CompletedPhase 3

Evaluation in STEMI Patients Using FDY-5301

United States2,351 participantsStarted 2022-05-02

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18 years
✓. Anterior STEMI, based on:
✓. 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

✕. 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

Proportion of either cardiovascular mortality or heart failure

Timeframe: Through Month 12

NCT IDNCT04837001

SponsorFaraday Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-03