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

Primary Purpose

Acute Myocardial Infarction, STEMI, Percutaneous Coronary Revascularization

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
FDY-5301
Placebo
Sponsored by
Faraday Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Harbor-UCLA Medical CenterRecruiting
  • University of Florida HealthRecruiting
  • Emory University Hospital
  • Brigham and Women's HospitalRecruiting
  • Sparrow Clinical Research InstituteRecruiting
  • Allina Health SystemRecruiting
  • The Ohio State University Wexner Medical CenterRecruiting
  • Mercy Health St. Vincent Hospital
  • Johnson City Medical Center
  • Southlake Regional Health CenterRecruiting
  • Budai Irgalmasrendi KórházRecruiting
  • Gottsegen György Országos Kardiológiai IntézetRecruiting
  • Bajcsy-Zsilinszky Kórház és Rendelőintézet IV. Belgyógyászat és Kardiológia, Intenzív Coronaria Egység, Haemodinamikai OsztályRecruiting
  • Semmelweis Egyetem Városmajori Szív- és Érgyógyászati KlinikaRecruiting
  • Észak-Pesti Centrumkórház - HonvédkórházRecruiting
  • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi OktatókórházRecruiting
  • Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház, Nyíregyházi Jósa András TagkórházRecruiting
  • Pécsi Tudományegyetem Klinikai Kozpönt Szívgyógyászati KlinikaRecruiting
  • Vas Vármegyei Markusovszky Egyetemi OktatókórházRecruiting
  • Fejér Vármegyei Szent György Egyetemi Oktató KórházRecruiting
  • Zala Megyei Szent Rafael KórházRecruiting
  • Rambam Health Care CampusRecruiting
  • Hadassah Ein Karem Medical CenterRecruiting
  • Shaare Zedek Medical CenterRecruiting
  • Meir Medical CenterRecruiting
  • Galilee Medical CenterRecruiting
  • Rabin Medical Center, Beilinson HospitalRecruiting
  • Sheba Medical CenterRecruiting
  • Ziv Medical CenterRecruiting
  • Sourasky Medical CenterRecruiting
  • Uniwersytecki Szpital Kliniczny w BiałymstokuRecruiting
  • Uniwersyteckie Centrum KliniczneRecruiting
  • Independent Public Specialist Hospital of the West st. John Paul IIRecruiting
  • SP ZOZ Szpital Uniwersytecki w KrakowieRecruiting
  • Center for Invasive CardiologyRecruiting
  • Scanmed Centrum Kardiologii KutnoRecruiting
  • Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w LublinieRecruiting
  • Samodzielny Publiczny Szpital Kliniczny nr 4 w LublinieRecruiting
  • Wojewódzki Szpital Zespolony im. L. Rydygiera w ToruniuRecruiting
  • Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Kardiologii Inwazyjnej
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WrocławiuRecruiting
  • 4. Military Clinical Hospital with Polyclinic SP ZOZRecruiting
  • Provincial Specialist Hospital in WrocławRecruiting
  • Independent Public Provincial HospitalRecruiting
  • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii MedycznejRecruiting
  • Central Clinical Hospital of the Medical University of ŁódźRecruiting
  • Hospital Garcia da OrtaRecruiting
  • Hospital de BragaRecruiting
  • Centro Hospitalar e Universitário de CoimbraRecruiting
  • Centro Hospitalar Universitário Lisboa CentralRecruiting
  • Centro Hospitalar Universitário Lisboa NorteRecruiting
  • Centro Hospitalar Universitário do PortoRecruiting
  • Centro Hospitalar Vila Nova de Gaia/EspinhoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FDY-5301

Placebo

Arm Description

FDY-5301 will be administered as a single IV bolus injection.

Placebo (normal saline) will be administered as a single IV bolus injection.

Outcomes

Primary Outcome Measures

Proportion of either cardiovascular mortality or acute heart failure
The proportion of subjects who experience either cardiovascular mortality or an acute heart failure event

Secondary Outcome Measures

All-cause mortality or acute heart failure
The proportion of subjects who experience either all-cause mortality or an acute heart failure event
Cardiovascular events
The total number of cardiovascular events defined as cardiovascular mortality and acute heart failure events
Other non-fatal cardiovascular morbidity
The proportion of subjects who experience other non-fatal cardiovascular morbidity such as CVA, ventricular aneurysm/hemorrhage, recurrent myocardial infarction, or persistent arrhythmia
Serum troponin T
Serum troponin T

