Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention (FACTPCI)

The Guthrie Clinic

Status and phase: Terminated; Phase 4

Conditions: Percutaneous Coronary Intervention

Treatments: Drug: Fentanyl; Drug: Ticagrelor 90Mg Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03476369

1801-05

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Fentanyl and Crushed Ticagrelor

Experimental group

Description:

Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered crushed (180 mg dose)

Treatment:

Drug: Ticagrelor 90Mg Tablet

Drug: Fentanyl

Fentanyl and Non-crushed Ticagrelor

Active Comparator group

Description:

Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered as a whole tablet (180 mg dose)

Treatment:

Drug: Ticagrelor 90Mg Tablet

Drug: Fentanyl