BridgeMD
A Phase 3, randomized, double-blind, placebo-controlled, multicenter study of IV FDY-5301 in patients with a myocardial infarction (STEMI)
EU CTIS ID: 2024-514372-40-00
What this study is testing
To assess the effect of FDY-5301 on cardiovascular mortality and heart failure events in subjects with an anterior STEMI undergoing pPCI.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age ≥ 18 years
- 2. Anterior STEMI, based on: Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) and Electrocardiogram (ECG) criteria: • men > 40 years: ≥ 2 mm of ST elevation in V2 and V3 • men ≤ 40 years: ≥ 2.5 mm of ST elevation in V2 and V3 • women: ≥ 1.5 mm of ST elevation in V2 and V3
- 3. Planned primary PCI to occur ≤ 6 hours of onset of persistent symptoms that caused the patient to pursue medical care for myocardial infarction
- 4. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent obtained for study participation
You likely can't join if
- 1. Life expectancy of less than 1 year due to non-cardiac pathology
- 2. Known thyroid disease or thyroid disorder, including subjects on thyroid hormone replacement therapy at the time of randomization
- 3. Known allergy to iodine or the excipient of the investigational product (sodium chloride)
- 4. Renal disease requiring dialysis
- 5. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test prior to randomization
- 6. Body weight > 140 kg (or 309 lbs)
See the full eligibility criteria
- 1. Age ≥ 18 years
- 2. Anterior STEMI, based on: Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) and Electrocardiogram (ECG) criteria: • men > 40 years: ≥ 2 mm of ST elevation in V2 and V3 • men ≤ 40 years: ≥ 2.5 mm of ST elevation in V2 and V3 • women: ≥ 1.5 mm of ST elevation in V2 and V3
- 3. Planned primary PCI to occur ≤ 6 hours of onset of persistent symptoms that caused the patient to pursue medical care for myocardial infarction
- 4. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent obtained for study participation
- 1. Life expectancy of less than 1 year due to non-cardiac pathology
- 2. Known thyroid disease or thyroid disorder, including subjects on thyroid hormone replacement therapy at the time of randomization
- 3. Known allergy to iodine or the excipient of the investigational product (sodium chloride)
- 4. Renal disease requiring dialysis
- 5. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test prior to randomization
- 6. Body weight > 140 kg (or 309 lbs)
- 7. Use of thrombolytic therapy as treatment for the index STEMI event
- 8. 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
- 9. Any clinically significant abnormality identified prior to randomization that in the judgment of the Investigator or Sponsor would preclude safe completion of the study, or confound the anticipated benefit of FDY-5301
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
- United States
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United Kingdom; United States; Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.