Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study of Diabetes Mellitus, Type 2 and Coronary Artery Disease, sponsored by University of Florida.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary end-point of the study is the comparison of the PRU determined by VerifyNow PRU between between aspirin plus ticagrelor 60 mg and ticagrelor 60 mg monotherapy (trough effect pre-dosing). The VerifyNow System is a turbidimetric based optical detection system which measures platelet induced aggregation as an increase in light transmittance. The assay is based on microbead agglutination induced by adenosine diphosphate (ADP). The instrument measures this change in optical signal and rep
Conditions Studied
Interventions
- DRUG Ticagrelor monotherapy
- DRUG Ticagrelor plus aspirin
- DRUG Clopidogrel with aspirin
Study Locations (1)
Florida
- University of Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2021-03-31 |
| Est. Completion | 2024-06-15 |
| Phase | Phase 4 |
What the finished NCT04484259 record still lists
NCT04484259 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04484259's enrollment target sits among peer trials
105 198th of 348 higher than 150 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Effects of Semaglutide on Intracranial Blood Flow and Brain-Barrier Permeability in Type-2 Diabetes
RECRUITING · Phase 4
-
Knee Osteoarthritis Treatment With Zilretta vs. Kenalog in the Context of Type II Diabetes
RECRUITING · Phase 4
-
Effect of Continuing Versus Holding Metformin During Hospitalizations.
RECRUITING · Phase 4
-
Surgical or Medical Treatment
ACTIVE NOT RECRUITING · Phase 4
-
Afrezza® Dosing Optimization Study
COMPLETED · Phase 4
-
Effect of Thiazolidinedione Treatment Vascular Risk Markers
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03372317 · 105 participants
Tau PET in Imaging and Cognition: Healthy Adults From 55-90
- NCT04253964 · 105 participants · Phase 2
Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy
- NCT04742452 · 105 participants · NA
Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears
- NCT04875429 · 105 participants · NA
Zenith® Fenestrated+ Clinical Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI