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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Premedicated with Fentanyl (at least 25mcg by IV)
Ticagrelor administered crushed vs non-crushed
The Guthrie Clinic
Sayre, Pennsylvania, United States
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
Time frame: 6 hours after the loading dose of Ticagrelor
In-Hospital Stent Thrombosis
Stent thrombosis while in hospital from time of procedure until discharge
Time frame: From time of procedure until hospital discharge, up to 3 days
In-Hospital Thrombolysis in Myocardial Infarction (TIMI) Major and Minor Bleeding
TIMI bleeding is a standardized clinical trial classification used to grade bleeding severity in cardiovascular studies. TIMI major bleeding: Any intracranial hemorrhage, or clinically overt bleeding with a ≥5 g/dL decrease in hemoglobin (or ≥15% absolute drop in hematocrit). TIMI minor bleeding: Clinically overt bleeding associated with a 3 to \<5 g/dL decrease in hemoglobin (or 10 to \<15% absolute drop in hematocrit). The measure will assess any participant who had at least a 3 g/dL drop in hemoglobin.
Time frame: From time of procedure until hospital discharge, up to 3 days
In-Hospital Recurrent Myocardial Infarction
Myocardial Infarction while in hospital from time of procedure until discharge
Time frame: From time of procedure until hospital discharge, up to 3 days
In-Hospital Stroke
Stroke while in hospital from time of procedure until discharge
Time frame: From time of procedure until hospital discharge, up to 3 days
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In-Hospital Death
Death while in hospital from time of procedure until discharge
Time frame: From time of procedure until hospital discharge, up to 3 days
30-Day Stent Thrombosis
Stent Thrombosis within 30 days from hospital discharge
Time frame: 30 days after hospital discharge
30-Day TIMI Major and Minor Bleeding
TIMI bleeding is a standardized clinical trial classification used to grade bleeding severity in cardiovascular studies. TIMI major bleeding: Any intracranial hemorrhage, or clinically overt bleeding with a ≥5 g/dL decrease in hemoglobin (or ≥15% absolute drop in hematocrit). TIMI minor bleeding: Clinically overt bleeding associated with a 3 to \<5 g/dL decrease in hemoglobin (or 10 to \<15% absolute drop in hematocrit). The measure will assess any participant who had at least a 3 g/dL drop in hemoglobin.
Time frame: 30 days after hospital discharge
30-Day Recurrent Myocardial Infarction
Recurrent myocardial infarction within 30 days after hospital discharge.
Time frame: 30 days after hospital discharge
30-Day Stroke
Stroke within 30 days after hospital discharge
Time frame: 30 days after hospital disharge
30-Day All-cause Mortality (Death)
Death within 30 days after hospital discharge
Time frame: 30 days after hospital discharge