Clinical trial NCT04837001: Evaluation in STEMI Patients Using FDY-5301
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Acute Myocardial Infarction
STEMI
Percutaneous Coronary Revascularization
Lead sponsor: Faraday Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-08
Enrollment: 2351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All subjects who fulfill all study eligibility criteria will be randomized and dosed with study drug or placebo.
Primary purpose: TREATMENT

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.

Eligibility 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

   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:

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

Primary outcomes:
measure: Proportion of either cardiovascular mortality or heart failure
timeFrame: Through Month 12
Secondary outcomes:
measure: All-cause mortality or acute heart failure
timeFrame: Through Month 12
measure: Cardiovascular events
timeFrame: Through Month 12
measure: Other non-fatal cardiovascular morbidity
timeFrame: Through Month 12
measure: Serum troponin T
timeFrame: Day 3
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Jacksonville
country: United States
facility: University of Florida Health
state: Florida
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Minneapolis
country: United States
facility: Allina Health System
state: Minnesota
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Newmarket
country: Canada
facility: Southlake Regional Health Center
state: Ontario
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Kórház
city: Budapest
country: Hungary
facility: Gottsegen György Országos Kardiológiai Intézet
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Kórház és Rendelőintézet IV. Belgyógyászat és Kardiológia, Intenzív Coronaria Egység, Haemodinamikai Osztály
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
city: Budapest
country: Hungary
facility: Észak-Pesti Centrumkórház - Honvédkórház
city: Kaposvár
country: Hungary
facility: Somogy Vármegyei Kaposi Mór Oktató Kórház, Kardiológiai Osztály
city: Kecskemét
country: Hungary
facility: Bács-Kiskun Vármegyei Oktatókórház
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház, Nyíregyházi Jósa András Tagkórház
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Kozpönt Szívgyógyászati Klinika
city: Szombathely
country: Hungary
facility: Vas Vármegyei Markusovszky Egyetemi Oktatókórház
city: Székesfehérvár
country: Hungary
facility: Fejér Vármegyei Szent György Egyetemi Oktató Kórház
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Kórház
city: Be'er Ya'aqov
country: Israel
facility: Shamir (Assaf Harofeh) Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center, Beilinson Hospital
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Safed
country: Israel
facility: Ziv Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Białymstoku
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Grodzisk Mazowiecki
country: Poland
facility: Independent Public Specialist Hospital of the West st. John Paul II
city: Kraków
country: Poland
facility: SP ZOZ Szpital Uniwersytecki w Krakowie
city: Krosno
country: Poland
facility: Center for Invasive Cardiology
city: Kutno
country: Poland
facility: Scanmed Centrum Kardiologii Kutno
city: Lublin
country: Poland
facility: Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
city: Toruń
country: Poland
facility: Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
city: Wrocław
country: Poland
facility: 4. Military Clinical Hospital with Polyclinic SP ZOZ
city: Wrocław
country: Poland
facility: Provincial Specialist Hospital in Wrocław
city: Zamość
country: Poland
facility: Independent Public Provincial Hospital
city: Łódź
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej
city: Łódź
country: Poland
facility: Central Clinical Hospital of the Medical University of Łódź
city: Almada
country: Portugal
facility: Hospital Garcia da Orta
state: Setubal
city: Braga
country: Portugal
facility: Hospital de Braga
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário Lisboa Central
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário Lisboa Norte
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário do Porto
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia/Espinho
Study officials:
References: