Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431763
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-04-30
Brief Title:
A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Multicenter Open-label Trial Comparing the Effectiveness of Inclisiran to Bempedoic Acid on LDL Cholesterol LDL-C Lowering in Participants With Atherosclerotic Cardiovascular Disease VICTORION-CHALLENGE
Status:
RECRUITING
Status Verified Date:
2024-09
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 study is a phase IV open-label randomized study designed to evaluate the efficacy of Inclisiran vs bempedoic acid BPA in 400 adult subjects 18 years at very high and high risk for cardiovascular events as defined by the cardiovascular risk categories in the 2019 ESCEAS guidelines for the management of dyslipidemias Mach et al 2020 and elevated levels of LDL-C 70 mgdL despite being on a maximally tolerated high-intensity HI statin dose - Ezetimibe Currently BPA is recommended ahead of injectables by German HTA body GBA A head-to-head trial is proposed to provide robust scientific data on the superiority of Inclisiran vs BPA and to support the early use of Inclisiran
Detailed Description:
During the screening period study eligibility will be assessed and the participants individual LDL-C target according to guideline Mach et al 2020 will be determined Among other criteria at screening a participant must be on a stable maximally tolerated dose of a HI statin with either atorvastatin 40 mg once a day QD or rosuvastatin 20 mg QD - Ezetimibe 10mg for 4 weeks with which however a target LDL-C of 70 mgdL is not reached
During the open-label treatment period all participants who fulfill the inclusionexclusion criteria will be randomized at V1 Day 1 in a 11 open-label fashion to either Inclisiran sodium 300 mg sc administered at Day 1 and Day 90 or to BPA tablets 180 mg po given once daily Participants will be required to maintain their background lipid-lowering treatment maximally tolerated statin dose - Ezetimibe unchanged for the duration of the study The end of treatment EOT is reached at day 150
A Safety-Follow-up call will be conducted 30 days after EOT visit Day 180
The overall study duration is approximately 190 days but can vary depending on individual screening and the visit windows allowed for the treatment period and EOS visit
During the open-label treatment period all participants who fulfill the inclusionexclusion criteria will be randomized at V1 Day 1 in a 11 open-label fashion to either Inclisiran sodium 300 mg sc administered at Day 1 and Day 90 or to BPA tablets 180 mg po given once daily Participants will be required to maintain their background lipid-lowering treatment maximally tolerated statin dose - Ezetimibe unchanged for the duration of the study The end of treatment EOT is reached at day 150
A Safety-Follow-up call will be conducted 30 days after EOT visit Day 180
The overall study duration is approximately 190 days but can vary depending on individual screening and the visit windows allowed for the treatment period and EOS 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