Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04837001
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2021-04-06
Brief Title:
Evaluation in STEMI Patients Using FDY-5301
Sponsor:
Faraday Pharmaceuticals Inc
Organization:
Faraday Pharmaceuticals Inc
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IOCYTE AMI-3
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-001924-16 | EUDRACT_NUMBER | None | None |