Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2351 participants
INTERVENTIONAL
2022-05-02
2025-09-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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FDY-5301
FDY-5301 will be administered as a single IV bolus injection.
FDY-5301
FDY-5301 will be administered as a single IV bolus injection.
Placebo
Placebo (normal saline) will be administered as a single IV bolus injection.
Placebo
Placebo will be administered as a single bolus injection.
Interventions
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FDY-5301
FDY-5301 will be administered as a single IV bolus injection.
Placebo
Placebo will be administered as a single bolus injection.
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Faraday Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Harbor-UCLA Medical Center
Torrance, California, United States
University of Florida Health
Jacksonville, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
Allina Health System
Minneapolis, Minnesota, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Southlake Regional Health Center
Newmarket, Ontario, Canada
Budai Irgalmasrendi Kórház
Budapest, , Hungary
Gottsegen György Országos Kardiológiai Intézet
Budapest, , Hungary
Bajcsy-Zsilinszky Kórház és Rendelőintézet IV. Belgyógyászat és Kardiológia, Intenzív Coronaria Egység, Haemodinamikai Osztály
Budapest, , Hungary
Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
Budapest, , Hungary
Észak-Pesti Centrumkórház - Honvédkórház
Budapest, , Hungary
Somogy Vármegyei Kaposi Mór Oktató Kórház, Kardiológiai Osztály
Kaposvár, , Hungary
Bács-Kiskun Vármegyei Oktatókórház
Kecskemét, , Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
Miskolc, , Hungary
Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház, Nyíregyházi Jósa András Tagkórház
Nyíregyháza, , Hungary
Pécsi Tudományegyetem Klinikai Kozpönt Szívgyógyászati Klinika
Pécs, , Hungary
Fejér Vármegyei Szent György Egyetemi Oktató Kórház
Székesfehérvár, , Hungary
Vas Vármegyei Markusovszky Egyetemi Oktatókórház
Szombathely, , Hungary
Zala Megyei Szent Rafael Kórház
Zalaegerszeg, , Hungary
Shamir (Assaf Harofeh) Medical Center
Be’er Ya‘aqov, , Israel
Rambam Health Care Campus
Haifa, , Israel
Hadassah Ein Karem Medical Center
Jerusalem, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Galilee Medical Center
Nahariya, , Israel
Rabin Medical Center, Beilinson Hospital
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Ziv Medical Center
Safed, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Independent Public Specialist Hospital of the West st. John Paul II
Grodzisk Mazowiecki, , Poland
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Center for Invasive Cardiology
Krosno, , Poland
Scanmed Centrum Kardiologii Kutno
Kutno, , Poland
Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej
Lodz, , Poland
Central Clinical Hospital of the Medical University of Łódź
Lodz, , Poland
Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie
Lublin, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, , Poland
Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu
Torun, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, , Poland
4. Military Clinical Hospital with Polyclinic SP ZOZ
Wroclaw, , Poland
Provincial Specialist Hospital in Wrocław
Wroclaw, , Poland
Independent Public Provincial Hospital
Zamość, , Poland
Hospital Garcia da Orta
Almada, Setúbal District, Portugal
Hospital de Braga
Braga, , Portugal
Centro Hospitalar e Universitário de Coimbra
Coimbra, , Portugal
Centro Hospitalar Universitário Lisboa Central
Lisbon, , Portugal
Centro Hospitalar Universitário Lisboa Norte
Lisbon, , Portugal
Centro Hospitalar Universitário do Porto
Porto, , Portugal
Centro Hospitalar Vila Nova de Gaia/Espinho
Vila Nova de Gaia, , Portugal
Countries
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Other Identifiers
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2021-001924-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FDY-5301-302
Identifier Type: -
Identifier Source: org_study_id
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