Ignite Creation Date:
2024-05-05 @ 10:52 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01201837
Status:
COMPLETED
Last Update Posted:
2014-03-03
First Post:
2010-09-13
Brief Title:
Effect of CER-001 on Atherosclerosis in Acute Coronary Syndrome ACS Patients - Efficacy and Safety The CHI SQUARE Trial
Sponsor:
Cerenis Therapeutics SA
Organization:
Cerenis Therapeutics SA
Study Overview
Official Title:
CHI SQUARE Can HDL Infusions Significantly Quicken Atherosclerosis Regression A Phase II Multi-Center Double-Blind Ascending Dose Placebo-Controlled Dose-Finding Trial of CER-001 or Placebo in Subjects With Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2014-01
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:
CHI SQUARE
Brief Summary:
Cardiovascular disease remains the most pressing healthcare issue for developed countries and is becoming so for developing countries There are a number of chronic therapies available for long-term management of risk Short term therapies for subjects with an acute event such as an episode of acute coronary syndrome ACS are focused on reperfusion and removing thrombus but most subsequent events are caused by atherosclerotic plaque rupture at a different site There are no approved therapies that can rapidly reduce the burden of unstable inflamed plaque in the overall coronary vascular bed HDL has multiple actions that could lead to atherosclerotic plaque stabilization such as rapid removal of large quantities of cholesterol from the vasculature improvement in endothelial function protection against oxidative damage and reduction in inflammation This study will assess the effects of CER-001 an ApoA-I-based HDL mimetic on indices of atherosclerotic plaque progression and regression as assessed by intravascular ultrasound IVUS measurements in patients with ACS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None