Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05754957
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-02-23
Brief Title:
A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Placebo-controlled Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian an Oral Factor XIa Inhibitor After a Recent Acute Coronary Syndrome
Status:
RECRUITING
Status Verified Date:
2024-10
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:
LIBREXIA-ACS
Brief Summary:
The purpose of this study is to evaluate that milvexian is superior to placebo in addition to standard-of-care in reducing the risk of major adverse cardiovascular event MACE the composite of cardiovascular CV death myocardial infarction MI and ischemic stroke
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-501418-69-00 | REGISTRY | EUCT number | None |
| 70033093ACS3003 | OTHER | None | None |