Ignite Creation Date:
2024-05-06 @ 7:26 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02539160
Status:
COMPLETED
Last Update Posted:
2022-01-28
First Post:
2015-08-31
Brief Title:
Impact of Chronic Kidney Disease on the Effects of Ticagrelor in Patients With Diabetes and Coronary Artery Disease
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Impact of Chronic Kidney Disease on the Pharmacodynamic and Pharmacokinetic Effects of Ticagrelor in Patients With Diabetes Mellitus and Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2022-01
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:
None
Brief Summary:
Patients with diabetes mellitus DM are at increased risk of atherothrombotic events Importantly DM is a key risk factor for the development of chronic kidney disease CKD which further enhances atherothrombotic risk Clopidogrel is the most widely used platelet P2Y12 receptor inhibitor However despite its clinical benefit patients with DM and CKD frequently experience recurrent atherothrombotic events Ticagrelor is an oral reversible non-competitive P2Y12 receptor inhibitor with more potent and consistent platelet inhibition than clopidogrel In large-scale clinical investigation ticagrelor significantly reduced ischemic events to a greater extent than clopidogrel a finding that was consistent also among DM patients To date there has been no analysis on the efficacy of ticagrelor in DM patients according to CKD status Moreover although pharmacodynamic PD studies showed enhanced platelet inhibition associated with ticagrelor it is unknown how this may be affected by CKD status Ultimately how PKPD profiles of different ticagrelor dosing regimens may be affected by DM and CKD status is also unknown The proposed study is aimed to show the impact of CKD status among patients with DM and coronary artery disease CAD on PD and PK profiles of ticagrelor used at 2 doses 90mg bid and 60mg bid in the setting of a prospective randomized cross-over trial
Detailed Description:
Patients with diabetes mellitus DM are at increased risk of atherothrombotic events Importantly DM is a key risk factor for the development of chronic kidney disease CKD which further enhances atherothrombotic risk These observations underscore the importance of antiplatelet therapy for prevention of atherothrombotic recurrences in these high-risk patients Clopidogrel is the most widely used platelet P2Y12 receptor inhibitor However despite its clinical benefit patients with DM and CKD frequently experience recurrent atherothrombotic events This may be in part due to the impaired pharmacokinetic PK and pharmacodynamic PD effects of clopidogrel in patients with DM and CKD Since both DM and CKD represent pandemic public health problems the prevalence of which will double over the next 20 years identifying antiplatelet agents with more favorable PKPD profiles is of key importance
Ticagrelor is an oral reversible non-competitive P2Y12 receptor inhibitor with more potent and consistent platelet inhibition than clopidogrel In large-scale clinical investigation ticagrelor significantly reduced ischemic events to a greater extent than clopidogrel a finding that was consistent also among DM patients In patients with CKD ticagrelor led to an even greater relative risk reduction of ischemic events including cardiovascular mortality compared to patients without CKD However to date there has been no analysis on the efficacy of ticagrelor in DM patients according to CKD status Moreover although PD studies showed enhanced platelet inhibition associated with ticagrelor it is unknown how this may be affected by CKD status Ultimately how PKPD profiles of different ticagrelor dosing regimens may be affected by DM and CKD status is also unknown The proposed study is aimed to show the impact of CKD status among patients with DM and CAD on PD and PK profiles of ticagrelor used at 2 doses 90mg bid and 60mg bid in the setting of a prospective randomized cross-over trial
Ticagrelor is an oral reversible non-competitive P2Y12 receptor inhibitor with more potent and consistent platelet inhibition than clopidogrel In large-scale clinical investigation ticagrelor significantly reduced ischemic events to a greater extent than clopidogrel a finding that was consistent also among DM patients In patients with CKD ticagrelor led to an even greater relative risk reduction of ischemic events including cardiovascular mortality compared to patients without CKD However to date there has been no analysis on the efficacy of ticagrelor in DM patients according to CKD status Moreover although PD studies showed enhanced platelet inhibition associated with ticagrelor it is unknown how this may be affected by CKD status Ultimately how PKPD profiles of different ticagrelor dosing regimens may be affected by DM and CKD status is also unknown The proposed study is aimed to show the impact of CKD status among patients with DM and CAD on PD and PK profiles of ticagrelor used at 2 doses 90mg bid and 60mg bid in the setting of a prospective randomized cross-over trial
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?:
None
Is an FDA AA801 Violation?:
None