Ignite Creation Date:
2024-05-06 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05210725
Status:
UNKNOWN
Last Update Posted:
2022-04-20
First Post:
2022-01-13
Brief Title:
Trained Immunity by Dual-pathway Inhibition in Coronary Artery Disease
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Trained Immunity by Dual-pathway Inhibition Low-dose Rivaroxaban and Acetylsalicylic Acid in Coronary Artery Disease
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
ACTIVE_NOT_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:
DUALCAD
Brief Summary:
Coronary artery disease CAD is a manifestation of systemic atherosclerosis for which single antiplatelet therapy SAPT is indicated if patients are stable Recently dual pathway inhibition DPI by combining a low-dose factor Xa inhibitor rivaroxaban25mg twice daily with a single platelet inhibitor ASA has been demonstrated to be beneficial in treating CAD The exact mechanisms underlying the benefits of DPI are not completely understood CAD is characterised by a state of chronic low-grade inflammation where monocytes from CAD patients have a higher immune responsiveness to ex vivo stimulation with lipopolysaccharide LPS compared to healthy matched controls Surprisingly the investigators have recently observed an elevation in ex vivo immune responsiveness to LPS stimulation when switching from ASA monotherapy to DPI of ASA combined with rivaroxaban inpatients with peripheral arterial disease n11 unpublished Remarkably this was associated with no changes in systemic inflammation as determined by Olink proteomics analysis These findings suggest that factor Xa inhibitors can enhance immune cell responsiveness despite being clinically beneficial to CAD The exact mechanisms contributing to the observed increased immune responsiveness remain unexplored
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?:
None
Is an FDA AA801 Violation?:
None