The Platelet Aggregation After tiCagrelor Inhibition and FentanYl Trial (PACIFY)

Coronary Artery Disease Clinical Trial

— PACIFY  

Official title:

The Platelet Aggregation After tiCagrelor Inhibition and FentanYl Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683707
• Other study ID #: IRB00089755
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: May 25, 2017

Study information

• Verified date: May 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: May 25, 2017
• Est. primary completion date: May 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• undergoing clinically indicated PCI; >18 years of age; able for PO medications and to provide informed consent

Exclusion Criteria:

• pregnant; any DAPT(clopidogrel, prasugrel, ticagrelor) within 14 days of enrollment; known coagulation disorders; active treatment with oral anticoagulant or low molecular weight heparin; impaired renal or hepatic function; platelets < 100 x10 3 /mcl; planned use of Glycoprotein 2b3a for PCI; Prior Trans Arterial Valve Replacement (TAVR) or planned TAVR post PCI; and contraindications to ticagrelor or opiates.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Removal of Fentanyl from peri-procedural analgesia
Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI)

Drug:
• Fentanyl
IV peri-procedural analgesia
• Lidocaine
Local Anesthetic
• Midazolam
IV sedation

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital and University School of Medicicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ticagrelor Pharmacokinetics	Area under the curve for Ticagrelor Absorption	Measured over 24 hours (at 0, 0.5, 1, 2, 4, and 24 hours)
Secondary	Single Time-point Platelet Reactivity Using Verify Now	Blood test of Platelet Cell Reactivity using Verify Now (P2Y12 Reactivity Units)	Measured at 2 hours
Secondary	Platelet Reactivity Using Light Transmission Aggregometry	Blood test of Platelet Cell Reactivity using Light Transmission Aggregometry (reported as percent of baseline aggregation in response to adenosine diphosphate stimulation)	Measured at 2 hours
Secondary	Patient Self-reported Pain	Patient self report of pain using a visual analog scale (VAS). Scale ranges from 0 to 10 with 0 being "No pain" and 10 being "Most severe pain".	2 hours