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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-05-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PCI without IV opiate

IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)

Group Type EXPERIMENTAL

Removal of Fentanyl from peri-procedural analgesia

Intervention Type OTHER

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

Lidocaine

Intervention Type DRUG

Local Anesthetic

Midazolam

Intervention Type DRUG

IV sedation

PCI with IV opiate

IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

IV peri-procedural analgesia

Lidocaine

Intervention Type DRUG

Local Anesthetic

Midazolam

Intervention Type DRUG

IV sedation

Interventions

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Removal of Fentanyl from peri-procedural analgesia

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

Intervention Type OTHER

Fentanyl

IV peri-procedural analgesia

Intervention Type DRUG

Lidocaine

Local Anesthetic

Intervention Type DRUG

Midazolam

IV sedation

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No