Trial Outcomes & Findings for Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention (NCT NCT03476369)
NCT ID: NCT03476369
Last Updated: 2026-02-04
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
45 participants
Primary outcome timeframe
6 hours after the loading dose of Ticagrelor
Results posted on
2026-02-04
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
25
|
|
Overall Study
COMPLETED
|
16
|
22
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention
Baseline characteristics by cohort
| Measure |
Fentanyl and Crushed Ticagrelor
n=16 Participants
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
|
Fentanyl and Non-crushed Ticagrelor
n=22 Participants
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
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.19 years
STANDARD_DEVIATION 9.58 • n=25 Participants
|
68.50 years
STANDARD_DEVIATION 8.84 • n=26 Participants
|
67.11 years
STANDARD_DEVIATION 9.18 • n=51 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=25 Participants
|
6 Participants
n=26 Participants
|
9 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=25 Participants
|
16 Participants
n=26 Participants
|
29 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=25 Participants
|
22 Participants
n=26 Participants
|
37 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=25 Participants
|
22 participants
n=26 Participants
|
38 participants
n=51 Participants
|
|
Body Mass Index (BMI)
|
31.93 kilograms per square meter
STANDARD_DEVIATION 7.47 • n=25 Participants
|
31.68 kilograms per square meter
STANDARD_DEVIATION 5.76 • n=26 Participants
|
31.79 kilograms per square meter
STANDARD_DEVIATION 6.43 • n=51 Participants
|
|
Smoking status = Former/Current Smoker
|
13 Participants
n=25 Participants
|
13 Participants
n=26 Participants
|
26 Participants
n=51 Participants
|
|
Diabetes
|
8 Participants
n=25 Participants
|
9 Participants
n=26 Participants
|
17 Participants
n=51 Participants
|
|
Hypertension
|
10 Participants
n=25 Participants
|
18 Participants
n=26 Participants
|
28 Participants
n=51 Participants
|
|
Hyperlipidemia
|
10 Participants
n=25 Participants
|
17 Participants
n=26 Participants
|
27 Participants
n=51 Participants
|
|
Coronary Artery Disease
|
11 Participants
n=25 Participants
|
14 Participants
n=26 Participants
|
25 Participants
n=51 Participants
|
|
Gastroesophageal Reflux Disease (GERD)
|
4 Participants
n=25 Participants
|
8 Participants
n=26 Participants
|
12 Participants
n=51 Participants
|
|
Obstructive Sleep Apnea (OSA)
|
2 Participants
n=25 Participants
|
1 Participants
n=26 Participants
|
3 Participants
n=51 Participants
|
|
Positive Imaging Study
|
7 Participants
n=25 Participants
|
12 Participants
n=26 Participants
|
19 Participants
n=51 Participants
|
|
Prior Myocardial Infarction (MI) at Admission
|
7 Participants
n=25 Participants
|
9 Participants
n=26 Participants
|
16 Participants
n=51 Participants
|
|
Renal Insufficiency
|
1 Participants
n=25 Participants
|
2 Participants
n=26 Participants
|
3 Participants
n=51 Participants
|
|
Non-Elective Procedure
|
7 Participants
n=25 Participants
|
8 Participants
n=26 Participants
|
15 Participants
n=51 Participants
|
|
Primary Procedure Angioplasty Stent Coronary
|
16 Participants
n=25 Participants
|
21 Participants
n=26 Participants
|
37 Participants
n=51 Participants
|
|
Length of Surgery
|
1.46 Hours
n=25 Participants
|
1.40 Hours
n=26 Participants
|
1.42 Hours
n=51 Participants
|
PRIMARY outcome
Timeframe: 6 hours after the loading dose of TicagrelorPopulation: Not all participants had a test completed at every time.
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
Outcome measures
| Measure |
Fentanyl and Crushed Ticagrelor
n=9 Participants
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
|
Fentanyl and Non-crushed Ticagrelor
n=12 Participants
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
|
|---|---|---|
|
Area Under the Platelet Function Testing (PFT)-Time Curve (AUC0-6) for the First 6 Hours After the Loading Dose of Ticagrelor
|
796.34 Platelet Reactive Units (PRUs)/hour
Interval 420.23 to 950.36
|
622.37 Platelet Reactive Units (PRUs)/hour
Interval 439.28 to 712.04
|
SECONDARY outcome
Timeframe: From time of procedure until hospital discharge, up to 3 daysStent thrombosis while in hospital from time of procedure until discharge
Outcome measures
| Measure |
Fentanyl and Crushed Ticagrelor
n=16 Participants
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
|
Fentanyl and Non-crushed Ticagrelor
n=22 Participants
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
|
|---|---|---|
|
In-Hospital Stent Thrombosis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From time of procedure until hospital discharge, up to 3 daysTIMI 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.
