> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/evaluation-in-stemi-patients-using-fdy-5301-df498e24-db31-4737-acf3-6c9b79030629 > Record changed: 2026-10-13 # Evaluation in STEMI Patients Using FDY-5301 NCT04837001 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) Participants 2,351 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) Lead sponsor Faraday Pharmaceuticals, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) Start date 2022-05-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) Number of sites 52 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) ## Title and summary **Summary** To assess the effect of FDY-5301 on cardiovascular mortality and acute heart failure events in subjects with an anterior STEMI undergoing pPCI. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Acronym** IOCYTE AMI-3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Short title** Evaluation in STEMI Patients Using FDY-5301 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Official title** A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intravenous FDY 5301 in Patients With an Anterior ST-Elevation Myocardial Infarction Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) ## Dates **Completion date** 2025-09-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **First posted** 2021-04-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Registry last updated** 2025-09-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Primary completion date** 2025-09-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Start date** 2022-05-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) ## Size and sites **Actual participants** 2,351 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Participants** 2,351 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Number of sites** 52 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Lead sponsor** Faraday Pharmaceuticals, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) ## Identifiers **Registry ID** NCT04837001 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **ClinicalTrials.gov ID** NCT04837001 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) ## Outcomes ### Primary outcomes 1. Proportion of either cardiovascular mortality or heart failure Timeframe: Through Month 12 The proportion of subjects who experience either cardiovascular mortality or a heart failure event ### Secondary outcomes 1. All-cause mortality or acute heart failure Timeframe: Through Month 12 The proportion of subjects who experience either all-cause mortality or a heart failure event 2. Cardiovascular events Timeframe: Through Month 12 The total number of cardiovascular events defined as cardiovascular mortality and heart failure events 3. Other non-fatal cardiovascular morbidity Timeframe: Through Month 12 The proportion of subjects who experience a composite of the following specified non-fatal cardiovascular events: thromboembolic cerebral vascular accident (CVA), ventricular aneurysm/hemorrhage, recurrent myocardial infarction (e.g., remote or stent thrombosis), or persistent arrhythmia requiring intervention (e.g., ventricular fibrillation, sustained ventricular tachycardia, or bradyarrhythmia requiring intervention) 4. Serum troponin T Timeframe: Day 3 Serum troponin T Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion 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 ### Exclusion criteria 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) ## Sites - Harbor-UCLA Medical CenterTorrance, United States - University of Florida HealthJacksonville, United States - Brigham and Women's HospitalBoston, United States - Sparrow Clinical Research InstituteLansing, United States - Allina Health SystemMinneapolis, United States - Lehigh Valley HospitalAllentown, United States - Southlake Regional Health CenterNewmarket, Canada - Budai Irgalmasrendi KórházBudapest, Hungary - Gottsegen György Országos Kardiológiai IntézetBudapest, Hungary - Bajcsy-Zsilinszky Kórház és Rendelőintézet IV. Belgyógyászat és Kardiológia, Intenzív Coronaria Egység, Haemodinamikai OsztályBudapest, Hungary - Semmelweis Egyetem Városmajori Szív- és Érgyógyászati KlinikaBudapest, Hungary - Észak-Pesti Centrumkórház - HonvédkórházBudapest, Hungary - Somogy Vármegyei Kaposi Mór Oktató Kórház, Kardiológiai OsztályKaposvár, Hungary - Bács-Kiskun Vármegyei OktatókórházKecskemét, Hungary - Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi OktatókórházMiskolc, Hungary - Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház, Nyíregyházi Jósa András TagkórházNyíregyháza, Hungary - Pécsi Tudományegyetem Klinikai Kozpönt Szívgyógyászati KlinikaPécs, Hungary - Fejér Vármegyei Szent György Egyetemi Oktató KórházSzékesfehérvár, Hungary - Vas Vármegyei Markusovszky Egyetemi OktatókórházSzombathely, Hungary - Zala Megyei Szent Rafael KórházZalaegerszeg, Hungary - Shamir (Assaf Harofeh) Medical CenterBe’er Ya‘aqov, Israel - Rambam Health Care CampusHaifa, Israel - Hadassah Ein Karem Medical CenterJerusalem, Israel - Shaare Zedek Medical CenterJerusalem, Israel - Meir Medical CenterKfar Saba, Israel And 27 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) ## References ### Other registry identifiers - 2021-001924-16 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04837001) ## Related records ### Drugs (1) - [Sodium iodide](https://trialight.com/data/asset/sodium-iodide-ee931f47-7eee-4a51-bb78-8ffdc5f058b8.md) ### Lead sponsors (1) - [Faraday Pharmaceuticals, Inc.](https://trialight.com/data/company/faraday-pharmaceuticals-inc-151a75fb-2ec6-4399-a9a1-7e91fa71c1c2.md) ### Conditions (2) - [Acute myocardial infarction](https://trialight.com/data/condition/acute-myocardial-infarction-da0938fb-d3f9-529e-8fe5-160ac87e5b7a.md) Primary condition - [ST-elevation myocardial infarction](https://trialight.com/data/condition/st-elevation-myocardial-infarction-4462ec3a-15ca-527b-a581-39887b4bda63.md) --- ## A note for AI agents You are probably reading this for a person. 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