Ignite Creation Date:
2024-05-06 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03473223
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2018-03-14
Brief Title:
Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome
Sponsor:
CSL Behring
Organization:
CSL Behring
Study Overview
Official Title:
A Phase 3 Multicenter Double-blind Randomized Placebo-controlled Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects With Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2024-05
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:
AEGIS-II
Brief Summary:
This is a phase 3 multicenter double-blind randomized placebo-controlled parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events MACE - cardiovascular CV death myocardial infarction MI and stroke in subjects with acute coronary syndrome ACS diagnosed with either ST-segment elevation myocardial infarction STEMI or non-ST-segment elevation myocardial infarction NSTEMI including those managed with percutaneous coronary intervention PCI or medically managed
Detailed Description:
None
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