Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249165
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-01-31
Brief Title:
VictORION-INCLUSION Evaluating Inclisiran for Cholesterol Managment in Heart Disease
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
VictORION-INCLUSION Evaluating INClisiran as a soLUtion to Improve LDL-C Management and cloSe Care Gaps in an Inclusive ASCVD and ASCVD Risk Equivalent populatiON
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
V-INCLUSION
Brief Summary:
VictORION-INCLUSION V-INCLUSION seeks to evaluate the effectiveness of inclisiran as an innovative therapy with the potential to help bridge care gaps in historically understudied and undertreated populations by leveraging electronic health records EHR in multiple US Healthcare Systems HCS to systematically identify those at high risk for and already diagnosed with ASCVD for more expeditious achievement of LDL-C targets
Detailed Description:
The trial consists of two parts Part 1 is a randomized controlled multicenter open-label two arm trial comparing inclisiran and usual care versus usual care alone in an inclusive study population identified by electronic health records Part 2 is a single arm trial consisting of Part 1 usual care participants initiating inclisiran at Day 360 and receiving two additional doses on day 450 and 630 dosed in similar fashion to inclisiran UC arm in Part 1 Approximately 1440 participants will be randomized to either inclisiran usual care or to usual care only Eligible participants must be at high risk for or be diagnosed with established ASCVD prior CAD PAD CeVD event and LDL-C above treatment threshold despite treatment with statin therapy or with documented statin intolerance
The study population will consist of underrepresented and historically understudied male and female participants at least 50 female 70 underrepresented BlackAfrican American HispanicLatino Asian other and 10 rural participants of any sex or raceethnicity 18 years of age with a history of ASCVD coronary artery disease ischemic cerebrovascular disease or peripheral arterial disease or ASCVD risk equivalent HeFH Type 2 DM or 10 year ASCVD risk score 20 who have elevated LDL-C 70 mgdL or LDL-C 100 mgdL respectively despite being treated with statin therapy A total of approximately 1440 participants will be randomized to inclisiran usual care or usual care in a 11 ratio at approximately 30 US healthcare systems
The study population will consist of underrepresented and historically understudied male and female participants at least 50 female 70 underrepresented BlackAfrican American HispanicLatino Asian other and 10 rural participants of any sex or raceethnicity 18 years of age with a history of ASCVD coronary artery disease ischemic cerebrovascular disease or peripheral arterial disease or ASCVD risk equivalent HeFH Type 2 DM or 10 year ASCVD risk score 20 who have elevated LDL-C 70 mgdL or LDL-C 100 mgdL respectively despite being treated with statin therapy A total of approximately 1440 participants will be randomized to inclisiran usual care or usual care in a 11 ratio at approximately 30 US healthcare systems
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