Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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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.

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

Conditions
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Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: Fentanyl
* Drug: Ticagrelor 90Mg Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fentanyl and Crushed Ticagrelor<br>Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered crushed (180 mg dose) | Drug: Fentanyl<br>* Premedicated with Fentanyl (at least 25mcg by IV)<br>Drug: Ticagrelor 90Mg Tablet<br>* Ticagrelor administered crushed vs non-crushed<br>|
| Active Comparator: Fentanyl and Non-crushed Ticagrelor<br>Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered as a whole tablet (180 mg dose) | Drug: Fentanyl<br>* Premedicated with Fentanyl (at least 25mcg by IV)<br>Drug: Ticagrelor 90Mg Tablet<br>* Ticagrelor administered crushed vs non-crushed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet Function Testing | Platelet vasodilator-stimulated phosphoprotein assay | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent thrombosis |  | 30 days | 
| Recurrent myocardial infarction |  | 30 days | 
| All-cause mortality |  | 30 days | 
| Stroke |  | 30 days | 
| TIMI minor and major |  | 30 days |