Evaluation in STEMI Patients Using FDY-5301 (IOCYTE AMI-3)

  • STATUS
    Recruiting
  • End date
    Jul 31, 2024
  • participants needed
    2300
  • sponsor
    Faraday Pharmaceuticals, Inc.
Updated on 6 June 2022

Summary

To assess the effect of FDY-5301 on cardiovascular mortality and acute heart failure events in subjects with an anterior STEMI undergoing pPCI.

Description

The purpose of this study is to evaluate the efficacy and safety of FDY-5301 compared to placebo on cardiovascular clinical outcomes in subjects with an anterior ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI).

The study is designed as a randomized double-blind parallel-group comparison of FDY-5301 and placebo. Inclusion and exclusion criteria have been designed to ensure a broad population including seriously ill patients, with or without prior myocardial infarction or coronary artery bypass graft. Demonstration of efficacy in the anterior STEMI population will translate to all STEMIs agnostic of anatomical location, as the pathophysiology and pharmacology are highly likely to translate from anterior STEMIs to non-anterior STEMIs.

Details
Condition Acute Myocardial Infarction, STEMI, Percutaneous Coronary Revascularization
Treatment Placebo, FDY-5301
Clinical Study IdentifierNCT04837001
SponsorFaraday Pharmaceuticals, Inc.
Last Modified on6 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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 first symptoms of myocardial
ischemia
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
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 or devices 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
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