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Clinical trial

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)

ID
Name
IRB201801870 -A
Description
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.
Trial arms
Trial start
2019-08-22
Estimated PCD
2022-05-23
Trial end
2022-05-31
Status
Completed
Phase
Early phase I
Treatment
Clopidogrel
Both CKD and Non-CKD patients will be administered a 600-mg LD of clopidogrel followed by a single 75-mg MD administered after 24 hours.
Arms:
Diabetes Mellitus patients with Chronic Kidney Disease, Diabetes Mellitus patients without Chronic Kidney Disease
Other names:
Plavix
Clopidogrel active metabolite
In both CKD and Non-CKD patients, blood samples collected at baseline only (before clopidogrel LD administration) will be incubated with escalating concentrations of clopidogrel active metabolite (1, 3 and 10 μM)
Arms:
Diabetes Mellitus patients with Chronic Kidney Disease, Diabetes Mellitus patients without Chronic Kidney Disease
Other names:
Plavix
Size
61
Primary endpoint
Platelet Reactivity Index (PRI) Assessed by VASP. The Cutoff for High Platelet Reactivity is >50%
6 hours
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).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 61, 'type': 'ACTUAL'}}
Updated at
2023-08-21

1 organization

1 product

3 indications

Organization
University of Florida
Product
Clopidogrel
Indication
Chronic Kidney Disease
Indication
Type 2 Diabetes Mellitus
Indication
coronary artery disease