Phase 4 N=61 Treatment

Impact of Chronic Kidney Disease on Clopidogrel Effects in Diabetes Mellitus

Chronic Kidney Disease (CKD) · Type 2 Diabetes Mellitus (T2DM) · Coronary Artery Disease (CAD)

Bottom Line

View on ClinicalTrials.gov: NCT03774394 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Platelet Reactivity Index (PRI) Assessed by VASP. The Cutoff for High Platelet Reactivity is >50% — 67.5; 67.2 PRI%

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Clopidogrel (Drug); Clopidogrel active metabolite (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: May 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Platelet Reactivity Index (PRI) Assessed by VASP. The Cutoff for High Platelet Reactivity is >50%	92.7; 94.4	—
SECONDARY Clopidogrel Active Metabolite Concentration	47.1; 39.6	—

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.

Eligibility 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).

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Data sourced from ClinicalTrials.gov (NCT03774394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.