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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: Completed Phase 4 study of Diabetes Mellitus, Type 2 and Coronary Artery Disease, sponsored by University of Florida.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary endpoint of our study will be platelet reactivity, measured as PRU level using VerifyNow PRU, of ticagrelor versus clopidogrel MD at 30 days after PCI, immediately pre-dosing dosing (trough levels). PRU is a marker of platelet reactivity. Higher PRU values correspond to higher aggregation and lower response to antiplatelet therapy.
Conditions Studied
Interventions
- DRUG Clopidogrel
- DRUG Ticagrelor
Study Locations (1)
Florida
- University of Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-03-14 |
| Est. Completion | 2020-06-27 |
| Phase | Phase 4 |
What the finished NCT03437044 record still lists
NCT03437044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03437044's enrollment target sits among peer trials
40 279th of 348 higher than 66 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.
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