IOCYTE AMI-3
Research type
Research Study
Full title
IOCYTE AMI-3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intravenous FDY-5301 in Patients with an Anterior ST-Elevation Myocardial Infarction
IRAS ID
1004594
Contact name
Eric Obiri-Asante
Contact email
Sponsor organisation
Faraday Pharmaceuticals, Inc.
Eudract number
2021-001924-16
Clinicaltrials.gov Identifier
Research summary
A STEMI is associated with significant risk of dying or getting heart failure.\n\nThis type of heart attack prevents blood flow to an area of heart muscle and stops the delivery of oxygen and nutrients. If the heart artery is not quickly opened to allow blood flow, this part of the heart muscle may be permanently damaged. To help prevent heart damage, a standard procedure known as percutaneous coronary intervention (PCI) is performed by opening the inside of the blocked artery with a balloon catheter device (a long, thin tube) and maybe a stent (a tiny tube) to keep the artery open.\n\nEven if the artery is opened very quickly, there may be reperfusion injury, which causes further damage to the heart muscle because of the rapid in-flow of blood after PCI. Currently no drug is approved for the prevention of reperfusion injury. This study is evaluating an FDY-5301’s ability to prevent reperfusion injury in STEMI participants undergoing PCI.\n\nFDY-5301 is an experimental study drug. FDY-5301 has been tested in a small study of 120 STEMI participants who received a single IV dose of FDY-5301 at doses that were either below or the same as what is being given for this study. The study results suggest the participants who received FDY-5301 had smaller infarct sizes (areas of dead tissue resulting from failure of blood supply) and better cardiac function after their heart attack.\n\nThis study is being done to see if FDY-5301 can decrease the chances of death or heart failure from a heart attack. Study participants will be followed for 12 months after their heart attack to monitor these chances as well as the safety of FDY-5301. Approximately 2,300 subjects are planned to be randomized in a 1:1 ratio for this study.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0063
Date of REC Opinion
12 Apr 2022
REC opinion
Further Information Favourable Opinion