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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03476369
Other study ID # 1801-05
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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