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TerminatedNCT03476369FACTPCIUpdated Feb 4, 2026Results posted

Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention

A Phase 4 interventional study of Fentanyl and Ticagrelor 90Mg Tablet in Percutaneous Coronary Intervention, sponsored by The Guthrie Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-04.

Sponsored by The Guthrie Clinic · Phase 4, Interventional, and Treatment

Why this study was terminated
Researcher stopped study due to slow accrual rate
Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Percutaneous Coronary Intervention
03

In context

Lead sponsor

The Guthrie Clinic is the lead sponsor of 26 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • 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 · 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)

    Drug: Fentanyl · Drug: Ticagrelor 90Mg Tablet

Interventions

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 hours after the loading dose of Ticagrelor

Secondary outcomes

  1. In-Hospital Stent Thrombosis

    Stent thrombosis while in hospital from time of procedure until discharge

    Time frame: From time of procedure until hospital discharge, up to 3 days

  2. 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.

    Time frame: From time of procedure until hospital discharge, up to 3 days

  3. In-Hospital Recurrent Myocardial Infarction

    Myocardial Infarction while in hospital from time of procedure until discharge

    Time frame: From time of procedure until hospital discharge, up to 3 days

  4. In-Hospital Stroke

    Stroke while in hospital from time of procedure until discharge

    Time frame: From time of procedure until hospital discharge, up to 3 days

  5. In-Hospital Death

    Death while in hospital from time of procedure until discharge

    Time frame: From time of procedure until hospital discharge, up to 3 days

  6. 30-Day Stent Thrombosis

    Stent Thrombosis within 30 days from hospital discharge

    Time frame: 30 days after hospital discharge

  7. 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.

    Time frame: 30 days after hospital discharge

  8. 30-Day Recurrent Myocardial Infarction

    Recurrent myocardial infarction within 30 days after hospital discharge.

    Time frame: 30 days after hospital discharge

  9. 30-Day Stroke

    Stroke within 30 days after hospital discharge

    Time frame: 30 days after hospital disharge

  10. 30-Day All-cause Mortality (Death)

    Death within 30 days after hospital discharge

    Time frame: 30 days after hospital discharge

Other outcomes

  1. Hospital Length of Stay

    Time (Hours) in the hospital from admission for the procedure until discharge

    Time frame: From admission for the procedure until discharge, assessed up to 3 days

  2. 30-Day Hospital Readmission

    Readmission to the hospital within 30 days of discharge

    Time frame: 30 days after hospital discharge

07

Results

Posted Feb 4, 2026

Participant flow

Participant flow — Overall Study
MilestoneFentanyl and Crushed TicagrelorFentanyl and Non-crushed Ticagrelor
Started2025
Completed1622
Not completed43

Outcome measures

PrimaryArea 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

Time frame:
6 hours after the loading dose of Ticagrelor
Reported as:
Median · Platelet Reactive Units (PRUs)/hour
Area Under the Platelet Function Testing (PFT)-Time Curve (AUC0-6) for the First 6 Hours After the Loading Dose of Ticagrelor
Platelet Reactive Units (PRUs)/hourFentanyl and Crushed TicagrelorFentanyl and Non-crushed Ticagrelor
Area Under the Platelet Function Testing (PFT)-Time Curve (AUC0-6) for the First 6 Hours After the Loading Dose of Ticagrelor796.34 (420.23 to 950.36)622.37 (439.28 to 712.04)
SecondaryIn-Hospital Stent Thrombosis

Stent thrombosis while in hospital from time of procedure until discharge

Time frame:
From time of procedure until hospital discharge, up to 3 days
Reported as:
Count of participants · Participants
In-Hospital Stent Thrombosis
ParticipantsFentanyl and Crushed TicagrelorFentanyl and Non-crushed Ticagrelor
In-Hospital Stent Thrombosis00
SecondaryIn-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.

Time frame:
From time of procedure until hospital discharge, up to 3 days
Reported as:
Count of participants · Participants
In-Hospital Thrombolysis in Myocardial Infarction (TIMI) Major and Minor Bleeding
ParticipantsFentanyl and Crushed TicagrelorFentanyl and Non-crushed Ticagrelor
In-Hospital Thrombolysis in Myocardial Infarction (TIMI) Major and Minor Bleeding00
SecondaryIn-Hospital Recurrent Myocardial Infarction

Myocardial Infarction while in hospital from time of procedure until discharge

Time frame:
From time of procedure until hospital discharge, up to 3 days
Reported as:
Count of participants · Participants
In-Hospital Recurrent Myocardial Infarction
ParticipantsFentanyl and Crushed TicagrelorFentanyl and Non-crushed Ticagrelor
In-Hospital Recurrent Myocardial Infarction00
SecondaryIn-Hospital Stroke

Stroke while in hospital from time of procedure until discharge

Time frame:
From time of procedure until hospital discharge, up to 3 days
Reported as:
Count of participants · Participants
In-Hospital Stroke
ParticipantsFentanyl and Crushed TicagrelorFentanyl and Non-crushed Ticagrelor
In-Hospital Stroke00
SecondaryIn-Hospital Death

Death while in hospital from time of procedure until discharge

Time frame:
From time of procedure until hospital discharge, up to 3 days
Reported as:
Count of participants · Participants
In-Hospital Death
ParticipantsFentanyl and Crushed TicagrelorFentanyl and Non-crushed Ticagrelor
In-Hospital Death00
Secondary30-Day Stent Thrombosis

Stent Thrombosis within 30 days from hospital discharge

Time frame:
30 days after hospital discharge
Reported as:
Count of participants · Participants
30-Day Stent Thrombosis
ParticipantsFentanyl and Crushed TicagrelorFentanyl and Non-crushed Ticagrelor
30-Day Stent Thrombosis10
Secondary30-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.

