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NCT02539160 · ClinicalTrials.gov registry record · Phase 4
Impact of Chronic Kidney Disease on the Effects of Ticagrelor in Patients With Diabetes and Coronary Artery Disease
A Phase 4 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 101
- Enrollment target
NCT02539160 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 101 participants.
The verdict
NCT02539160, a Phase 4 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 101 participants
- Enrollment target
Study Summary
Patients with diabetes mellitus (DM) are at increased risk of atherothrombotic events. Importantly, DM is a key risk factor for the development of chronic kidney disease (CKD), which further enhances atherothrombotic risk. Clopidogrel is the most widely used platelet P2Y12 receptor inhibitor. However, despite its clinical benefit, patients with DM and CKD frequently experience recurrent atherothrombotic events. Ticagrelor is an oral, reversible, non-competitive P2Y12 receptor inhibitor with more potent and consistent platelet inhibition than clopidogrel. In large-scale clinical investigation, ticagrelor significantly reduced ischemic events to a greater extent than clopidogrel, a finding that was consistent also among DM patients. To date there has been no analysis on the efficacy of ticagrelor in DM patients according to CKD status. Moreover, although pharmacodynamic (PD) studies showed enhanced platelet inhibition associated with ticagrelor, it is unknown how this may be affected by CKD status. Ultimately, how PK/PD profiles of different ticagrelor dosing regimens may be affected by DM and CKD status is also unknown. The proposed study is aimed to show the impact of CKD status among patients with DM and coronary artery disease) CAD on PD and PK profiles of ticagrelor used at 2 doses (90mg bid and 60mg bid) in the setting of a prospective, randomized, cross-over trial.
Interventions
- DRUG ticagrelor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2016-02 |
| Est. Completion | 2020-06-17 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02539160
The ClinicalTrials.gov registry entry for NCT02539160 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ticagrelor is the first listed.
NCT02539160 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02539160 about?
NCT02539160 is a clinical study titled "Impact of Chronic Kidney Disease on the Effects of Ticagrelor in Patients With Diabetes and Coronary Artery Disease". Patients with diabetes mellitus (DM) are at increased risk of atherothrombotic events. Importantly, DM is a key risk factor for the development of chronic kidney disease (CKD), which further enhances atherothrombotic risk. Clopidogrel is the most widely used platelet P2Y12 receptor inhibitor. Howeve...
What is the current status of trial NCT02539160?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 101 participants. The study started on 2016-02. Estimated completion is 2020-06-17.
What interventions are being tested in trial NCT02539160?
The interventions under investigation include: ticagrelor (DRUG).
Who is sponsoring clinical trial NCT02539160?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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