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Researcher stopped study due to slow accrual rate
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl and Crushed Ticagrelor | Experimental | Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered crushed (180 mg dose) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | Premedicated with Fentanyl (at least 25mcg by IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| In-Hospital Stent Thrombosis | Stent thrombosis while in hospital from time of procedure until discharge | From time of procedure until hospital discharge, up to 3 days |
| In-Hospital Thrombolysis in Myocardial Infarction (TIMI) Major and Minor Bleeding |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Time (Hours) in the hospital from admission for the procedure until discharge | From admission for the procedure until discharge, assessed up to 3 days |
| 30-Day Hospital Readmission |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Guthrie Clinic | Sayre | Pennsylvania | 18840 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fentanyl and Crushed Ticagrelor | Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered crushed (180 mg dose) Fentanyl: Premedicated with Fentanyl (at least 25mcg by IV) Ticagrelor 90Mg Tablet: Ticagrelor administered crushed vs non-crushed |
| FG001 | Fentanyl and Non-crushed Ticagrelor | Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered as a whole tablet (180 mg dose) Fentanyl: Premedicated with Fentanyl (at least 25mcg by IV) Ticagrelor 90Mg Tablet: Ticagrelor administered crushed vs non-crushed |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fentanyl and Crushed Ticagrelor | Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered crushed (180 mg dose) Fentanyl: Premedicated with Fentanyl (at least 25mcg by IV) Ticagrelor 90Mg Tablet: Ticagrelor administered crushed vs non-crushed |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Not all participants had a test completed at every time. | Posted | Median | Inter-Quartile Range | Platelet Reactive Units (PRUs)/hour | 6 hours after the loading dose of Ticagrelor |
|
30 days after hospital discharge
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fentanyl and Crushed Ticagrelor | Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered crushed (180 mg dose) Fentanyl: Premedicated with Fentanyl (at least 25mcg by IV) Ticagrelor 90Mg Tablet: Ticagrelor administered crushed vs non-crushed |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stent Thrombosis | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sudhakar Sattur MD, Principal Investigator | The Guthrie Clinic | 570-887-4882 | Sudhakar.Sattur@guthrie.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 28, 2019 | Dec 23, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 10, 2025 | Dec 23, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D000077486 | Ticagrelor |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000241 | Adenosine |
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| Ticagrelor 90Mg Tablet | Drug | Ticagrelor administered crushed vs non-crushed |
|
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.
| 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 | From time of procedure until hospital discharge, up to 3 days |
| In-Hospital Stroke | Stroke while in hospital from time of procedure until discharge | From time of procedure until hospital discharge, up to 3 days |
| In-Hospital Death | Death while in hospital from time of procedure until discharge | From time of procedure until hospital discharge, up to 3 days |
| 30-Day Stent Thrombosis | Stent Thrombosis within 30 days from hospital discharge | 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. | 30 days after hospital discharge |
| 30-Day Recurrent Myocardial Infarction | Recurrent myocardial infarction within 30 days after hospital discharge. | 30 days after hospital discharge |
| 30-Day Stroke | Stroke within 30 days after hospital discharge | 30 days after hospital disharge |
| 30-Day All-cause Mortality (Death) | Death within 30 days after hospital discharge | 30 days after hospital discharge |
Readmission to the hospital within 30 days of discharge
| 30 days after hospital discharge |
| Fentanyl and Non-crushed Ticagrelor |
Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered as a whole tablet (180 mg dose) Fentanyl: Premedicated with Fentanyl (at least 25mcg by IV) Ticagrelor 90Mg Tablet: Ticagrelor administered crushed vs non-crushed |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms per square meter |
|
| Smoking status = Former/Current Smoker | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Hyperlipidemia | Count of Participants | Participants |
|
| Coronary Artery Disease | Count of Participants | Participants |
|