Time frame:
30 days after hospital discharge
Reported as:
Count of participants · Participants
30-Day TIMI Major and Minor Bleeding
ParticipantsFentanyl and Crushed TicagrelorFentanyl and Non-crushed Ticagrelor
30-Day TIMI Major and Minor Bleeding00
Secondary30-Day Recurrent Myocardial Infarction

Recurrent myocardial infarction within 30 days after hospital discharge.

Time frame:
30 days after hospital discharge
Reported as:
Count of participants · Participants
30-Day Recurrent Myocardial Infarction
ParticipantsFentanyl and Crushed TicagrelorFentanyl and Non-crushed Ticagrelor
30-Day Recurrent Myocardial Infarction12
Secondary30-Day Stroke

Stroke within 30 days after hospital discharge

Time frame:
30 days after hospital disharge
Reported as:
Count of participants · Participants
30-Day Stroke
ParticipantsFentanyl and Crushed TicagrelorFentanyl and Non-crushed Ticagrelor
30-Day Stroke00
Secondary30-Day All-cause Mortality (Death)

Death within 30 days after hospital discharge

Time frame:
30 days after hospital discharge
Reported as:
Count of participants · Participants
30-Day All-cause Mortality (Death)
ParticipantsFentanyl and Crushed TicagrelorFentanyl and Non-crushed Ticagrelor
30-Day All-cause Mortality (Death)00
Other pre-specifiedHospital Length of Stay

Time (Hours) in the hospital from admission for the procedure until discharge

Time frame:
From admission for the procedure until discharge, assessed up to 3 days
Reported as:
Median · Hours
Hospital Length of Stay
HoursFentanyl and Crushed TicagrelorFentanyl and Non-crushed Ticagrelor
Hospital Length of Stay27.00 (23.00 to 40.00)28.50 (22.25 to 48.75)
Other pre-specified30-Day Hospital Readmission

Readmission to the hospital within 30 days of discharge

Time frame:
30 days after hospital discharge
Reported as:
Count of participants · Participants
30-Day Hospital Readmission
ParticipantsFentanyl and Crushed TicagrelorFentanyl and Non-crushed Ticagrelor
30-Day Hospital Readmission01

Adverse events

Collected over 30 days after hospital discharge. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fentanyl and Crushed Ticagrelor0/16 (0%)2/16 (12.5%)0/16 (0%)
Fentanyl and Non-crushed Ticagrelor0/22 (0%)2/22 (9.1%)0/22 (0%)
Most frequent serious events
Most frequent serious events
EventFentanyl and Crushed TicagrelorFentanyl and Non-crushed Ticagrelor
Myocardial InfarctionCardiac disorders1/162/22
Stent ThrombosisCardiac disorders1/160/22
TIMI bleedingBlood and lymphatic system disorders0/160/22
StrokeNervous system disorders0/160/22

Baseline characteristics

Age, Continuous
Age, Continuous(years)Fentanyl and Crushed TicagrelorFentanyl and Non-crushed TicagrelorTotal
Mean65.19 ± 9.5868.50 ± 8.8467.11 ± 9.18
Sex: Female, Male
Sex: Female, Male(Participants)Fentanyl and Crushed TicagrelorFentanyl and Non-crushed TicagrelorTotal
Female369
Male131629
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Fentanyl and Crushed TicagrelorFentanyl and Non-crushed TicagrelorTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American101
White152237
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Fentanyl and Crushed TicagrelorFentanyl and Non-crushed TicagrelorTotal
United States162238
Body Mass Index (BMI)
Body Mass Index (BMI)(kilograms per square meter)Fentanyl and Crushed TicagrelorFentanyl and Non-crushed TicagrelorTotal
Mean31.93 ± 7.4731.68 ± 5.7631.79 ± 6.43
Smoking status = Former/Current Smoker
Smoking status = Former/Current Smoker(Participants)Fentanyl and Crushed TicagrelorFentanyl and Non-crushed TicagrelorTotal
Count of participants131326
Diabetes
Diabetes(Participants)Fentanyl and Crushed TicagrelorFentanyl and Non-crushed TicagrelorTotal
Count of participants8917
Hypertension
Hypertension(Participants)Fentanyl and Crushed TicagrelorFentanyl and Non-crushed TicagrelorTotal
Count of participants101828

10 further baseline measures are reported on the registry.

08

Study locations

1 site
  • The Guthrie Clinic
    Sayre, Pennsylvania 18840, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2018 to primary completion in Jan 2025, 81 months.

Results were first posted in Feb 2026, 1 year after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2018
First posted
Mar 26, 2018
StartActual
Apr 18, 2018
Primary completionActual
Jan 23, 2025
CompletionActual
Jan 23, 2025
Results first posted
Feb 4, 2026
Last update
Feb 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03476369
Lead sponsor
The Guthrie Clinic
Responsible party
Sponsor
First posted
Mar 26, 2018
Start date
Apr 18, 2018
Primary completion
Jan 23, 2025
Completion
Jan 23, 2025
Results posted
Feb 4, 2026
Last update
Feb 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Fentanyl · Ticagrelor

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