Ignite Creation Date:
2024-05-06 @ 8:09 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02683707
Status:
COMPLETED
Last Update Posted:
2018-06-07
First Post:
2016-02-11
Brief Title:
The Platelet Aggregation After tiCagrelor Inhibition and FentanYl Trial PACIFY
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
The Platelet Aggregation After tiCagrelor Inhibition and FentanYl Trial
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACIFY
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None