Ignite Creation Date:
2024-05-06 @ 7:12 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02484378
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2015-06-25
Brief Title:
CER-001 Atherosclerosis Regression ACS Trial
Sponsor:
Cerenis Therapeutics SA
Organization:
Cerenis Therapeutics SA
Study Overview
Official Title:
CER-001 Atherosclerosis Regression ACS Trial A Phase II Multi-Center Double-Blind Placebo-Controlled Dose-Focusing Trial Of Cer-001 In Subjects With Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2017-01
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:
CARAT
Brief Summary:
The purpose of this study is to assess the impact of ten intravenous infusions of 3 mgkg CER 001 vs placebo given at weekly intervals for ten weeks on atherosclerotic plaque volume as measured by coronary IVUS when administered to subjects presenting with Acute Coronary Syndrome ACS with significant plaque volume
Detailed Description:
Subjects will be required to have at least one epicardial coronary artery suitable for IVUS imaging A suitable target artery for IVUS imaging will be determined at baseline as having stenosis of up to 50 and meeting all angiographic inclusion criteria Subjects having met all eligibility criteria will be randomized to receive an intravenous infusion of CER 001 3 mgkg or placebo within 14 days of event presentation Randomized subjects will then return at 7 day intervals for nine additional infusions A follow up IVUS will be conducted at 14 days after the last infusion The total study duration from randomization to follow up IVUS for a completed study can range from approximately 9 to 12 weeks
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