Percutaneous Coronary InterventionPhase 4FACTPCINCT03476369
Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention
A Phase 4 study testing Fentanyl and Ticagrelor 90Mg Tablet in people with Percutaneous Coronary Intervention, run by The Guthrie Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- Fentanyl and Ticagrelor 90Mg Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2018to 23 Jan 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing clinically indicated elective or non-elective PCI
- Able to swallow oral medications
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Percutaneous Coronary Intervention
- Being tested
- Fentanyl, Ticagrelor 90Mg Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Premedicated with Fentanyl (at least 25mcg by IV)
Ticagrelor 90Mg TabletDrug
Ticagrelor administered crushed vs non-crushed
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl and Crushed Ticagrelor | Experimental | Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered crushed (180 mg dose) Receives: Drug: Fentanyl; Drug: Ticagrelor 90Mg Tablet |
| Fentanyl and Non-crushed Ticagrelor | Active comparator | Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered as a whole tablet (180 mg dose) Receives: Drug: Fentanyl; Drug: Ticagrelor 90Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 hours after the loading dose of Ticagrelor
Secondary outcomes (10)
In-Hospital Stent Thrombosis
Stent thrombosis while in hospital from time of procedure until discharge
Measured: 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.
Measured: 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
Measured: From time of procedure until hospital discharge, up to 3 days
In-Hospital Stroke
Stroke while in hospital from time of procedure until discharge
Measured: From time of procedure until hospital discharge, up to 3 days
In-Hospital Death
Death while in hospital from time of procedure until discharge
Measured: From time of procedure until hospital discharge, up to 3 days
30-Day Stent Thrombosis
Stent Thrombosis within 30 days from hospital discharge
Measured: 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.
Measured: 30 days after hospital discharge
30-Day Recurrent Myocardial Infarction
Recurrent myocardial infarction within 30 days after hospital discharge.
Measured: 30 days after hospital discharge
30-Day Stroke
Stroke within 30 days after hospital discharge
Measured: 30 days after hospital disharge
30-Day All-cause Mortality (Death)
Death within 30 days after hospital discharge
Measured: 30 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start18 Apr 2018
- Primary completion23 Jan 2025
- Study completion23 Jan 2025
Why it stopped: Researcher stopped study due to slow accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476369
- Sponsor's protocol ID
- 1801-05
- Acronym
- FACTPCI
- Status last verified
- Jan 2026
- First submitted
- 12 Mar 2018
- Last updated
- 4 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Patients Undergoing Percutaneous Coronary Intervention Who Receive Ticagrelor and Fentanyl
- ClinicalTrials.gov ID
- NCT03476369
- Acronym / sponsor ID
- FACTPCI / 1801-05
- Conditions
- Percutaneous Coronary Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Researcher stopped study due to slow accrual rate
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Posted 4 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl and Crushed Ticagrelor | Experimental | Drug: Fentanyl, Drug: Ticagrelor 90Mg TabletPremedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered crushed (180 mg dose) |
| Fentanyl and Non-crushed Ticagrelor | Active comparator | Drug: Fentanyl, Drug: Ticagrelor 90Mg TabletPremedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered as a whole tablet (180 mg dose) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing clinically indicated elective or non-elective PCI
- Able to swallow oral medications
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylPremedicated with Fentanyl (at least 25mcg by IV) | Drug | Fentanyl and Crushed Ticagrelor, Fentanyl and Non-crushed Ticagrelor |
| Ticagrelor 90Mg TabletTicagrelor administered crushed vs non-crushed | Drug | Fentanyl and Crushed Ticagrelor, Fentanyl and Non-crushed Ticagrelor |
Primary outcome
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
10 secondary outcomes
In-Hospital Stent Thrombosis
Time frame: 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
In-Hospital Recurrent Myocardial Infarction
Time frame: 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
In-Hospital Death
Time frame: From time of procedure until hospital discharge, up to 3 days
30-Day Stent Thrombosis
Time frame: 30 days after hospital discharge
30-Day TIMI Major and Minor Bleeding
Time frame: 30 days after hospital discharge
30-Day Recurrent Myocardial Infarction
Time frame: 30 days after hospital discharge
30-Day Stroke
Time frame: 30 days after hospital disharge
30-Day All-cause Mortality (Death)
Time frame: 30 days after hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl and Ticagrelor 90Mg Tablet in people with Percutaneous Coronary Intervention, run by The Guthrie Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.