Ignite Creation Date:
2024-05-06 @ 12:30 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03774394
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2018-12-11
Brief Title:
Impact of Chronic Kidney Disease on Clopidogrel Effects in Diabetes Mellitus
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Impact of Chronic Kidney Disease CKD on Pharmacodynamic Profiles of the P2Y12 Receptor Inhibitor Clopidogrel in the Setting of Type 2 Diabetes Mellitus T2DM and Coronary Artery Disease CAD
Status:
COMPLETED
Status Verified Date:
2023-07
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:
None
Brief Summary:
Patients with diabetes mellitus DM and chronic kidney disease CKD are at increased risk of atherothrombotic events Clopidogrel is the most widely used platelet P2Y12 receptor inhibitor in patients with coronary artery disease CAD However despite its benefits many patients still experience recurrent atherothrombotic events The proposed study will test the central hypothesis that in DM patients the presence of CKD reduces clopidogrel-mediated P2Y12 inhibitory effects through synergistic mechanisms which include upregulation of the P2Y12 signaling pathway and impaired clopidogrel metabolism
Detailed Description:
Patients with diabetes mellitus DM and coexisting chronic kidney disease CKD are at increased risk of atherothrombotic events underscoring the importance of secondary prevention antiplatelet therapy in these high-risk patients Clopidogrel is the most widely used platelet P2Y12 receptor inhibitor in patients with coronary artery disease CAD However despite its clinical benefits many patients still experience recurrent atherothrombotic events This is in part due to the impaired effects of clopidogrel in DM patients particularly among those with coexisting CKD However underlying mechanisms leading to magnification of impaired clopidogrel response among DM patients with CKD remain unexplored The ever growing prevalence of CKD in patients with DM and their high risk of recurrent events underscores the need to define such mechanisms as this may set the basis for identifying treatment regimens leading to more effective platelet inhibition and cardiovascular protection in these high-risk patients The proposed study will test the central hypothesis that in DM patients the presence of CKD reduces clopidogrel-mediated P2Y12 inhibitory effects through synergistic mechanisms which include upregulation of the P2Y12 signaling pathway and impaired clopidogrel metabolism Comprehensive pharmacokinetic and pharmacodynamic assessments including ex vivo and in vitro experiments evaluating the impact of CKD on antiplatelet drug response in DM patients are proposed
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?:
False
Is an FDA AA801 Violation?:
None