Trial Outcomes & Findings for Pharmacological Effects of Crushing Prasugrel in STEMI Patients (NCT NCT02212028)
NCT ID: NCT02212028
Last Updated: 2016-12-28
Results Overview
The primary end-point of the study is the comparison in platelet reactivity expressed as PRU determined by VerifyNow P2Y12 between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration
COMPLETED
PHASE4
52 participants
2 hrs
2016-12-28
Participant Flow
Between October 15, 2014, and August 12, 2015, there were a total of 123 patients presenting with a STEMI at the University of Florida Health-Jacksonville, that were screened.
45 patients did not meet study entry criteria, while 78 provided their written informed consent to participate in the study and, of these, 52 were randomized. the remaining subjects were not randomized because of exclusion criteria emerged after consenting.
Participant milestones
| Measure |
Prasugrel Crush
Prasugrel 60mg loading dose as crushed tablets
|
Prasugrel Tablets
Prasugrel 60 mg loading dose whole tablets
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacological Effects of Crushing Prasugrel in STEMI Patients
Baseline characteristics by cohort
| Measure |
Prasugrel Crush
n=26 Participants
Prasugrel 60mg loading dose as crushed tablets
|
Prasugrel Tablets
n=24 Participants
Prasugrel 60 mg loading dose whole tablets
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 9 • n=99 Participants
|
58 years
STANDARD_DEVIATION 10 • n=107 Participants
|
58 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Gender
Female
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Gender
Male
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 hrsPopulation: The primary population was defined as patients who received the randomized treatment and had a valid primary end point value (PRU at 2 hours) and was considered for analysis of all endpoints.
The primary end-point of the study is the comparison in platelet reactivity expressed as PRU determined by VerifyNow P2Y12 between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration
Outcome measures
| Measure |
Prasugrel Crush
n=26 Participants
Prasugrel 60mg loading dose as crushed tablets
|
Prasugrel Tablets
n=24 Participants
Prasugrel 60 mg loading dose whole tablets
|
|---|---|---|
|
P2Y12 Reaction Units (PRU)
|
95 PRU
Interval 55.0 to 135.0
|
164 PRU
Interval 122.0 to 206.0
|
SECONDARY outcome
Timeframe: 2 hrsPopulation: The primary population was defined as patients who received the randomized treatment and had a valid primary end point value (PRU at 2 hours) and was considered for analysis of all endpoints.
The secondary end-point of the study is the comparison in platelet reactivity expressed as PRI determined by whole blood vasodilator-stimulated phosphoprotein (VASP) between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration
Outcome measures
| Measure |
Prasugrel Crush
n=26 Participants
Prasugrel 60mg loading dose as crushed tablets
|
Prasugrel Tablets
n=24 Participants
Prasugrel 60 mg loading dose whole tablets
|
|---|---|---|
|
Platelet Reactivity Index (PRI)
|
33 PRI
Interval 20.0 to 46.0
|
61 PRI
Interval 47.0 to 75.0
|
Adverse Events
Prasugrel Crush
Prasugrel Tablets
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prasugrel Crush
n=26 participants at risk
Prasugrel 60mg loading dose as crushed tablets
|
Prasugrel Tablets
n=26 participants at risk
Prasugrel 60 mg loading dose whole tablets
|
|---|---|---|
|
Renal and urinary disorders
Minor bleeding
|
3.8%
1/26 • Number of events 1 • 3 days
In-hospital adverse events, including ischemic and bleeding complications were recorded.
|
0.00%
0/26 • 3 days
In-hospital adverse events, including ischemic and bleeding complications were recorded.
|
Additional Information
Dominick J. Angiolillo, MD, PhD
University of Florida College of Medicine-Jacksonville
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place