| Gastroesophageal Reflux Disease (GERD) | Count of Participants | Participants |
|
| Obstructive Sleep Apnea (OSA) | Count of Participants | Participants |
|
| Positive Imaging Study | Imaging tests check blood flow to the heart. A positive imaging study shows signs of reduced blood flow or blockages that may cause chest pain or heart attacks. Common tests include stress ultrasound, blood flow scans, CT artery scans, and measurements during heart procedures. These tests help doctors decide if treatment is needed. | Count of Participants | Participants |
|
| Prior Myocardial Infarction (MI) at Admission | Count of Participants | Participants |
|
| Renal Insufficiency | Count of Participants | Participants |
|
| Non-Elective Procedure | Percutaneous coronary intervention (PCI) is a procedure used to open blocked or narrowed heart arteries using catheters and related devices. A non-elective procedure is a procedure that was not planned in advance and was performed urgently or as an emergency based on the patient's condition. Patients were classified as non-elective if the procedure was performed due to acute symptoms or findings such as ongoing chest pain, heart attack, unstable angina, or other evidence of reduced blood flow to the heart requiring prompt treatment. | Count of Participants | Participants |
|
| Primary Procedure Angioplasty Stent Coronary | Count of Participants | Participants |
|
| Length of Surgery | Median | Inter-Quartile Range | Hours |
|
| OG001 | Fentanyl and Non-crushed Ticagrelor | Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered as a whole tablet (180 mg dose) Fentanyl: Premedicated with Fentanyl (at least 25mcg by IV) Ticagrelor 90Mg Tablet: Ticagrelor administered crushed vs non-crushed |
|
|
| Secondary | In-Hospital Stent Thrombosis | Stent thrombosis while in hospital from time of procedure until discharge | Posted | Count of Participants | Participants | From time of procedure until hospital discharge, up to 3 days |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | From time of procedure until hospital discharge, up to 3 days |
|
|
|
| Secondary | In-Hospital Recurrent Myocardial Infarction | Myocardial Infarction while in hospital from time of procedure until discharge | Posted | Count of Participants | Participants | From time of procedure until hospital discharge, up to 3 days |
|
|
|
| Secondary | In-Hospital Stroke | Stroke while in hospital from time of procedure until discharge | Posted | Count of Participants | Participants | From time of procedure until hospital discharge, up to 3 days |
|
|
|
| Secondary | In-Hospital Death | Death while in hospital from time of procedure until discharge | Posted | Count of Participants | Participants | From time of procedure until hospital discharge, up to 3 days |
|
|
|
| Secondary | 30-Day Stent Thrombosis | Stent Thrombosis within 30 days from hospital discharge | Posted | Count of Participants | Participants | 30 days after hospital discharge |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 30 days after hospital discharge |
|
|
|
| Secondary | 30-Day Recurrent Myocardial Infarction | Recurrent myocardial infarction within 30 days after hospital discharge. | Posted | Count of Participants | Participants | 30 days after hospital discharge |
|
|
|
| Secondary | 30-Day Stroke | Stroke within 30 days after hospital discharge | Posted | Count of Participants | Participants | 30 days after hospital disharge |
|
|
|
| Secondary | 30-Day All-cause Mortality (Death) | Death within 30 days after hospital discharge | Posted | Count of Participants | Participants | 30 days after hospital discharge |
|
|
|
| Other Pre-specified | Hospital Length of Stay | Time (Hours) in the hospital from admission for the procedure until discharge | Posted | Median | Inter-Quartile Range | Hours | From admission for the procedure until discharge, assessed up to 3 days |
|
|
|
| Other Pre-specified | 30-Day Hospital Readmission | Readmission to the hospital within 30 days of discharge | Posted | Count of Participants | Participants | 30 days after hospital discharge |
|
|
|
| 0 |
| 16 |
| 2 |
| 16 |
| 0 |
| 16 |
| EG001 | Fentanyl and Non-crushed Ticagrelor | Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered as a whole tablet (180 mg dose) Fentanyl: Premedicated with Fentanyl (at least 25mcg by IV) Ticagrelor 90Mg Tablet: Ticagrelor administered crushed vs non-crushed | 0 | 22 | 2 | 22 | 0 | 22 |
| TIMI bleeding | Blood and lymphatic system disorders | Systematic Assessment | TIMI bleeding is standardized classification to grade bleeding severity in cardiovascular studies. The measure will assess any participant who had at least a 3 g/dL drop in hemoglobin. |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
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| D011684 |
| Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |