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NCT03437044 · ClinicalTrials.gov registry record · Phase 4

Low Maintenance Dose Ticagrelor Versus Clopidogrel in Diabetes Patients Undergoing PCI

A Phase 4 study of Diabetes Mellitus, Type 2 and Coronary Artery Disease, sponsored by University of Florida.

Completed
Registry status
Phase 4
Development phase
40
Enrollment target
1
Study location

NCT03437044 is a Phase 4 study of Diabetes Mellitus, Type 2 and Coronary Artery Disease that has completed, run by University of Florida. The registered enrollment target is 40 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03437044, a Phase 4 study of Diabetes Mellitus, Type 2 and Coronary Artery Disease, has completed, sponsored by University of Florida.

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

Study Summary

To date there is very little PD and pharmacokinetic (PK) data on the ticagrelor 60 mg bid dosing regimen. In particular, there is no prospective PK/PD study on this dosing regimen in patients with DM who are known to have impaired response to clopidogrel therapy. Since DM patients frequently require elective PCI due to chronic progression of CAD (and not solely because of an acute thrombotic complication), and clopidogrel remains the guideline recommended P2Y12 inhibiting therapy for these patients, understanding the PD effects of the ticagrelor 60 mg bid regimen in this setting is an unmet clinical need. This is also in light of the ongoing THEMIS trial which is specifically evaluating the impact of the ticagrelor 60 mg bid dosing regimen in type 2 DM patients without a prior major CV event.

Interventions

  • DRUG Clopidogrel
  • DRUG Ticagrelor

Study Locations (1)

Florida

  • University of Florida - Jacksonville

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2018-03-14
Est. Completion 2020-06-27
Phase Phase 4

Sponsor

University of Florida

1,106 total trials

What the Registry Record Tells You About NCT03437044

The ClinicalTrials.gov registry entry for NCT03437044 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

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

NCT03437044 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT03437044 about?

NCT03437044 is a clinical study titled "Low Maintenance Dose Ticagrelor Versus Clopidogrel in Diabetes Patients Undergoing PCI". To date there is very little PD and pharmacokinetic (PK) data on the ticagrelor 60 mg bid dosing regimen. In particular, there is no prospective PK/PD study on this dosing regimen in patients with DM who are known to have impaired response to clopidogrel therapy. Since DM patients frequently require...

What is the current status of trial NCT03437044?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2018-03-14. Estimated completion is 2020-06-27.

What conditions does trial NCT03437044 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Coronary Artery Disease.

What interventions are being tested in trial NCT03437044?

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

Who is sponsoring clinical trial NCT03437044?

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

Where is trial NCT03437044 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

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