CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 61 enrolled
Drug / intervention
Clopidogrel +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03774394
NCT03774394Phase 4Completed
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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)

University of Florida·interventional·Posted Dec 13, 2018·Updated Aug 21, 2023

In Brief

A Phase 4 clinical trial evaluating Clopidogrel and Clopidogrel active metabolite for Chronic Kidney Disease (CKD) and 2 related conditions. Completed, enrolled 61 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease (CKD), Type 2 Diabetes Mellitus (T2DM), Coronary Artery Disease (CAD)
CountriesUnited States
CollaboratorsScott R. MacKenzie Foundation

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedDec 13, 2018
Enrollment StartAug 22, 2019
Primary CompletionMay 23, 2022
Study CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.6 years ago

Interventions

Clopidogreldrug

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.

Clopidogrel active metabolitedrug

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)