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.
1joining 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.
2initial 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.
3monitoring 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.
4completion 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 Study?
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)</b), a test that checks the heart's electrical activity. For men over 40, the ECG must show at least 2 mm of ST elevation in specific heart leads. For men 40 or younger, it must show at least 2.5 mm. For women, it must show at least 1.5 mm.
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 Study?
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.
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.
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.
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