Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of three dose levels of FDY-5301 compared to placebo in STEMI patients undergoing PCI.


Clinical Trial Description

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called FDY-5301 as a possible treatment to reduce the size of the injury to the heart caused by the heart attack. An experimental drug is one that is being tested and is not approved by the United States Food and Drug Administration (FDA). A heart attack occurs when a heart (coronary) artery supplying blood to the heart muscle becomes blocked and the heart muscle is injured. You will be having a cardiac catheterization procedure to clear the blockage in your coronary artery that caused your heart attack. This procedure works well but may not completely prevent some injury to the heart muscle which occurs when the blood supply is initially restored to the heart. This is known as "reperfusion injury". FDY-5301 is a single intravenous injection. About 80 subjects are expected to participate in this study at about 20 research sites in the United States and Europe. Each subject's participation is expected to last about 6 months after receiving the study drug. Subjects who meet all inclusion criteria will be randomly assigned to one of 4 study groups. Three groups will receive FDY-5301 (low, intermediate, or high dose) and 1 group will receive a placebo.The study drug (FDY-5301 or placebo) will be given through a vein (intravenously) during the catheterization procedure. This is a double-blind study so neither the patient nor study personnel will know whether the dose is active drug or placebo until the end of the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03470441
Study type Interventional
Source Faraday Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 2
Start date October 27, 2017
Completion date January 3, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT04451967 - Acute Myocardial Infarction Study in Northeastern China
Completed NCT05974397 - Nationwide Trends in Incidence, Healthcare Utilization, and Mortality in Hospitalized Acute Myocardial Infarction Patients in Taiwan
Not yet recruiting NCT04072081 - Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions N/A
Recruiting NCT03940443 - Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
Recruiting NCT03707626 - Collateral Circulation to LAD and Wellens Sign
Completed NCT02669810 - EXCELLENT (EXpanded CELL ENdocardiac Transplantation) Phase 2
Not yet recruiting NCT04104048 - Short Term Outcome of Primary Precutaneous Coronary Intervention in Ostial Versus Non Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infraction
Active, not recruiting NCT02915107 - The SORT OUT IX STEMI OCT Trial N/A
Completed NCT02896543 - The Relationship of Change of Dendritic Cells Fractalkine and P-selectin Patients With Acute Myocardial Infarction N/A
Completed NCT02490969 - Copeptin Registry (proCORE) Biomarkers in Cardiology (BIC)-19 N/A
Completed NCT02531165 - Platelet Inhibition After Pre-hospital Ticagrelor Using Fentanyl Compared to Morphine in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention N/A
Withdrawn NCT01901471 - Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock Phase 2
Completed NCT02312336 - A Pilot Study of Transcoronary Myocardial Cooling N/A
Recruiting NCT02071342 - Study of ABSORB Stent in Acute Myocardial Infarction N/A
Completed NCT02070913 - COOL-AMI EU Case Series Clinical Study
Terminated NCT01972126 - MAGNetic QRS-Fragmentation in Patients With Myocardial InfarcTion and Moderately RedUceD Ejection Fraction N/A
Completed NCT01216995 - Safety and Efficacy of Adipose Derived Regenerative Cells (ADRCs) Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (AMI) Phase 2
Withdrawn NCT01678339 - Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients N/A
Completed NCT01887080 - Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program N/A
Completed NCT01673893 - ClearWay Rx Readmission Registry