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Study on the Effects of FDY-5301 for Patients with Anterior ST-Elevation Myocardial Infarction (Heart Attack)

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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 Anterior ST-Elevation Myocardial Infarction (STEMI), which is a type of heart attack. The study is testing a treatment called FDY-5301, which is a solution for injection containing sodium iodide. This treatment is being compared to a placebo, which looks like the treatment but does not contain the active substance. The purpose of the study is to understand how FDY-5301 affects heart-related deaths and heart failure events in patients who have experienced this type of heart attack.

Participants in the study will receive either the FDY-5301 treatment or a placebo through an intravenous injection, which means it is given directly into a vein. The study is designed to be "double-blind," meaning neither the participants nor the researchers know who is receiving the actual treatment or the placebo. This helps ensure that the results are not influenced by expectations about the treatment's effects. The study will follow participants for up to 12 months to monitor for any heart-related events, such as heart failure or additional heart attacks.

The main goal is to see if FDY-5301 can reduce the number of heart-related deaths and heart failure events compared to the placebo. Secondary goals include looking at the overall number of heart-related events and measuring levels of a heart-related protein called troponin T on the third day after treatment. This study aims to provide valuable information on the potential benefits of FDY-5301 for patients who have suffered from a heart attack.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age and symptoms of a heart attack, known as an anterior ST-elevation myocardial infarction (STEMI).

    Consent is obtained after approval from an ethics committee.

  2. Step 2

    Initial treatment

    The study involves the administration of an intravenous solution, either the investigational drug FDY-5301 or a placebo that looks similar.

    The solution is given through a vein, known as intravenous use.

  3. Step 3

    Monitoring and follow-up

    Participants are monitored for cardiovascular events, such as heart failure or heart-related deaths, over a period of 12 months.

    Regular assessments include checking for any heart-related issues and measuring levels of a heart enzyme called troponin T on the third day.

  4. Step 4

    Completion of the study

    The study is expected to conclude by June 2025.

    Final evaluations are conducted to assess the overall impact of the treatment on heart health.

Who can join the trial?

4 criteria

  • Must be at least 18 years old.
  • Must have an anterior STEMI, which is a type of heart attack. This is determined by symptoms like chest pain, shortness of breath, jaw pain, arm pain, sweating, or similar signs. It is also confirmed by an Electrocardiogram (ECG)
  • Must have a planned primary PCI, which is a procedure to open blocked heart arteries, within 6 hours of the start of symptoms that led to seeking medical care for the heart attack.
  • Must have given consent to participate in the study, approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC), which are groups that review and approve research studies to ensure they are ethical and safe.

Who cannot join the trial?

5 criteria

  • Patients who have had a heart attack that is not an anterior ST-Elevation Myocardial Infarction (STEMI). This is a specific type of heart attack that affects the front part of the heart.
  • Patients who are not undergoing pPCI, which stands for primary percutaneous coronary intervention. This is a procedure to open blocked heart arteries.
  • Patients who are outside the specified age range for the study. The study is looking for participants within certain age groups.
  • Patients who are not part of the specified clinical trial groups. The study is targeting specific groups of people.
  • Patients who are considered part of a vulnerable population. This means people who might need special protection or care.
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Investigated drugs

FDY-5301 is an experimental medication being tested to see if it can help reduce the risk of death from heart problems and prevent heart failure in patients who have had a specific type of heart attack called an anterior ST-Elevation Myocardial Infarction (STEMI). This medication is given through an intravenous infusion, which means it is administered directly into the bloodstream. The study aims to determine if FDY-5301 can improve outcomes for patients undergoing a procedure called primary percutaneous coronary intervention (pPCI), which is used to open blocked arteries in the heart.

What is already known about the treatment

FDY-5301 – This medication is administered intravenously and is currently being studied in clinical trials for its potential benefits in treating patients with anterior ST-Elevation Myocardial Infarction (STEMI). It is in the experimental phase, with ongoing research to determine its effectiveness in reducing cardiovascular mortality and heart failure events. The main therapeutic indication is for patients experiencing a specific type of heart attack known as anterior STEMI. At the molecular level, FDY-5301 is believed to work by targeting pathways involved in heart muscle protection and repair, although the exact mechanism is still under investigation. It falls under the pharmacological classification of cardiovascular agents.

Investigated diseases

Anterior ST-Elevation Myocardial Infarction – This condition occurs when a major artery supplying blood to the heart is blocked, leading to damage in the front 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 coronary artery. As the heart muscle is deprived of oxygen, it begins to die, which can lead to chest pain, shortness of breath, and other symptoms. If untreated, the damage can extend, affecting the heart's ability to pump blood effectively. Over time, this can lead to complications such as heart failure or arrhythmias.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514372-40-00Protocol codeFDY-5301-302Estimated enrolment2 351 patientsSponsorFaraday Pharmaceuticals Inc.

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