Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05739383
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-02-13
Brief Title:
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multicenter Study to Evaluate the Effect of Inclisiran on Preventing Major Adverse Cardiovascular Events in High-risk Primary Prevention Patients VICTORION-1 PREVENT
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:
None
Brief Summary:
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram mg subcutaneous sc administered on Day 1 Day 90 and every 6 months thereafter in patients at high cardiovascular CV risk without a prior major atherosclerotic cardiovascular disease ASCVD event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events 4P-MACE defined as a composite of CV death non-fatal myocardial infarction MI non-fatal ischemic stroke and urgent coronary revascularization compared to placebo
Detailed Description:
The purpose of this study is to evaluate inclisiran sodium 300 mg sc equivalent to 284 mg inclisiran compared to placebo on reducing the risk of 4P-MACE in adult patients at high risk for their first major adverse cardiovascular event
Randomized participants will receive study medication inclisiran or placebo administered sc on Day 1 Day 90 then every 6 months thereafter This is an event-driven study Therefore the study will continue until the required number of clinical events have occurred across both treatment arms and all participants have a minimum of 3 years of follow-up during the double-blind treatment period
Randomized participants will receive study medication inclisiran or placebo administered sc on Day 1 Day 90 then every 6 months thereafter This is an event-driven study Therefore the study will continue until the required number of clinical events have occurred across both treatment arms and all participants have a minimum of 3 years of follow-up during the double-blind treatment period
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