Related Experiment Video
Updated: Oct 13, 2025
Author Spotlight: Methodologies and Advancements of Chronic Pain Management Research
Published on: January 5, 2024
A Randomized, double-blind, dose ranging clinical trial of intravenous FDY-5301 in acute STEMI patients undergoing
David Adlam1, Maciej Zarebinski2, Neal G Uren3
1Department of Cardiovascular Sciences, NIHR Leicester Biomedical Research Centre, University of Leicester, UK.
Insights
FDY-5301, a novel treatment, shows promise in reducing heart damage from ischemia-reperfusion injury in ST-elevation myocardial infarction (STEMI) patients. This study found the treatment feasible and safe, warranting further investigation.
Area of Science:
- Cardiology
- Pharmacology
- Biochemistry
Background:
- Ischemia-reperfusion injury (IRI) is a significant clinical challenge in ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PPCI).
- Current treatments lack efficacy in mitigating myocardial damage caused by rapid reoxygenation and reactive oxygen species (ROS) during reperfusion.
- FDY-5301, containing sodium iodide, acts as a catalytic anti-peroxidant, offering a potential therapeutic strategy against IRI.
Purpose of the Study:
- To evaluate the feasibility, safety, and potential utility of FDY-5301 in limiting ischemia-reperfusion injury in STEMI patients undergoing emergency PPCI.
- To assess the impact of FDY-5301 on cardiac arrhythmias and infarct size.
- To explore the effects of FDY-5301 on specific biomarkers related to myocardial injury and inflammation.
Main Methods:
- A double-blind, randomized Phase 2 clinical trial involving 120 STEMI patients undergoing PPCI.
- Patients received varying doses of FDY-5301 or placebo intravenously prior to reperfusion.
- Endpoints included feasibility, cardiac arrhythmia monitoring for 14 days, and cardiac MRI at 72 hours and 3 months to assess infarct size and left ventricular ejection fraction.
Main Results:
- Intravenous FDY-5301 was safely administered to 97% of participants before reperfusion, rapidly increasing plasma iodide levels.
- No significant increase in cardiac arrhythmias of concern was observed.
- Three-month MRI showed a trend towards smaller infarct sizes (8.5% vs. 14.9%) and improved ejection fractions (63.2% vs. 53.9%) in the highest FDY-5301 dose group compared to placebo.
- FDY-5301 treatment correlated with reduced levels of MPO, MMP2, and NTproBNP post-PPCI.
Conclusions:
- Intravenous FDY-5301 is a feasible and safe adjunctive therapy for acute STEMI patients undergoing PPCI.
- The study suggests potential efficacy of FDY-5301 in reducing ischemia-reperfusion injury.
- A larger clinical trial is warranted to confirm these findings and evaluate the impact on clinical outcomes.
Background:
Ischemia-reperfusion injury remains a major clinical problem in patients with ST-elevation myocardial infarction (STEMI), leading to myocardial damage despite early reperfusion by primary percutaneous coronary intervention (PPCI). There are no effective therapies to limit ischemia-reperfusion injury, which is caused by multiple pathways activated by rapid tissue reoxygenation and the generation of reactive oxygen species (ROS). FDY-5301 contains sodium iodide, a ubiquitous inorganic halide and elemental reducing agent that can act as a catalytic anti-peroxidant. We tested the feasibility, safety and potential utility of FDY-5301 as a treatment to limit ischemia-reperfusion injury, in patients with first-time STEMI undergoing emergency PPCI.
Methods:
STEMI patients (n = 120, median 62 years) presenting within 12 h of chest pain onset were randomized at 20 PPCI centers, in a double blind Phase 2 clinical trial, to receive FDY-5301 (0.5, 1.0 or 2.0 mg/kg) or placebo prior to reperfusion, to evaluate the feasibility endpoints. Participants underwent continuous ECG monitoring for 14 days after PPCI to address pre-specified cardiac arrhythmia safety end points and cardiac magnetic resonance imaging (MRI) at 72 h and at 3 months to assess exploratory efficacy end points.
Results:
Intravenous FDY-5301 was delivered before re-opening of the infarct-related artery in 97% participants and increased plasma iodide levels ~1000-fold within 2 min. There was no significant increase in the primary safety end point of incidence of cardiac arrhythmias of concern. MRI at 3 months revealed median final infarct sizes in placebo vs. 2.0 mg/kg FDY-5301-treated patients of 14.9% vs. 8.5%, and LV ejection fractions of 53.9% vs. 63.2%, respectively, although the study was not powered to detect statistical significance. In patients receiving FDY-5301, there was a significant reduction in the levels of MPO, MMP2 and NTproBNP after PPCI, but no reduction with placebo.
Conclusions:
Intravenous FDY-5301, delivered immediately prior to PPCI in acute STEMI, is feasible, safe, and shows potential efficacy. A larger trial is justified to test the effects of FDY-5301 on acute ischemia-reperfusion injury and clinical outcomes.
Clinical Trial Registration:
CT.govNCT03470441; EudraCT 2017-000047-41.
More Related Videos
10:28Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
Published on: March 15, 2022
08:53Randomized, Triple-Blind, and Parallel-Controlled Trial of Transcranial Direct Current Stimulation for Cognitive Rehabilitation after Stroke
Published on: June 6, 2025
Related Concept Videos
01:30Acute Coronary Syndrome III: Diagnostic Studies
01:28Acute Coronary Syndrome IV: Interprofessional Care
01:30Acute Coronary Syndrome I: Introduction