Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention

Phase 4

Terminated

• Conditions: Percutaneous Coronary Intervention
• Interventions: Drug: Fentanyl; Drug: Ticagrelor 90Mg Tablet

• Registration Number: NCT03476369
• Lead Sponsor: The Guthrie Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-23
• Study First Posted: 2018-03-26
• Study Start: 2018-04-18
• Status Verified: 2025-01
• Primary Completion: 2025-01-23
• Study Completion: 2025-01-23
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl and Crushed Ticagrelor	Fentanyl	Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered crushed (180 mg dose)
Fentanyl and Crushed Ticagrelor	Ticagrelor 90Mg Tablet	Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered crushed (180 mg dose)
Fentanyl and Non-crushed Ticagrelor	Fentanyl	Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered as a whole tablet (180 mg dose)
Fentanyl and Non-crushed Ticagrelor	Ticagrelor 90Mg Tablet	Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered as a whole tablet (180 mg dose)

Primary Outcome Measures

Name	Time	Method
Platelet Function Testing	6 hours	Platelet vasodilator-stimulated phosphoprotein assay

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	30 days
Stent thrombosis	30 days
Recurrent myocardial infarction	30 days
Stroke	30 days
TIMI minor and major	30 days

Trial Locations

Locations (1)

The Guthrie Clinic; 🇺🇸 Sayre, Pennsylvania, United States