Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention

NCT03476369 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 1801-05
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Area Under the Platelet Function Testing (PFT)-Time Curve (AUC0-6) for the First 6 Hours After the Loading Dose of Ticagrelor

  The Platelet Function Testing assay will be VerifyNow Platelet Reactivity Assay which is used institutionally. Results are reported in platelet reactive units (PRUs). Based on previous studies, 208 will be used as an estimated cutoff to distinguish therapeutic and subtherapeutic platelet inhibition, with PRUs equal to or less than 208 being considered therapeutic

  6 hours after the loading dose of Ticagrelor

Secondary Outcomes (10)

• In-Hospital Stent Thrombosis

  From time of procedure until hospital discharge, up to 3 days

• In-Hospital Thrombolysis in Myocardial Infarction (TIMI) Major and Minor Bleeding

  From time of procedure until hospital discharge, up to 3 days

• In-Hospital Recurrent Myocardial Infarction

  From time of procedure until hospital discharge, up to 3 days

• In-Hospital Stroke

  From time of procedure until hospital discharge, up to 3 days

• In-Hospital Death

  From time of procedure until hospital discharge, up to 3 days

Other Outcomes (2)

• Hospital Length of Stay

  From admission for the procedure until discharge, assessed up to 3 days

• 30-Day Hospital Readmission

  30 days after hospital discharge

Study Arms (2)

Fentanyl and Crushed Ticagrelor

EXPERIMENTAL

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

Drug: Fentanyl; Drug: Ticagrelor 90Mg Tablet

Fentanyl and Non-crushed Ticagrelor

ACTIVE COMPARATOR

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

Drug: Fentanyl; Drug: Ticagrelor 90Mg Tablet

Interventions

Fentanyl DRUG

Premedicated with Fentanyl (at least 25mcg by IV)

Fentanyl and Crushed Ticagrelor; Fentanyl and Non-crushed Ticagrelor

Ticagrelor 90Mg Tablet DRUG

Ticagrelor administered crushed vs non-crushed

Fentanyl and Crushed Ticagrelor; Fentanyl and Non-crushed Ticagrelor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing clinically indicated elective or non-elective PCI
• Able to swallow oral medications

You may not qualify if:

• 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

Sponsors & Collaborators

• The Guthrie Clinic: lead

Study Sites (1)

The Guthrie Clinic

Sayre, Pennsylvania, 18840, United States

Location

MeSH Terms

Interventions

Fentanyl; Ticagrelor; Tablets

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Sudhakar Sattur MD, Principal Investigator
• Organization: The Guthrie Clinic

Sudhakar.Sattur@guthrie.org

570-887-4882

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 26, 2018
• Study Start: April 18, 2018
• Primary Completion: January 23, 2025
• Study Completion: January 23, 2025
• Last Updated: February 4, 2026
• Results First Posted: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)