Outcome measures
| Measure |
Fentanyl and Crushed Ticagrelor
n=16 Participants
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
|
Fentanyl and Non-crushed Ticagrelor
n=22 Participants
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
|
|---|---|---|
|
In-Hospital Thrombolysis in Myocardial Infarction (TIMI) Major and Minor Bleeding
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From time of procedure until hospital discharge, up to 3 daysMyocardial Infarction while in hospital from time of procedure until discharge
Outcome measures
| Measure |
Fentanyl and Crushed Ticagrelor
n=16 Participants
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
|
Fentanyl and Non-crushed Ticagrelor
n=22 Participants
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
|
|---|---|---|
|
In-Hospital Recurrent Myocardial Infarction
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From time of procedure until hospital discharge, up to 3 daysStroke while in hospital from time of procedure until discharge
Outcome measures
| Measure |
Fentanyl and Crushed Ticagrelor
n=16 Participants
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
|
Fentanyl and Non-crushed Ticagrelor
n=22 Participants
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
|
|---|---|---|
|
In-Hospital Stroke
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From time of procedure until hospital discharge, up to 3 daysDeath while in hospital from time of procedure until discharge
Outcome measures
| Measure |
Fentanyl and Crushed Ticagrelor
n=16 Participants
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
|
Fentanyl and Non-crushed Ticagrelor
n=22 Participants
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
|
|---|---|---|
|
In-Hospital Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days after hospital dischargeStent Thrombosis within 30 days from hospital discharge
Outcome measures
| Measure |
Fentanyl and Crushed Ticagrelor
n=16 Participants
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
|
Fentanyl and Non-crushed Ticagrelor
n=22 Participants
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
|
|---|---|---|
|
30-Day Stent Thrombosis
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days after hospital dischargeTIMI 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.
Outcome measures
| Measure |
Fentanyl and Crushed Ticagrelor
n=16 Participants
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
|
Fentanyl and Non-crushed Ticagrelor
n=22 Participants
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
|
|---|---|---|
|
30-Day TIMI Major and Minor Bleeding
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days after hospital dischargeRecurrent myocardial infarction within 30 days after hospital discharge.
Outcome measures
| Measure |
Fentanyl and Crushed Ticagrelor
n=16 Participants
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
|
Fentanyl and Non-crushed Ticagrelor
n=22 Participants
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
|
|---|---|---|
|
30-Day Recurrent Myocardial Infarction
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 days after hospital dishargeStroke within 30 days after hospital discharge
Outcome measures
| Measure |
Fentanyl and Crushed Ticagrelor
n=16 Participants
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
|
Fentanyl and Non-crushed Ticagrelor
n=22 Participants
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
|
|---|---|---|
|
30-Day Stroke
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days after hospital dischargeDeath within 30 days after hospital discharge
Outcome measures
| Measure |
Fentanyl and Crushed Ticagrelor
n=16 Participants
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
|
Fentanyl and Non-crushed Ticagrelor
n=22 Participants
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
|
|---|---|---|
|
30-Day All-cause Mortality (Death)
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From admission for the procedure until discharge, assessed up to 3 daysTime (Hours) in the hospital from admission for the procedure until discharge
Outcome measures
| Measure |
Fentanyl and Crushed Ticagrelor
n=16 Participants
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
|
Fentanyl and Non-crushed Ticagrelor
n=22 Participants
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
|
|---|---|---|
|
Hospital Length of Stay
|
27.00 Hours
Interval 23.0 to 40.0
|
28.50 Hours
Interval 22.25 to 48.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days after hospital dischargeReadmission to the hospital within 30 days of discharge
Outcome measures
| Measure |
Fentanyl and Crushed Ticagrelor
n=16 Participants
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
|
Fentanyl and Non-crushed Ticagrelor
n=22 Participants
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
|
|---|---|---|
|
30-Day Hospital Readmission
|
0 Participants
|
1 Participants
|
Adverse Events
Fentanyl and Crushed Ticagrelor
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Fentanyl and Non-crushed Ticagrelor
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fentanyl and Crushed Ticagrelor
n=16 participants at risk
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
|
Fentanyl and Non-crushed Ticagrelor
n=22 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Stent Thrombosis
|
6.2%
1/16 • Number of events 1 • 30 days after hospital discharge
|
0.00%
0/22 • 30 days after hospital discharge
|
|
Blood and lymphatic system disorders
TIMI bleeding
|
0.00%
0/16 • 30 days after hospital discharge
|
0.00%
0/22 • 30 days after hospital discharge
|
|
Cardiac disorders
Myocardial Infarction
|
6.2%
1/16 • Number of events 1 • 30 days after hospital discharge
|
9.1%
2/22 • Number of events 2 • 30 days after hospital discharge
|
|
Nervous system disorders
Stroke
|
0.00%
0/16 • 30 days after hospital discharge
|
0.00%
0/22 • 30 days after hospital discharge
|
Other adverse events
Adverse event data not reported
Additional Information
Sudhakar Sattur MD, Principal Investigator
The Guthrie Clinic
Phone: 570-887-4882
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place