Evaluation in STEMI Patients Using FDY-5301 (NCT04837001) | Clinical Trial Compass
CompletedPhase 3
Evaluation in STEMI Patients Using FDY-5301
United States, Canada, Hungary2,351 participantsStarted 2022-05-02
Plain-language summary
To assess the effect of FDY-5301 on cardiovascular mortality and acute heart failure events in subjects with an anterior STEMI undergoing pPCI.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years
. Anterior STEMI, based on:
. Planned primary PCI to occur ≤ 6 hours of onset of persistent symptoms that caused the patient to pursue medical care for myocardial infarction
. Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved consent obtained for study participation
Exclusion criteria
. Life expectancy of less than 1 year due to non-cardiac pathology
. Known thyroid disease or thyroid disorder, including subjects on thyroid hormone replacement therapy at the time of randomization
. Known allergy to iodine or the excipient of the investigational product (sodium chloride)
. Renal disease requiring dialysis
. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test prior to randomization
. Body weight \> 140 kg (or 309 lbs)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of either cardiovascular mortality or heart failure
. Use of thrombolytic therapy as treatment for the index STEMI event
. Use of investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to randomization or the use of investigational devices within 30 days prior to randomization