Status:
COMPLETED
Evaluation in STEMI Patients Using FDY-5301
Lead Sponsor:
Faraday Pharmaceuticals, Inc.
Conditions:
Acute Myocardial Infarction
STEMI
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To assess the effect of FDY-5301 on cardiovascular mortality and acute heart failure events in subjects with an anterior STEMI undergoing pPCI.
Detailed 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 (ST...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2025
Estimated Enrollment :
2351 Patients enrolled
Trial Details
Trial ID
NCT04837001
Start Date
May 2 2022
End Date
September 3 2025
Last Update
September 12 2025
Active Locations (52)
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1
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
2
University of Florida Health
Jacksonville, Florida, United States, 32209
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
4
Sparrow Clinical Research Institute
Lansing, Michigan, United States, 48912