Percutaneous Coronary Intervention
Conditions
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.
Interventions
DRUGFentanyl
Premedicated with Fentanyl (at least 25mcg by IV)
Ticagrelor administered crushed vs non-crushed
Sponsors
The Guthrie Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Platelet Function Testing (PFT)-Time Curve (AUC0-6) for the First 6 Hours After the Loading Dose of Ticagrelor | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-Day Stroke | 30 days after hospital disharge | Stroke within 30 days after hospital discharge |
| 30-Day TIMI Major and Minor Bleeding | 30 days after hospital discharge | 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. |
| In-Hospital Stent Thrombosis | From time of procedure until hospital discharge, up to 3 days | Stent thrombosis while in hospital from time of procedure until discharge |
| In-Hospital Thrombolysis in Myocardial Infarction (TIMI) Major and Minor Bleeding | From time of procedure until hospital discharge, up to 3 days | 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. |
| In-Hospital Recurrent Myocardial Infarction | From time of procedure until hospital discharge, up to 3 days | Myocardial Infarction while in hospital from time of procedure until discharge |
| In-Hospital Stroke | From time of procedure until hospital discharge, up to 3 days | Stroke while in hospital from time of procedure until discharge |
| In-Hospital Death | From time of procedure until hospital discharge, up to 3 days | Death while in hospital from time of procedure until discharge |
| 30-Day Stent Thrombosis | 30 days after hospital discharge | Stent Thrombosis within 30 days from hospital discharge |
| 30-Day Recurrent Myocardial Infarction | 30 days after hospital discharge | Recurrent myocardial infarction within 30 days after hospital discharge. |
| 30-Day All-cause Mortality (Death) | 30 days after hospital discharge | Death within 30 days after hospital discharge |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 68.50 years STANDARD_DEVIATION 8.84 |
| Body Mass Index (BMI) | 31.93 kilograms per square meter STANDARD_DEVIATION 7.47 |
| Coronary Artery Disease | 25 Participants |
| Diabetes | 8 Participants |
| Gastroesophageal Reflux Disease (GERD) | 12 Participants |
| Hyperlipidemia | 10 Participants |
| Hypertension | 10 Participants |
| Length of Surgery | 1.42 Hours |
| Non-Elective Procedure | 8 Participants |
| Obstructive Sleep Apnea (OSA) | 1 Participants |
| Positive Imaging Study | 19 Participants |
| Primary Procedure Angioplasty Stent Coronary | 37 Participants |
| Prior Myocardial Infarction (MI) at Admission | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 38 participants |
| Renal Insufficiency | 3 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 13 Participants |
| Smoking status = Former/Current Smoker | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 22 |
| other Total, other adverse events | 0 / 16 | 0 / 22 |
| serious Total, serious adverse events | 2 / 16 | 2 / 22 |
Outcome results
None listed