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NCT02683707 · ClinicalTrials.gov registry record · Phase 4
The Platelet Aggregation After tiCagrelor Inhibition and FentanYl Trial (PACIFY)
A Phase 4 study of Coronary Artery Disease, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 4
- Development phase
- 212
- Enrollment target
- 1
- Study location
NCT02683707 is a Phase 4 study of Coronary Artery Disease that has completed, run by Johns Hopkins University. The registered enrollment target is 212 participants, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02683707, a Phase 4 study of Coronary Artery Disease, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 212 participants
- Enrollment target
- 1
- Study location
Study Summary
With potent analgesic properties, perceived hemodynamic benefits and limited alternatives, opiates are the analgesic mainstay for acute coronary syndrome (ACS) patients reporting peri-procedural pain or nitrate-resistant chest pain. However, large observational studies suggest that opiate administration during ACS may result in adverse cardiovascular outcomes. Complimenting this, a number of recent mechanistic studies have demonstrated delayed and attenuated effects of oral dual anti-platelet therapy (DAPT) on platelet inhibition endpoints among subjects receiving intravenous morphine. These studies support the hypothesis that morphine delays the gastrointestinal absorption of DAPT medications. However, no data exist on the impact of intravenous fentanyl, a systemic opioid analgesic routinely administered during percutaneous coronary intervention (PCI) procedures, on the platelet inhibition effects of DAPT. The investigators hypothesize that, similar to morphine, fentanyl administered at the time of PCI will reduce and delay the effect of DAPT on platelet function. As such, the primary aim of this study is to test the impact of intravenous fentanyl on residual platelet reactivity by randomizing patients undergoing PCI to a strategy of peri-procedural benzodiazepine plus non-systemic local analgesia or to the current standard of benzodiazepine plus intravenous fentanyl. Given the critical need for rapid and robust inhibition of platelet function during PCI, this trial has true potential to change clinical practice, particularly if the investigators demonstrate reduced DAPT absorption and elevated residual platelet reactivity among patients receiving fentanyl during PCI.
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Lidocaine
- DRUG Fentanyl
- OTHER Removal of Fentanyl from peri-procedural analgesia
Study Locations (1)
Maryland
- Johns Hopkins Hospital and University School of Medicicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2016-03 |
| Est. Completion | 2017-05-25 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02683707
The ClinicalTrials.gov registry entry for NCT02683707 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 212 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (84% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 4 interventions - of which Midazolam is the first listed.
NCT02683707 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02683707 about?
NCT02683707 is a clinical study titled "The Platelet Aggregation After tiCagrelor Inhibition and FentanYl Trial (PACIFY)". With potent analgesic properties, perceived hemodynamic benefits and limited alternatives, opiates are the analgesic mainstay for acute coronary syndrome (ACS) patients reporting peri-procedural pain or nitrate-resistant chest pain. However, large observational studies suggest that opiate administra...
What is the current status of trial NCT02683707?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 212 participants. The study started on 2016-03. Estimated completion is 2017-05-25.
What conditions does trial NCT02683707 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT02683707?
The interventions under investigation include: Midazolam (DRUG), Lidocaine (DRUG), Fentanyl (DRUG), Removal of Fentanyl from peri-procedural analgesia (OTHER).
Who is sponsoring clinical trial NCT02683707?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02683707 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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