Ignite Creation Date:
2024-05-06 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03570697
Status:
COMPLETED
Last Update Posted:
2022-05-03
First Post:
2018-06-18
Brief Title:
Imaging of Coronary Plaques in Participants Treated With Evolocumab
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
High-Resolution Assessment of Coronary Plaques in a Global Evolocumab Randomized Study HUYGENS
Status:
COMPLETED
Status Verified Date:
2022-04
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:
None
Brief Summary:
To evaluate the effect of evolocumab on fibrous cap thickness FCT in participants with non-ST-elevation acute coronary syndrome NSTE-ACS who are taking maximally tolerated statin therapy
Detailed Description:
This study seeks to identify morphologic changes such as increase in FCT in atherosclerotic plaques associated with treatment with evolocumab and maximally tolerated statin therapy with or without additional lipid-modifying medication in patients presenting with NSTE-ACS using optical coherence tomography OCT primary secondary and exploratory endpoints
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 |
|---|---|---|---|
| 2017-003236-37 | EUDRACT_NUMBER | None | None |