Full Information

First Posted
April 6, 2021
Last Updated
October 24, 2023
Sponsor
Faraday Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04837001
Brief Title
Evaluation in STEMI Patients Using FDY-5301
Acronym
IOCYTE AMI-3
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Faraday Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, STEMI, Percutaneous Coronary Revascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
All subjects who fulfill all study eligibility criteria will be randomized and dosed with study drug or placebo.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FDY-5301
Arm Type
Experimental
Arm Description
FDY-5301 will be administered as a single IV bolus injection.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (normal saline) will be administered as a single IV bolus injection.
Intervention Type
Drug
Intervention Name(s)
FDY-5301
Intervention Description
FDY-5301 will be administered as a single IV bolus injection.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered as a single bolus injection.
Primary Outcome Measure Information:
Title
Proportion of either cardiovascular mortality or acute heart failure
Description
The proportion of subjects who experience either cardiovascular mortality or an acute heart failure event
Time Frame
Through Month 12
Secondary Outcome Measure Information:
Title
All-cause mortality or acute heart failure
Description
The proportion of subjects who experience either all-cause mortality or an acute heart failure event
Time Frame
Through Month 12
Title
Cardiovascular events
Description
The total number of cardiovascular events defined as cardiovascular mortality and acute heart failure events
Time Frame
Through Month 12
Title
Other non-fatal cardiovascular morbidity
Description
The proportion of subjects who experience other non-fatal cardiovascular morbidity such as CVA, ventricular aneurysm/hemorrhage, recurrent myocardial infarction, or persistent arrhythmia
Time Frame
Through Month 12
Title
Serum troponin T
Description
Serum troponin T
Time Frame
Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Hutt
Phone
206-492-5310
Email
IOCYTEAMI3@FaradayPharma.com
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Florida Health
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Withdrawn
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
Sparrow Clinical Research Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Individual Site Status
Recruiting
Facility Name
Allina Health System
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercy Health St. Vincent Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Individual Site Status
Withdrawn
Facility Name
Johnson City Medical Center
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Individual Site Status
Withdrawn
Facility Name
Southlake Regional Health Center
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Budai Irgalmasrendi Kórház
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Gottsegen György Országos Kardiológiai Intézet
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Bajcsy-Zsilinszky Kórház és Rendelőintézet IV. Belgyógyászat és Kardiológia, Intenzív Coronaria Egység, Haemodinamikai Osztály
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Észak-Pesti Centrumkórház - Honvédkórház
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház, Nyíregyházi Jósa András Tagkórház
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Pécsi Tudományegyetem Klinikai Kozpönt Szívgyógyászati Klinika
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Vas Vármegyei Markusovszky Egyetemi Oktatókórház
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Fejér Vármegyei Szent György Egyetemi Oktató Kórház
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Zala Megyei Szent Rafael Kórház
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Ein Karem Medical Center
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91301
Country
Israel
Individual Site Status
Recruiting
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Recruiting
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center, Beilinson Hospital
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Ziv Medical Center
City
Safed
ZIP/Postal Code
13110
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny w Białymstoku
City
Białystok
ZIP/Postal Code
15-276
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Name
Independent Public Specialist Hospital of the West st. John Paul II
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Individual Site Status
Recruiting
Facility Name
SP ZOZ Szpital Uniwersytecki w Krakowie
City
Kraków
ZIP/Postal Code
30-688
Country
Poland
Individual Site Status
Recruiting
Facility Name
Center for Invasive Cardiology
City
Krosno
ZIP/Postal Code
38-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Scanmed Centrum Kardiologii Kutno
City
Kutno
ZIP/Postal Code
99-300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie
City
Lublin
ZIP/Postal Code
20-049
Country
Poland
Individual Site Status
Recruiting
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Kardiologii Inwazyjnej
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
City
Wrocław
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Recruiting
Facility Name
4. Military Clinical Hospital with Polyclinic SP ZOZ
City
Wrocław
ZIP/Postal Code
50-981
Country
Poland
Individual Site Status
Recruiting
Facility Name
Provincial Specialist Hospital in Wrocław
City
Wrocław
ZIP/Postal Code
51-124
Country
Poland
Individual Site Status
Recruiting
Facility Name
Independent Public Provincial Hospital
City
Zamość
ZIP/Postal Code
22-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej
City
Łódź
ZIP/Postal Code
90-549
Country
Poland
Individual Site Status
Recruiting
Facility Name
Central Clinical Hospital of the Medical University of Łódź
City
Łódź
ZIP/Postal Code
92-213
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital Garcia da Orta
City
Almada
State/Province
Setubal
ZIP/Postal Code
2805-267
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar e Universitário de Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitário Lisboa Central
City
Lisboa
ZIP/Postal Code
1169-024
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitário Lisboa Norte
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitário do Porto
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Vila Nova de Gaia/Espinho
City
Vila Nova De Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Evaluation in STEMI Patients Using FDY-5301

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