Impact of Chronic Kidney Disease on Clopidogrel Effects in Diabetes Mellitus

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: Scott R. MacKenzie Foundation
• Treatments: Clopidogrel; Ticlopidine

Criteria

Inclusion Criteria:

• Type 2 DM, defined according to ADA definition, on treatment with oral hypoglycemic agents and/or insulin

• Angiographically documented CAD

• On treatment with low-dose aspirin (81mg/day) for ≥30 days as part of standard of care.

Exclusion Criteria:

• Use of any antiplatelet therapy (except aspirin) in prior 30 days

• Use of parenteral or oral anticoagulation

• Active bleeding

• High risk of bleeding

• Clinical indication to be on a P2Y12 receptor inhibitor

• End-stage renal disease on hemodialysis

• Any active malignancy

• Platelet count < 100x106/µl

• Hemoglobin <9 g/dl

• Severe known liver disease

• Hemodynamic instability

• Known allergy to clopidogrel

• Pregnant / lactating females (women of childbearing age must use reliable birth control).