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NCT04484259 · ClinicalTrials.gov registry record · Phase 4

Ticagrelor With and Without Aspirin in Patients With Diabetes Mellitus

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
105
Enrollment target
1
Study location

NCT04484259 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 105 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04484259, 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
105 participants
Enrollment target
1
Study location

Study Summary

Recent studies have shown that withdrawing aspirin and maintaining P2Y12 inhibitor monotherapy for up to 12 months post-PCI, after a brief period of DAPT, reduces bleeding without increasing ischemic harm. Such effects have shown to of particular benefit in patients with diabetes mellitus (DM). However, if an aspirin-free approach can be considered after this time frame is a matter of debate. The aim of this study is to assess the PD effects of ticagrelor 60 mg with and without aspirin therapy in CAD patients and to compare this with a standard DAPT regimen of aspirin plus clopidogrel.

Interventions

  • DRUG Ticagrelor monotherapy
  • DRUG Ticagrelor plus aspirin
  • DRUG Clopidogrel with aspirin

Study Locations (1)

Florida

  • University of Florida - Jacksonville

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2021-03-31
Est. Completion 2024-06-15
Phase Phase 4

Sponsor

University of Florida

1,106 total trials

What the Registry Record Tells You About NCT04484259

The ClinicalTrials.gov registry entry for NCT04484259 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 105 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 (98% 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 3 interventions - of which Ticagrelor monotherapy is the first listed.

NCT04484259 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT04484259 about?

NCT04484259 is a clinical study titled "Ticagrelor With and Without Aspirin in Patients With Diabetes Mellitus". Recent studies have shown that withdrawing aspirin and maintaining P2Y12 inhibitor monotherapy for up to 12 months post-PCI, after a brief period of DAPT, reduces bleeding without increasing ischemic harm. Such effects have shown to of particular benefit in patients with diabetes mellitus (DM). Howe...

What is the current status of trial NCT04484259?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 105 participants. The study started on 2021-03-31. Estimated completion is 2024-06-15.

What conditions does trial NCT04484259 study?

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

What interventions are being tested in trial NCT04484259?

The interventions under investigation include: Ticagrelor monotherapy (DRUG), Ticagrelor plus aspirin (DRUG), Clopidogrel with aspirin (DRUG).

Who is sponsoring clinical trial NCT04484259?

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

Where is trial NCT04484259 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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