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Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention
During a percutaneous coronary intervention (PCI), Fentanyl is commonly used for sedation. Ticagrelor is also routinely used as anti-platelet agent during PCI. However, a recent study has demonstrated the decrease in effectiveness of Ticagrelor when administered along with Fentanyl. Hence this study was designed to further assess the interaction between crushed vs non crushed Ticagrelor and Fentanyl given during PCI procedures.
Conditions:
🦠 Percutaneous Coronary Intervention
🗓️ Study Start (Actual) 18 April 2018
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 80
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Sayre, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Undergoing clinically indicated elective or non-elective PCI
    • * Able to swallow oral medications

    Exclusion Criteria:

    • * Contraindications to ticagrelor or fentanyl (or other opiates)
    • * Pregnancy
    • * Any use of P2Y12 inhibitors within 14 days
    • * Known coagulation disorders
    • * Pre-procedural treatment with an anticoagulant (oral anticoagulant or low molecular weight heparin)
    • * Platelet count \< 100,000/mm3
    • * Impaired renal function (Estimated glomerular filtration \< 45 ml/min/1.73 m2)
    • * Impaired hepatic function (Based on medical history)
    • * Prior or planned transcatheter aortic valve replacement
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 March 2018
  • First Submitted that Met QC Criteria 23 March 2018
  • First Posted 26 March 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 January 2024
  • Last Update Posted 24 January 2024
  • Last Verified January 2024
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