Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention (FACTPCI)

A Randomized Controlled Trial of Patients Undergoing Percutaneous Coronary Intervention Who Receive Ticagrelor and Fentanyl

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.

Study Overview

• Status: Terminated
• Conditions: Percutaneous Coronary Intervention
• Intervention / Treatment: Drug: Fentanyl; Drug: Ticagrelor 90Mg Tablet

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • The Guthrie Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fentanyl and Crushed Ticagrelor; Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered crushed (180 mg dose)	Drug: Fentanyl; Premedicated with Fentanyl (at least 25mcg by IV); Drug: Ticagrelor 90Mg Tablet; Ticagrelor administered crushed vs non-crushed
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)	Drug: Fentanyl; Premedicated with Fentanyl (at least 25mcg by IV); Drug: Ticagrelor 90Mg Tablet; Ticagrelor administered crushed vs non-crushed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Platelet Function Testing (PFT)-Time Curve (AUC0-6) for the First 6 Hours After the Loading Dose of Ticagrelor	The Platelet Function Testing assay will be VerifyNow Platelet Reactivity Assay which is used institutionally. Results are reported in platelet reactive units (PRUs). Based on previous studies, 208 will be used as an estimated cutoff to distinguish therapeutic and subtherapeutic platelet inhibition, with PRUs equal to or less than 208 being considered therapeutic	6 hours after the loading dose of Ticagrelor

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-Hospital Stent Thrombosis	Stent thrombosis while in hospital from time of procedure until discharge	From time of procedure until hospital discharge, up to 3 days
In-Hospital Thrombolysis in Myocardial Infarction (TIMI) Major and Minor Bleeding	TIMI bleeding is a standardized clinical trial classification used to grade bleeding severity in cardiovascular studies. TIMI major bleeding: Any intracranial hemorrhage, or clinically overt bleeding with a ≥5 g/dL decrease in hemoglobin (or ≥15% absolute drop in hematocrit). TIMI minor bleeding: Clinically overt bleeding associated with a 3 to <5 g/dL decrease in hemoglobin (or 10 to <15% absolute drop in hematocrit). The measure will assess any participant who had at least a 3 g/dL drop in hemoglobin.	From time of procedure until hospital discharge, up to 3 days
In-Hospital Recurrent Myocardial Infarction	Myocardial Infarction while in hospital from time of procedure until discharge	From time of procedure until hospital discharge, up to 3 days
In-Hospital Stroke	Stroke while in hospital from time of procedure until discharge	From time of procedure until hospital discharge, up to 3 days
In-Hospital Death	Death while in hospital from time of procedure until discharge	From time of procedure until hospital discharge, up to 3 days
30-Day Stent Thrombosis	Stent Thrombosis within 30 days from hospital discharge	30 days after hospital discharge
30-Day TIMI Major and Minor Bleeding	TIMI bleeding is a standardized clinical trial classification used to grade bleeding severity in cardiovascular studies. TIMI major bleeding: Any intracranial hemorrhage, or clinically overt bleeding with a ≥5 g/dL decrease in hemoglobin (or ≥15% absolute drop in hematocrit). TIMI minor bleeding: Clinically overt bleeding associated with a 3 to <5 g/dL decrease in hemoglobin (or 10 to <15% absolute drop in hematocrit). The measure will assess any participant who had at least a 3 g/dL drop in hemoglobin.	30 days after hospital discharge
30-Day Recurrent Myocardial Infarction	Recurrent myocardial infarction within 30 days after hospital discharge.	30 days after hospital discharge
30-Day Stroke	Stroke within 30 days after hospital discharge	30 days after hospital disharge
30-Day All-cause Mortality (Death)	Death within 30 days after hospital discharge	30 days after hospital discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay	Time (Hours) in the hospital from admission for the procedure until discharge	From admission for the procedure until discharge, assessed up to 3 days
30-Day Hospital Readmission	Readmission to the hospital within 30 days of discharge	30 days after hospital discharge

Collaborators and Investigators

• Sponsor: The Guthrie Clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2018
• Primary Completion (Actual): January 23, 2025
• Study Completion (Actual): January 23, 2025

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Dosage Forms; Nucleic Acids, Nucleotides, and Nucleosides; Piperidines; Purines; Nucleosides; Ribonucleosides; Adenosine; Purine Nucleosides; Ticagrelor; Fentanyl; Tablets
• Other Study ID Numbers: 1801-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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