IOCYTE AMI-3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intravenous FDY-5301 in Patients with an Anterior ST-Elevation Myocardial Infarction
This research study, called IOCYTE AMI-3, is looking at a new medicine, FDY-5301, for patients who have recently had a specific type of serious heart attack known as an anterior ST-elevation myocardial infarction. This is a "Phase 3" trial, meaning it's a large study to confirm if the medicine works and is safe. Some patients will receive the new medicine through a drip, while others will get a placebo (a dummy treatment that looks the same) to allow for a fair comparison. The main goal is to find out if FDY-5301 can reduce the number of serious heart-related events, such as further heart problems or death, within 12 months after the heart attack. Researchers are also looking at other important measures of heart health.
At a glance
What is this study about?
You're reading about a medical research study called IOCYTE AMI-3. This study is for people who have recently experienced a particular kind of severe heart attack, specifically an "anterior ST-elevation myocardial infarction" – often shortened to STEMI. This type of heart attack happens when a major blood vessel supplying the front part of your heart is completely blocked, causing damage to the heart muscle.
The study is investigating a new medication called FDY-5301, which is given through a drip (intravenously). The main aim is to see if this new medicine can help improve outcomes for patients after such a heart attack. Researchers want to know if it can lower the chance of serious health problems or even death related to the heart within a year of the heart attack. This is important because even after initial treatment for a heart attack, some people can still face long-term challenges.
To make sure the results are fair and reliable, this study is "randomised" and "double-blind." This means that some patients will be randomly chosen to receive the new medicine, while others will receive a 'placebo' – a dummy liquid that looks and feels exactly like the study medicine but contains no active drug. Neither you nor your doctor will know which treatment you are receiving. This helps researchers accurately see if any improvements are due to the new medicine itself, rather than other factors.
Key takeaways
- A study testing a new medicine (FDY-5301) for a specific type of severe heart attack.
- Compares the new medicine to a 'dummy' treatment (placebo) to see if it helps.
- Aims to reduce serious heart problems or death over 12 months after a heart attack.
- Open to adults aged 18 and over, both men and women.
- Participants will receive close medical monitoring throughout the one-year study.
Who may be eligible?
This study is looking for both men and women to take part. To be eligible, you must be at least 18 years old. There is no upper age limit for joining.
Beyond your age and sex, specific medical details about your heart attack and your current health will also be carefully checked by the study doctors. For example, they'll need to confirm that you've had the specific type of heart attack (anterior ST-elevation myocardial infarction) that the study is focusing on.
It's important to remember that even if you meet these general criteria, there might be other medical reasons mentioned in the study's full eligibility rules that could mean you aren't able to join. These specific details would be discussed with you by the research team if you show interest in participating.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you recently had a severe heart attack? (Anterior ST-elevation myocardial infarction)
- Are you able to attend regular check-ups and visits for a year?
- Are you willing to potentially receive either the new medicine or a placebo?
What does participation involve?
If you decide to take part in this study, you would receive the study medicine (FDY-5301) or the placebo through an intravenous drip. You wouldn't know which one you're receiving. After this, you would have regular check-ups and assessments to monitor your health and how the treatment might be affecting you. These would involve clinic visits, and possibly blood tests or other heart-related tests. The researchers would be particularly interested in your health outcomes for up to 12 months (one year) after your initial treatment, focusing on preventing future heart problems or complications. The total duration of your participation in the study, including all follow-up, would be 12 months.
Potential risks and benefits
Locations (9)
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- —UnverifiedGermany
- —UnverifiedPoland
- —UnverifiedItaly
Common questions
What is FDY-5301?
It's a new medicine being tested to see if it can help people who have had a very specific type of severe heart attack.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks exactly like the real medicine but contains no active drug. It helps compare the new medicine fairly.
How long does the study last?
If you join, the study will involve following your health for 12 months (one year) after your heart attack.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your doctors will know. This is to ensure the study results are as accurate as possible.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any point, and your decision will not affect your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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