • You cannot join the study if there is any reason you must not take fondaparinux, such as currently bleeding (active bleeding) or being allergic to it (hypersensitivity).
  • You cannot join if your kidneys are very weak, measured as an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m².
  • You cannot join if you are already taking a regular oral blood‑thinner (chronic oral anticoagulation) for another condition.
  • You cannot join if you have a known bleeding disorder (coagulopathy) or a very low platelet count (severe thrombocytopenia).
  • You cannot join if you need a blood‑thinner for a medical reason other than this study (therapeutic anticoagulation).
  • You cannot join if you are pregnant or breastfeeding.
  • You cannot join if an ultrasound of your heart already shows a clot inside the left ventricle (LVT) before the study starts.
  • You cannot join if you cannot have a cardiac MRI (CMR) because you have a severe allergy to the contrast agent gadolinium.
  • You cannot join if you have a very high risk of bleeding, measured by a CRUSADE bleeding risk score greater than 40.
  • You cannot join if you have an active infection of the heart valves (acute bacterial endocarditis).
  • You cannot join if you have ever had bleeding inside the brain (intracranial haemorrhage).
  • You cannot join if you had a serious stomach, intestinal, urinary or genital bleed (gastrointestinal or genitourinary bleeding) in the past three months.
  • You cannot join if you had major surgery, major trauma, brain or spinal surgery, or eye surgery (intraocular surgery) in the past 30 days, or if such surgery is planned while you are on the study drug.
  • You cannot join if you are already participating in another clinical trial that used a new drug (interventional clinical trial) within the past 30 days or within five half‑lives of that drug.
  • You cannot join if you weigh less than 45 kg (about 99 lb).
  • You cannot join if doctors expect you to live less than six months for reasons not related to your heart condition (life expectancy <6 months).
  • You cannot join if you received clot‑busting medication (fibrinolytic therapy) for this heart attack, or if it was given within the last 24 hours.
  • You cannot join if you cannot receive the special contrast agents used with ultrasound (ultrasound enhancing agents).
  • You cannot join if you are allergic to gadolinium‑based contrast agents used in imaging.
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Investigated drugs

  • Aspirin

    is a medication that helps prevent blood cells called platelets from sticking together and forming clots. In this study it is used as a standard comparison treatment that patients normally receive after a heart attack.

  • Prasugrel

    is a stronger antiplatelet medicine that also stops platelets from clumping. It is given by mouth and is used in the trial as another standard therapy to compare against the new treatment.

  • Clopidogrel

    is a common antiplatelet drug that reduces the risk of clot formation after a heart attack. It is taken orally and serves as a comparator in the study.

  • Ticagrelor

    is an antiplatelet medication that works quickly and can be reversed if needed. It is taken by mouth and is included in the trial as one of the standard treatments for comparison.

  • Fondaparinux

    is an anticoagulant that works by stopping a part of the clotting process in the blood. In this trial it is given as a small injection under the skin once a day for up to ten days after a heart attack. The study is testing whether fondaparinux can lower the chance of a clot forming in the heart’s left ventricle while still being safe and not causing too much bleeding.

What is already known about the treatment

  • Acetylsalicylic Acid

    This medication is taken by mouth as a tablet, usually 100 mg. It is a well‑known drug that has been used for many years to help prevent heart attacks and strokes. It works by blocking an enzyme that makes a substance which makes platelets stick together, thus reducing clot formation. It belongs to the class of non‑steroidal anti‑inflammatory drugs and antiplatelet agents.

  • Prasugrel

    Prasugrel is an oral tablet taken at a dose of 10 mg. It is a newer antiplatelet medicine that is approved for use after procedures that open blocked heart arteries. It prevents clots by permanently turning off a receptor on platelets called P2Y12, which stops the platelets from joining together. It is classified as a thienopyridine antiplatelet drug.

  • Fondaparinux Sodium

    Fondaparinux is given as a subcutaneous injection of a clear solution, 2.5 mg each day. It is an approved synthetic anticoagulant used to stop clot formation after heart procedures and in other high‑risk situations. It works by helping a natural protein called antithrombin block a clotting factor called factor Xa, which stops the clotting cascade. It is classified as a synthetic pentasaccharide anticoagulant.

  • Clopidogrel

    Clopidogrel is taken orally as a 75 mg tablet. It is an established medicine for preventing clots after heart attacks and after stent placement. It reduces clot risk by permanently blocking the P2Y12 receptor on platelets, which keeps them from sticking together. It belongs to the thienopyridine class of antiplatelet drugs.

  • Ticagrelor

    Ticagrelor is an oral tablet taken at a dose of 180 mg. It is a newer antiplatelet drug approved for people with acute coronary syndrome. It works by reversibly blocking the P2Y12 receptor on platelets, which stops platelets from forming clots. It is classified as a cyclopentyltriazolopyrimidine antiplatelet agent.

Investigated diseases

Acute anterior myocardial infarction with systolic dysfunction - It is a sudden blockage of a coronary artery that supplies the front part of the heart, causing damage to the heart muscle. The blockage leads to death of heart cells, which reduces the heart’s ability to contract. This reduced contraction, called systolic dysfunction, means the heart pumps less blood with each beat. Over the next days to weeks the damaged area may become scar tissue and the pumping ability can remain low. The weakened heart can cause fluid buildup, shortness of breath, and fatigue as it works harder to move blood. If the pumping function does not improve, the condition may develop into chronic heart failure.
Trial detailsLast updated 23 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524664-38-00Estimated enrolment298 patientsSponsorAzienda Unita' Sanitaria Locale Toscana Sud Est

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