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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 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 30 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02403830
The ClinicalTrials.gov registry entry for NCT02403830 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02403830 reports 0 study locations.
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.
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