Evaluation in STEMI Patients Using FDY-5301
- Conditions
- STEMIPercutaneous Coronary RevascularizationAcute Myocardial Infarction
- Interventions
- Other: Placebo
- Registration Number
- NCT04837001
- Lead Sponsor
- Faraday Pharmaceuticals, Inc.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2351
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FDY-5301 FDY-5301 FDY-5301 will be administered as a single IV bolus injection. Placebo Placebo Placebo (normal saline) will be administered as a single IV bolus injection.
- Primary Outcome Measures
Name Time Method Proportion of either cardiovascular mortality or heart failure Through Month 12 The proportion of subjects who experience either cardiovascular mortality or a heart failure event
- Secondary Outcome Measures
Name Time Method All-cause mortality or acute heart failure Through Month 12 The proportion of subjects who experience either all-cause mortality or a heart failure event
Cardiovascular events Through Month 12 The total number of cardiovascular events defined as cardiovascular mortality and heart failure events
Other non-fatal cardiovascular morbidity Through Month 12 The proportion of subjects who experience a composite of the following specified non-fatal cardiovascular events: thromboembolic cerebral vascular accident (CVA), ventricular aneurysm/hemorrhage, recurrent myocardial infarction (e.g., remote or stent thrombosis), or persistent arrhythmia requiring intervention (e.g., ventricular fibrillation, sustained ventricular tachycardia, or bradyarrhythmia requiring intervention)
Serum troponin T Day 3 Serum troponin T
Trial Locations
- Locations (52)
Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Allina Health System
🇺🇸Minneapolis, Minnesota, United States
Észak-Pesti Centrumkórház - Honvédkórház
🇭🇺Budapest, Hungary
Somogy Vármegyei Kaposi Mór Oktató Kórház, Kardiológiai Osztály
🇭🇺Kaposvár, Hungary
Pécsi Tudományegyetem Klinikai Kozpönt Szívgyógyászati Klinika
🇭🇺Pécs, Hungary
Scanmed Centrum Kardiologii Kutno
🇵🇱Kutno, Poland
4. Military Clinical Hospital with Polyclinic SP ZOZ
🇵🇱Wrocław, Poland
Centro Hospitalar e Universitário de Coimbra
🇵🇹Coimbra, Portugal
University of Florida Health
🇺🇸Jacksonville, Florida, United States
Southlake Regional Health Center
🇨🇦Newmarket, Ontario, Canada
Rambam Health Care Campus
🇮🇱Haifa, Israel
Galilee Medical Center
🇮🇱Nahariya, Israel
Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu
🇵🇱Toruń, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
🇵🇱Wrocław, Poland
Independent Public Specialist Hospital of the West st. John Paul II
🇵🇱Grodzisk Mazowiecki, Poland
Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie
🇵🇱Lublin, Poland
Hospital de Braga
🇵🇹Braga, Portugal
Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej
🇵🇱Łódź, Poland
Central Clinical Hospital of the Medical University of Łódź
🇵🇱Łódź, Poland
Hospital Garcia da Orta
🇵🇹Almada, Setubal, Portugal
Centro Hospitalar Universitário Lisboa Central
🇵🇹Lisboa, Portugal
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Sparrow Clinical Research Institute
🇺🇸Lansing, Michigan, United States
Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
🇭🇺Budapest, Hungary
Hadassah Ein Karem Medical Center
🇮🇱Jerusalem, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Centro Hospitalar Vila Nova de Gaia/Espinho
🇵🇹Vila Nova De Gaia, Portugal
SP ZOZ Szpital Uniwersytecki w Krakowie
🇵🇱Kraków, Poland
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
Budai Irgalmasrendi Kórház
🇭🇺Budapest, Hungary
Vas Vármegyei Markusovszky Egyetemi Oktatókórház
🇭🇺Szombathely, Hungary
Zala Megyei Szent Rafael Kórház
🇭🇺Zalaegerszeg, Hungary
Ziv Medical Center
🇮🇱Safed, Israel
Center for Invasive Cardiology
🇵🇱Krosno, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
🇵🇱Lublin, Poland
Provincial Specialist Hospital in Wrocław
🇵🇱Wrocław, Poland
Bajcsy-Zsilinszky Kórház és Rendelőintézet IV. Belgyógyászat és Kardiológia, Intenzív Coronaria Egység, Haemodinamikai Osztály
🇭🇺Budapest, Hungary
Gottsegen György Országos Kardiológiai Intézet
🇭🇺Budapest, Hungary
Fejér Vármegyei Szent György Egyetemi Oktató Kórház
🇭🇺Székesfehérvár, Hungary
Uniwersytecki Szpital Kliniczny w Białymstoku
🇵🇱Białystok, Poland
Centro Hospitalar Universitário do Porto
🇵🇹Porto, Portugal
Shamir (Assaf Harofeh) Medical Center
🇮🇱Be'er Ya'aqov, Israel
Rabin Medical Center, Beilinson Hospital
🇮🇱Petach Tikva, Israel
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdańsk, Poland
Independent Public Provincial Hospital
🇵🇱Zamość, Poland
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Centro Hospitalar Universitário Lisboa Norte
🇵🇹Lisboa, Portugal