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NCT03774394 · ClinicalTrials.gov registry record · Phase 4

Impact of Chronic Kidney Disease on Clopidogrel Effects in Diabetes Mellitus

A Phase 4 study of Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD), sponsored by University of Florida.

Completed
Registry status
Phase 4
Development phase
61
Enrollment target
1
Study location

NCT03774394 is a Phase 4 study of Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD) that has completed, run by University of Florida. The registered enrollment target is 61 participants, below the 520-participant average among 24 other Type 2 Diabetes Mellitus (T2DM) trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03774394, a Phase 4 study of Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD), has completed, sponsored by University of Florida.

COMPLETED
Registry status
Phase 4
Development phase
61 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DRUG Clopidogrel
  • DRUG Clopidogrel active metabolite

Study Locations (1)

Florida

  • University of Florida Jacksonville - Jacksonville

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2019-08-22
Est. Completion 2022-05-31
Phase Phase 4

Sponsor

University of Florida

1,106 total trials

What the Registry Record Tells You About NCT03774394

The ClinicalTrials.gov registry entry for NCT03774394 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 520-participant average among 24 other Type 2 Diabetes Mellitus (T2DM) trials with a reported enrollment target (88% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Type 2 Diabetes Mellitus (T2DM) appearing as the primary indexed condition, and to 2 interventions - of which Clopidogrel is the first listed.

NCT03774394 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT03774394 about?

NCT03774394 is a clinical study titled "Impact of Chronic Kidney Disease on Clopidogrel Effects in Diabetes Mellitus". 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 ...

What is the current status of trial NCT03774394?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 61 participants. The study started on 2019-08-22. Estimated completion is 2022-05-31.

What conditions does trial NCT03774394 study?

This clinical trial studies the following conditions: Type 2 Diabetes Mellitus (T2DM), Chronic Kidney Disease (CKD), Coronary Artery Disease (CAD).

What interventions are being tested in trial NCT03774394?

The interventions under investigation include: Clopidogrel (DRUG), Clopidogrel active metabolite (DRUG).

Who is sponsoring clinical trial NCT03774394?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03774394 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.