Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention

Percutaneous Coronary Intervention Clinical Trial

— FACTPCI  

Official title:

A Randomized Controlled Trial of Patients Undergoing Percutaneous Coronary Intervention Who Receive Ticagrelor and Fentanyl

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03476369
• Other study ID #: 1801-05
• Status: Recruiting
• Phase: Phase 4
• Start date: April 18, 2018
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: The Guthrie Clinic
• Contact: Sudhakar Sattur, MD
• Phone: 570-887-6072
• Email: Sudhakar.Sattur[@]guthrie.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Hence this study was designed to further assess the interaction between crushed vs non crushed Ticagrelor and Fentanyl given during PCI procedures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Intervention

Drug:
• Fentanyl
Premedicated with Fentanyl (at least 25mcg by IV)
• Ticagrelor 90Mg Tablet
Ticagrelor administered crushed vs non-crushed

Locations

Country	Name	City	State
United States	The Guthrie Clinic	Sayre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
The Guthrie Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet Function Testing	Platelet vasodilator-stimulated phosphoprotein assay	6 hours
Secondary	Stent thrombosis		30 days
Secondary	Recurrent myocardial infarction		30 days
Secondary	All-cause mortality		30 days
Secondary	Stroke		30 days
Secondary	TIMI minor and major		30 days