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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
Undergoing clinically indicated elective or non-elective PCI
Able to swallow oral medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

FACTPCI Trial 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.Check my eligibility
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.See study design
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.

FACTPCI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a procedure to open blocked arteries in my heart.
Select...
I can take pills by mouth.

FACTPCI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Platelet Function Testing
Secondary outcome measures
All-cause mortality
Recurrent myocardial infarction
Stent thrombosis
+2 more

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

FACTPCI 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
~1870

Find a Location

Who is running the clinical trial?

The Guthrie ClinicLead Sponsor
25 Previous Clinical Trials
1,788 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what cases is Fentanyl typically prescribed to treat?

"Fentanyl is a common anesthetic for conduction, yet can also effectively ease the symptoms of general anesthesia, stent placement, and cerebrovascular accident."

Answered by AI

How many participants have signed up to partake in this research?

"Affirmative. Clinicaltrials.gov displays that this clinical experiment, which was first advertised on April 18th 2018, is currently recruiting patients. 80 individuals are required to be enrolled at 1 medical centre."

Answered by AI

Has the FDA certified Fentanyl for therapeutic use?

"Fentanyl's safety is backed by clinical trials and has been approved, so it was given a score of 3."

Answered by AI

What other experiments have explored the use of Fentanyl in clinical contexts?

"Currently, 83 clinical trials related to Fentanyl are underway with 21 of them in the late-stage. Of these studies, 667 research sites exist and many of them are located in Shenzhen, Guangdong."

Answered by AI

Is participation in this experiment open to new volunteers?

"Clinicaltrials.gov reveals that this clinical trial is actively enrolling patients; the original posting was on April 18th 2018 and it has been edited for the last time on December 14th 2021."

Answered by AI
~8 spots leftby Dec 2024