Evaluation in STEMI Patients Using FDY-5301

NCT04837001
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Phase
Phase 3
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Recruitment status
Completed
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Participants
2,351
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Lead sponsor
Faraday Pharmaceuticals, Inc.
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Start date
2022-05-02
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Number of sites
52
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Summary
To assess the effect of FDY-5301 on cardiovascular mortality and acute heart failure events in subjects with an anterior STEMI undergoing pPCI.
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Acronym
IOCYTE AMI-3
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Short title
Evaluation in STEMI Patients Using FDY-5301
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2025-09-03
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First posted
2021-04-08
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Registry last updated
2025-09-12
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Primary completion date
2025-09-03
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Start date
2022-05-02
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Actual participants
2,351
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Participants
2,351
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
52
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Faraday Pharmaceuticals, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT04837001
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ClinicalTrials.gov ID
NCT04837001
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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

  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
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  • 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
clinicaltrials.gov

Other registry identifiers

  • 2021-001924-16
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)