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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: Completed Phase 4 study of Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD), sponsored by University of Florida.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Comparison of platelet reactivity measured as PRI assessed by VASP after a 600 mg clopidogrel LD between DM patients with and without CKD
Conditions Studied
Interventions
- DRUG Clopidogrel
- DRUG Clopidogrel active metabolite
Study Locations (1)
Florida
- University of Florida Jacksonville - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2019-08-22 |
| Est. Completion | 2022-05-31 |
| Phase | Phase 4 |
What the finished NCT03774394 record still lists
NCT03774394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 520-participant average among 24 other Type 2 Diabetes Mellitus (T2DM) trials with a reported enrollment target (88% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03774394's enrollment target sits among peer trials
61 18th of 24 higher than 7 of 24 other Type 2 Diabetes Mellitus (T2DM) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus (T2DM) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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