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NCT02403830 · ClinicalTrials.gov registry record · Phase 4
Effect of Methylnaltrexone on the PK/PD Profiles of Ticagrelor in Patients Treated With Morphine
A Phase 4 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT02403830: Completed Phase 4 study, sponsored by University of Florida.
NCT02403830 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02403830, a Phase 4 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
Ticagrelor is associated with more prompt and potent antiplatelet effects compared with clopidogrel, leading to better clinical outcomes, including reduced cardiovascular mortality, across the spectrum of patients with acute coronary syndrome, including those with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). However, in this latter setting a delay in the onset of its antiplatelet effects has been shown. Morphine has been identified as a cause of delayed P2Y12 inhibition in patients with STEMI. Methylnaltrexone is a parenteral peripheral opioid receptor antagonist which has the potential to prevent or reverse opioid-induced peripherally mediated side effects without affecting analgesia. However, whether the use of intravenous methylnaltrexone may overcome the effects of morphine administration on the pharmacokinetic (PK) and pharmacodynamics (PD) profiles of ticagrelor has not been investigated yet. The proposed investigation will include patients with coronary artery disease and will have a prospective, randomized, cross-over design.
Primary Outcome
Platelet reactivity measured by VerifyNow P2Y12 2 hours after ticagrelor loading dose and reported as P2Y12 reaction units (PRU)
Interventions
- OTHER Placebo
- DRUG Morphine
- DRUG Methylnaltrexone
- DRUG Ticagrelor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-08 |
| Est. Completion | 2016-05 |
| Phase | Phase 4 |
What the finished NCT02403830 record still lists
NCT02403830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02403830 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02403830 about?
NCT02403830 is a clinical study titled "Effect of Methylnaltrexone on the PK/PD Profiles of Ticagrelor in Patients Treated With Morphine". Ticagrelor is associated with more prompt and potent antiplatelet effects compared with clopidogrel, leading to better clinical outcomes, including reduced cardiovascular mortality, across the spectrum of patients with acute coronary syndrome, including those with ST-elevation myocardial infarction ...
What is the current status of trial NCT02403830?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2015-08. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02403830?
The interventions under investigation include: Placebo (OTHER), Morphine (DRUG), Methylnaltrexone (DRUG), Ticagrelor (DRUG).
Who is sponsoring clinical trial NCT02403830?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02403830's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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