Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342609
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2024-03-16
Brief Title:
Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With Stable Coronary Artery Disease
Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Organization:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study Overview
Official Title:
Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With STable CoROnary Artery Disease CoMpared to Placebo - EKSTROM Trial
Status:
COMPLETED
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:
EKSTROM
Brief Summary:
This is a randomized double-blind placebo-controlled investigator-initiated trial that compares Colchicine 05mgday with placebo among patients with stable CAD Subjects will be educated to maintain medication compliance with other prescribed medications
Detailed Description:
The goal of this study is to evaluate whether treatment with Colchicine results in greater change of low attenuation plaque volume from baseline level when compared to placebo in subjects with stable Coronary Artery Disease CAD The Primary objective of the study is to determine progression rates of low attenuation plaque under influence of Colchicine as compared to placebo The study will also look to determine effects of Colchicine on the morphology and composition non -calcified coronary plaque progression of total plaque volume progression of high vulnerability features of plaque and to assess whether these effects are modulated by a change in HsCRP and other markers of inflammation HsCRP IL-6 IL-1α IL-1β IL-18 as well as the effect on Pericoronary adipose tissue PCAT and Epicardial adipose tissue EAT volume and well as on the endothelial function
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?:
True
Is an FDA AA801 Violation?:
None