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Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention (FACTPCI)

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ClinicalTrials.gov Identifier: NCT03476369
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
The Guthrie Clinic

Tracking Information
First Submitted Date  ICMJE March 12, 2018
First Posted Date  ICMJE March 26, 2018
Last Update Posted Date April 18, 2019
Actual Study Start Date  ICMJE April 18, 2018
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2018)
Platelet Function Testing [ Time Frame: 12 hours ]
Platelet vasodilator-stimulated phosphoprotein assay
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03476369 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2018)
  • Stent thrombosis [ Time Frame: 30 days ]
  • Recurrent myocardial infarction [ Time Frame: 30 days ]
  • All-cause mortality [ Time Frame: 30 days ]
  • Stroke [ Time Frame: 30 days ]
  • TIMI minor and major [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention
Official Title  ICMJE A Randomized Controlled Trial of Patients Undergoing Percutaneous Coronary Intervention Who Receive Ticagrelor and Fentanyl
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Percutaneous Coronary Intervention
Intervention  ICMJE
  • Drug: Fentanyl
    Premedicated with Fentanyl (at least 25mcg by IV)
  • Drug: Ticagrelor 90Mg Tablet
    Ticagrelor administered crushed vs non-crushed
Study Arms  ICMJE
  • Experimental: Fentanyl and Crushed Ticagrelor
    Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered crushed (180 mg dose)
    Interventions:
    • Drug: Fentanyl
    • Drug: Ticagrelor 90Mg Tablet
  • Active Comparator: Fentanyl and Non-crushed Ticagrelor
    Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered as a whole tablet (180 mg dose)
    Interventions:
    • Drug: Fentanyl
    • Drug: Ticagrelor 90Mg Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sudhakar Sattur, MD 570-887-6072 Sudhakar.Sattur@guthrie.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03476369
Other Study ID Numbers  ICMJE 1801-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The Guthrie Clinic
Study Sponsor  ICMJE The Guthrie Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Guthrie Clinic
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP