Ignite Creation Date:
2024-05-06 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05322200
Status:
UNKNOWN
Last Update Posted:
2022-10-27
First Post:
2022-02-11
Brief Title:
The POST-ACS Study
Sponsor:
Swansea Bay University Health Board
Organization:
Swansea Bay University Health Board
Study Overview
Official Title:
Potential Impact of Oral Semaglutide on Coronary Artery Disease Progression Following Acute Coronary Syndrome The POST-ACS Study
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
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:
Individuals with T2DM have a two-fold excess risk of cardiovascular CV events compared with their non-diabetic counterparts
Although it is the primary cause of death in T2DM there is no significant evidence that intensive glucose lowering reduces CV events Multiple Cardiovascular Outcome Trials have suggested CV safety and benefit with the new class hypoglycemic agents - glucagon-like peptide 1 receptor agonists GLP-RAs in patients with DM and a high CV risk profile with a mechanism not directly dependent on their glucose-lowering effect Varies theories regarding the mechanism of action of GLP-RAs on reducing CV events have been proposed including reducing inflammation protection of ischemiareperfusion injury and improvement in endothelial dysfunction but the effects of these new agents on in-vivo atherosclerotic plaque burden is currently unproven
The investigators hypothesize that compared with placebo 1-year treatment with the oral GLP-RA Semaglutide will result in a regression of necrotic core within potentially vulnerable coronary plaques identified using the novel method Plaque Maps analysis on CT Coronary Angiography in patients with raised HbA1c 57 after acute coronary syndromes ACS
Methods One hundred forty patients admitted with ACS and have raised HbA1c 57 will be enrolled in the trial and randomized in a 11 blinded fashion to receive conventional therapy and initiation of Semaglutide or conventional therapy plus placebo
All patients will have a CT Coronary Angiography with Plaque Map analysis of atherosclerotic burden plaque composition and presence of potentially vulnerable plaque morphology at baseline prior to therapy initiation and following 12 months of treatment In addition to help elucidate the potential mechanisms of any anti-atherosclerotic effects patients will have a non-invasive assessment of vascular function assessed by aortic pulse wave velocity and comprehensive biomarker analysis of inflammation atherogenesis and oxidative stress
Although it is the primary cause of death in T2DM there is no significant evidence that intensive glucose lowering reduces CV events Multiple Cardiovascular Outcome Trials have suggested CV safety and benefit with the new class hypoglycemic agents - glucagon-like peptide 1 receptor agonists GLP-RAs in patients with DM and a high CV risk profile with a mechanism not directly dependent on their glucose-lowering effect Varies theories regarding the mechanism of action of GLP-RAs on reducing CV events have been proposed including reducing inflammation protection of ischemiareperfusion injury and improvement in endothelial dysfunction but the effects of these new agents on in-vivo atherosclerotic plaque burden is currently unproven
The investigators hypothesize that compared with placebo 1-year treatment with the oral GLP-RA Semaglutide will result in a regression of necrotic core within potentially vulnerable coronary plaques identified using the novel method Plaque Maps analysis on CT Coronary Angiography in patients with raised HbA1c 57 after acute coronary syndromes ACS
Methods One hundred forty patients admitted with ACS and have raised HbA1c 57 will be enrolled in the trial and randomized in a 11 blinded fashion to receive conventional therapy and initiation of Semaglutide or conventional therapy plus placebo
All patients will have a CT Coronary Angiography with Plaque Map analysis of atherosclerotic burden plaque composition and presence of potentially vulnerable plaque morphology at baseline prior to therapy initiation and following 12 months of treatment In addition to help elucidate the potential mechanisms of any anti-atherosclerotic effects patients will have a non-invasive assessment of vascular function assessed by aortic pulse wave velocity and comprehensive biomarker analysis of inflammation atherogenesis and oxidative stress
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None