The Platelet Aggregation After tiCagrelor Inhibition and FentanYl Trial (PACIFY)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Removal of Fentanyl from peri-procedural analgesia; Fentanyl; Lidocaine; Midazolam
Intervention description: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI); IV peri-procedural analgesia; Local Anesthetic; IV sedation
Intervention MeSH terms: Lidocaine; Midazolam; Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 212.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Percutaneous Coronary Intervention; Blood Platelets; Fentanyl

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.
    

Eligibility 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.