Evaluation in STEMI Patients Using FDY-5301
Completed · Phase 3 · Has a placebo group
Conditions studied: Acute Myocardial Infarction, STEMI, Percutaneous Coronary Revascularization
In brief
To assess the effect of FDY-5301 on cardiovascular mortality and acute heart failure events in subjects with an anterior STEMI undergoing pPCI.
Key facts
- Study ID
- NCT04837001
- Run by
- Faraday Pharmaceuticals, Inc.
- People needed
- 2351
- Starts
- 2022-05-02
- Expected to finish
- 2025-09-03
- Last updated by the study team
- 2025-09-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- 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
- 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
You may not qualify if…
- 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)
- 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
- 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
Where it is running
- University of Florida Health — Jacksonville, Florida, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Sparrow Clinical Research Institute — Lansing, Michigan, United States
- Allina Health System — Minneapolis, Minnesota, United States
- Lehigh Valley Hospital — Allentown, Pennsylvania, United States
- Southlake Regional Health Center — Newmarket, Ontario, Canada
- Budai Irgalmasrendi Kórház — Budapest, Hungary
- Gottsegen György Országos Kardiológiai Intézet — Budapest, Hungary
- Bajcsy-Zsilinszky Kórház és Rendelőintézet IV. Belgyógyászat és Kardiológia, Intenzív Coronaria Egység, Haemodinamikai Osztály — Budapest, Hungary
- Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika — Budapest, Hungary
- Észak-Pesti Centrumkórház - Honvédkórház — Budapest, Hungary
- Somogy Vármegyei Kaposi Mór Oktató Kórház, Kardiológiai Osztály — Kaposvár, Hungary
- Bács-Kiskun Vármegyei Oktatókórház — Kecskemét, Hungary
- Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház — Miskolc, Hungary
- Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház, Nyíregyházi Jósa András Tagkórház — Nyíregyháza, Hungary
- Pécsi Tudományegyetem Klinikai Kozpönt Szívgyógyászati Klinika — Pécs, Hungary
- Fejér Vármegyei Szent György Egyetemi Oktató Kórház — Székesfehérvár, Hungary
- Vas Vármegyei Markusovszky Egyetemi Oktatókórház — Szombathely, Hungary
- Zala Megyei Szent Rafael Kórház — Zalaegerszeg, Hungary
- Shamir (Assaf Harofeh) Medical Center — Be’er Ya‘aqov, Israel
- Rambam Health Care Campus — Haifa, Israel
- Hadassah Ein Karem Medical Center — Jerusalem, Israel
- Shaare Zedek Medical Center — Jerusalem, Israel
- Meir Medical Center — Kfar Saba, Israel
- Harbor-UCLA Medical Center — Torrance, California, United States
Full record on ClinicalTrials.gov
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