Trial Outcomes & Findings for The Platelet Aggregation After tiCagrelor Inhibition and FentanYl Trial (PACIFY) (NCT NCT02683707)
NCT ID: NCT02683707
Last Updated: 2018-06-07
Results Overview
Area under the curve for Ticagrelor Absorption
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
212 participants
Primary outcome timeframe
Measured over 24 hours (at 0, 0.5, 1, 2, 4, and 24 hours)
Results posted on
2018-06-07
Participant Flow
Participant milestones
| Measure |
PCI Without Intranvenous (IV) Opiate
IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)
Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for percutaneous coronary intervention \[PCI\])
Lidocaine: Local Anesthetic
Midazolam: IV sedation
|
PCI With IV Opiate
IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia
Fentanyl: IV peri-procedural analgesia
Lidocaine: Local Anesthetic
Midazolam: IV sedation
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
107
|
|
Overall Study
COMPLETED
|
105
|
107
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Platelet Aggregation After tiCagrelor Inhibition and FentanYl Trial (PACIFY)
Baseline characteristics by cohort
| Measure |
PCI Without IV Opiate
n=105 Participants
IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)
Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI)
Lidocaine: Local Anesthetic
Midazolam: IV sedation
|
PCI With IV Opiate
n=107 Participants
IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia
Fentanyl: IV peri-procedural analgesia
Lidocaine: Local Anesthetic
Midazolam: IV sedation
|
Total
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 9.3 • n=39 Participants
|
63 years
STANDARD_DEVIATION 10.2 • n=41 Participants
|
64 years
STANDARD_DEVIATION 10 • n=35 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
67 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=39 Participants
|
82 Participants
n=41 Participants
|
145 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
36 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
79 Participants
n=39 Participants
|
75 Participants
n=41 Participants
|
154 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
105 Participants
n=39 Participants
|
107 Participants
n=41 Participants
|
212 Participants
n=35 Participants
|
|
Platelet count
|
230 K/cu mm
STANDARD_DEVIATION 59 • n=39 Participants
|
223 K/cu mm
STANDARD_DEVIATION 71 • n=41 Participants
|
226 K/cu mm
STANDARD_DEVIATION 65 • n=35 Participants
|
PRIMARY outcome
Timeframe: Measured over 24 hours (at 0, 0.5, 1, 2, 4, and 24 hours)Population: Only the subgroup (n=70) of enrolled participants who required PCI and were loaded with ticagrelor had information on the primary endpoint
Area under the curve for Ticagrelor Absorption
Outcome measures
| Measure |
PCI Without IV Opiate
n=35 Participants
IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)
Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI)
Lidocaine: Local Anesthetic
Midazolam: IV sedation
|
PCI With IV Opiate
n=35 Participants
IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia
Fentanyl: IV peri-procedural analgesia
Lidocaine: Local Anesthetic
Midazolam: IV sedation
|
|---|---|---|
|
Ticagrelor Pharmacokinetics
|
3301 ng*hr/mL
Standard Error 271
|
2107 ng*hr/mL
Standard Error 301
|
SECONDARY outcome
Timeframe: Measured at 2 hoursPopulation: Only the subgroup (n=70) of enrolled participants who required PCI and were loaded with ticagrelor had information on the primary endpoint
Blood test of Platelet Cell Reactivity using Verify Now (P2Y12 Reactivity Units)
Outcome measures
| Measure |
PCI Without IV Opiate
n=35 Participants
IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)
Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI)
Lidocaine: Local Anesthetic
Midazolam: IV sedation
|
PCI With IV Opiate
n=35 Participants
IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia
Fentanyl: IV peri-procedural analgesia
Lidocaine: Local Anesthetic
Midazolam: IV sedation
|
|---|---|---|
|
Single Time-point Platelet Reactivity Using Verify Now
|
78 PRUs
Standard Deviation 72
|
112 PRUs
Standard Deviation 95
|
SECONDARY outcome
Timeframe: Measured at 2 hoursPopulation: Only the subgroup (n=70) of enrolled participants who required PCI and were loaded with ticagrelor had information on the primary endpoint
Blood test of Platelet Cell Reactivity using Light Transmission Aggregometry (reported as percent of baseline aggregation in response to adenosine diphosphate stimulation)
Outcome measures
| Measure |
PCI Without IV Opiate
n=35 Participants
IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)
Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI)
Lidocaine: Local Anesthetic
Midazolam: IV sedation
|
PCI With IV Opiate
n=35 Participants
IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia
Fentanyl: IV peri-procedural analgesia
Lidocaine: Local Anesthetic
Midazolam: IV sedation
|
|---|---|---|
|
Platelet Reactivity Using Light Transmission Aggregometry
|
27.5 percentage of baseline aggregation
Standard Deviation 14.4
|
39.3 percentage of baseline aggregation
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: 2 hoursPatient self report of pain using a visual analog scale (VAS). Scale ranges from 0 to 10 with 0 being "No pain" and 10 being "Most severe pain".
Outcome measures
| Measure |
PCI Without IV Opiate
n=105 Participants
IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)
Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI)
Lidocaine: Local Anesthetic
Midazolam: IV sedation
|
PCI With IV Opiate
n=107 Participants
IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia
Fentanyl: IV peri-procedural analgesia
Lidocaine: Local Anesthetic
Midazolam: IV sedation
|
|---|---|---|
|
Patient Self-reported Pain
|
2.3 units on a scale
Standard Deviation 3.1
|
1.5 units on a scale
Standard Deviation 2.3
|
Adverse Events
PCI Without IV Opiate
Serious events: 13 serious events
Other events: 0 other events
Deaths: 0 deaths
PCI With IV Opiate
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PCI Without IV Opiate
n=105 participants at risk
IV midazolam and Local Anesthetic, with removal of IV fentanyl from peri-procedural analgesia (which is otherwise routinely given)
Removal of Fentanyl from peri-procedural analgesia: Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI)
Lidocaine: Local Anesthetic
Midazolam: IV sedation
|
PCI With IV Opiate
n=107 participants at risk
IV midazolam and Local Anesthetic and IV fentanyl for peri-procedural analgesia
Fentanyl: IV peri-procedural analgesia
Lidocaine: Local Anesthetic
Midazolam: IV sedation
|
|---|---|---|
|
General disorders
Pain >5/10
|
12.4%
13/105 • Number of events 13 • Adverse event data (specifically pain and anxiety reports from participants) were collected on the day of the procedure during which each participant was under study.
|
6.5%
7/107 • Number of events 7 • Adverse event data (specifically pain and anxiety reports from participants) were collected on the day of the procedure during which each participant was under study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place