Impact of Chronic Kidney Disease on the Effects of Ticagrelor in Patients With Diabetes and Coronary Artery Disease
Status:
Completed
Trial end date:
2020-06-17
Target enrollment:
Participant gender:
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 PD studies showed enhanced platelet
inhibition associated with ticagrelor, it is unknown how this may be affected by CKD status.
Ultimately, how PK/PD 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.