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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683707
Recruitment Status : Completed
First Posted : February 17, 2016
Results First Posted : May 9, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: Removal of Fentanyl from peri-procedural analgesia Drug: Fentanyl Drug: Lidocaine Drug: Midazolam Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Platelet Aggregation After tiCagrelor Inhibition and FentanYl Trial
Study Start Date : March 2016
Actual Primary Completion Date : May 25, 2017
Actual Study Completion Date : May 25, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PCI without IV opiate
IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)
Other: Removal of Fentanyl from peri-procedural analgesia
Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI)

Drug: Lidocaine
Local Anesthetic

Drug: Midazolam
IV sedation

Active Comparator: PCI with IV opiate
IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia
Drug: Fentanyl
IV peri-procedural analgesia

Drug: Lidocaine
Local Anesthetic

Drug: Midazolam
IV sedation




Primary Outcome Measures :
  1. Ticagrelor Pharmacokinetics [ Time Frame: Measured over 24 hours (at 0, 0.5, 1, 2, 4, and 24 hours) ]
    Area under the curve for Ticagrelor Absorption


Secondary Outcome Measures :
  1. Single Time-point Platelet Reactivity Using Verify Now [ Time Frame: Measured at 2 hours ]
    Blood test of Platelet Cell Reactivity using Verify Now (P2Y12 Reactivity Units)

  2. Platelet Reactivity Using Light Transmission Aggregometry [ Time Frame: Measured at 2 hours ]
    Blood test of Platelet Cell Reactivity using Light Transmission Aggregometry (reported as percent of baseline aggregation in response to adenosine diphosphate stimulation)

  3. Patient Self-reported Pain [ Time Frame: 2 hours ]
    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".



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683707


Locations
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United States, Maryland
Johns Hopkins Hospital and University School of Medicicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: John W McEvoy, MBBCh MHS Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02683707    
Other Study ID Numbers: IRB00089755
First Posted: February 17, 2016    Key Record Dates
Results First Posted: May 9, 2018
Last Update Posted: June 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Johns Hopkins University:
Percutaneous Coronary Intervention
Blood Platelets
Fentanyl
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Lidocaine
Fentanyl
Midazolam
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Anti-Anxiety Agents