Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention (FACTPCI)

January 20, 2026 updated by: The Guthrie Clinic

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
In-Hospital Stent Thrombosis
Time Frame: From time of procedure until hospital discharge, up to 3 days
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
Time Frame: From time of procedure until hospital discharge, up to 3 days

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
Time Frame: From time of procedure until hospital discharge, up to 3 days
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
Time Frame: From time of procedure until hospital discharge, up to 3 days
Stroke while in hospital from time of procedure until discharge
From time of procedure until hospital discharge, up to 3 days
In-Hospital Death
Time Frame: From time of procedure until hospital discharge, up to 3 days
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
Time Frame: 30 days after hospital discharge
Stent Thrombosis within 30 days from hospital discharge
30 days after hospital discharge
30-Day TIMI Major and Minor Bleeding
Time Frame: 30 days after hospital discharge

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
Time Frame: 30 days after hospital discharge
Recurrent myocardial infarction within 30 days after hospital discharge.
30 days after hospital discharge
30-Day Stroke
Time Frame: 30 days after hospital disharge
Stroke within 30 days after hospital discharge
30 days after hospital disharge
30-Day All-cause Mortality (Death)
Time Frame: 30 days after hospital discharge
Death within 30 days after hospital discharge
30 days after hospital discharge

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital Length of Stay
Time Frame: From admission for the procedure until discharge, assessed up to 3 days
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
Time Frame: 30 days after hospital discharge
Readmission to the hospital within 30 days of discharge
30 days after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Guthrie Clinic

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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