Ignite Creation Date:
2024-05-06 @ 7:43 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02586155
Status:
COMPLETED
Last Update Posted:
2021-08-20
First Post:
2015-10-21
Brief Title:
Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD
Sponsor:
Resverlogix Corp
Organization:
Resverlogix Corp
Study Overview
Official Title:
A Phase III Multi-Center Double-Blind Randomized Parallel Group Placebo-Controlled Clinical Trial in High-Risk Type 2 Diabetes Mellitus T2DM Subjects With Coronary Artery Disease CAD to Determine Whether Bromodomain Extraterminal Domain BET Inhibition Treatment With RVX000222 Increases the Time to Major Adverse Cardiovascular Events MACE
Status:
COMPLETED
Status Verified Date:
2021-07
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:
BETonMACE
Brief Summary:
The purpose of this study is to determine whether bromodomain extraterminal domain BET inhibition treatment with RVX000222 in high-risk type 2 diabetes mellitus patients with coronary artery disease increases the time to major adverse cardiovascular events
Detailed Description:
The majority 75 of deaths in subjects with diabetes mellitus DM are due to atherosclerotic cardiovascular disease CVD Recent studies suggest a major adverse cardiovascular event MACE rate of 11 over 18 months in type 2 diabetes mellitus T2DM despite a baseline LDL-C of 21 mmolL Bromodomains BRDs are a family of evolutionary conserved protein-interaction modules that play key functions in chromatin organization and regulation of gene transcription One recognized family of bromodomain-containing proteins is the bromodomain and extra-terminal BET family BET inhibition represents a novel epigenetic approach to treat CAD
RVX000222 affects biological processes important in atherosclerosis and acute coronary events via selective inhibition of BET proteins RVX000222 is available as a capsule formulation with standard excipients and established stability
The BETonMACE study will focus on prevention of subsequent MACE in subjects with CAD and DM with high intensity statin therapy as co-medication
RVX000222 affects biological processes important in atherosclerosis and acute coronary events via selective inhibition of BET proteins RVX000222 is available as a capsule formulation with standard excipients and established stability
The BETonMACE study will focus on prevention of subsequent MACE in subjects with CAD and DM with high intensity statin therapy as co-medication
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