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Antiplatelet Agent

Fentanyl and Ticagrelor Interaction in Percutaneous Coronary Intervention (FACTPCI Trial)

Phase 4
Recruiting
Research Sponsored by The Guthrie Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Prior or planned transcatheter aortic valve replacement
Pre-procedural treatment with an anticoagulant (oral anticoagulant or low molecular weight heparin)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial suggests that Fentanyl may decrease the effectiveness of Ticagrelor, an anti-platelet agent used during PCI procedures.

Who is the study for?
This trial is for individuals undergoing a heart procedure called PCI and can swallow pills. It's not for pregnant people, those who've taken certain blood thinners recently, have bleeding disorders, low platelets, bad kidney or liver function, or are allergic to the study drugs.
What is being tested?
The study examines how well Ticagrelor works when given in crushed form versus whole tablets during PCI in patients also receiving Fentanyl for sedation. The goal is to see if crushing the pill affects its interaction with Fentanyl.
What are the potential side effects?
Possible side effects include reduced effectiveness of Ticagrelor leading to increased risk of blood clots. Both medications may cause typical drug reactions like nausea or drowsiness; specific risks will be monitored throughout the trial.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had or am scheduled for a valve replacement in my heart via catheter.
Select...
I have been treated with blood thinners before a procedure.
Select...
I cannot take ticagrelor or opiates due to adverse reactions.
Select...
I have a known blood clotting disorder.
Select...
My kidney function is reduced.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Platelet Function Testing

Side effects data

From 2009 Phase 4 trial • 237 Patients • NCT01795898
100%
Aneurysm ruptured
54%
Dizziness
39%
Nausea
26%
Vomiting
16%
Somnolence
5%
Pruritus
2%
Insomnia
2%
Headache
1%
Weakness
1%
Palpitation
1%
Rashes
1%
Chest pain
1%
Cold clammy perspiration
1%
Flushing
1%
Muscle trembling
1%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fentanyl

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Fentanyl and Crushed TicagrelorExperimental Treatment2 Interventions
Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered crushed (180 mg dose)
Group II: Fentanyl and Non-crushed TicagrelorActive Control2 Interventions
Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered as a whole tablet (180 mg dose)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fentanyl
2019
Completed Phase 4
~1920

Find a Location

Who is running the clinical trial?

The Guthrie ClinicLead Sponsor
26 Previous Clinical Trials
1,723 Total Patients Enrolled

Media Library

Ticagrelor (Antiplatelet Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03476369 — Phase 4
Percutaneous Coronary Intervention Research Study Groups: Fentanyl and Crushed Ticagrelor, Fentanyl and Non-crushed Ticagrelor
Percutaneous Coronary Intervention Clinical Trial 2023: Ticagrelor Highlights & Side Effects. Trial Name: NCT03476369 — Phase 4
Ticagrelor (Antiplatelet Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03476369 — Phase 4
~0 spots leftby Dec 2024
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