We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04837001
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04837001
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 14, 2023
Sponsor:
Information provided by (Responsible Party):
Faraday Pharmaceuticals, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction STEMI Percutaneous Coronary Revascularization Drug: FDY-5301 Other: Placebo Phase 3

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 (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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All subjects who fulfill all study eligibility criteria will be randomized and dosed with study drug or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2, 2022
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: FDY-5301
FDY-5301 will be administered as a single IV bolus injection.
 Drug: FDY-5301
FDY-5301 will be administered as a single IV bolus injection.
Placebo Comparator: Placebo
Placebo (normal saline) will be administered as a single IV bolus injection.
 Other: Placebo
Placebo will be administered as a single bolus injection.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Proportion of either cardiovascular mortality or acute heart failure [ Time Frame: Through Month 12 ]
    The proportion of subjects who experience either cardiovascular mortality or an acute heart failure event


Secondary Outcome Measures :
  1. All-cause mortality or acute heart failure [ Time Frame: Through Month 12 ]
    The proportion of subjects who experience either all-cause mortality or an acute heart failure event

  2. Cardiovascular events [ Time Frame: Through Month 12 ]
    The total number of cardiovascular events defined as cardiovascular mortality and acute heart failure events

  3. Other non-fatal cardiovascular morbidity [ Time Frame: Through Month 12 ]
    The proportion of subjects who experience other non-fatal cardiovascular morbidity such as CVA, ventricular aneurysm/hemorrhage, recurrent myocardial infarction, or persistent arrhythmia

  4. Serum troponin T [ Time Frame: Day 3 ]
    Serum troponin T


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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

    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 first symptoms of myocardial ischemia
  4. Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved consent obtained for study participation

Exclusion Criteria:

  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
  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 or devices 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04837001


Contacts
Layout table for location contacts
Contact: Catherine Hutt 206-492-5310 IOCYTEAMI3@FaradayPharma.com

Locations
Show Show 49 study locations
Sponsors and Collaborators
Faraday Pharmaceuticals, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Faraday Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04837001    
Other Study ID Numbers: FDY-5301-302
2021-001924-16 ( EudraCT Number )
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 14, 2023
Last Verified: April 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases