Ignite Creation Date:
2024-07-17 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501443
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-21
Brief Title:
LATAM LOWERS LDL-C
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Latin America Lipid Optimization After Acute Event in Patients With AthErosclerotic CardiovasculaR DiseaSe and High LDL-C
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
This is an open label patient-level 11 randomized clinical trial in a multi-country study aiming to evaluate the real-world impact of inclisiran Usual Care UC vs UC alone on LDL-C lowering patient-reported outcomes and healthcare resource utilization in an in-hospital population of patients admitted during the acute setting stabilized and before discharge following an acute cardiovascular event
Detailed Description:
The primary objective is to evaluate the impact of inclisiran plus usual care on LDL-C lowering versus usual care after acute MI confirmed ischemic stroke or urgent coronary revascularization
The secondary objective is to compare the LDL-C reduction of both arms in target population
Study completion for an individual participant is defined as when the participant finishes the last visit day 330 and any assessments associated with that visit
The secondary objective is to compare the LDL-C reduction of both arms in target population
Study completion for an individual participant is defined as when the participant finishes the last visit day 330 and any assessments associated with that visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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