Trial Outcomes & Findings for A Pharmacodynamic Study Comparing Prasugrel Versus Ticagrelor in Patients Undergoing PCI With CYP2C19 Loss-of-function: (NCT NCT02065479)
NCT ID: NCT02065479
Last Updated: 2020-09-16
Results Overview
The primary endpoint is P2Y12 reaction unit (PRU) measured by the Verify Now P2Y12 assay 24hours/hospital discharge post randomization to prasugrel vs ticagrelor. PRU is is an arbitrary unit of measure to assess ADP-induced platelet aggregation.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
65 participants
Primary outcome timeframe
24 hours post loading dose
Results posted on
2020-09-16
Participant Flow
Participant milestones
| Measure |
Ticagrelor
The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.
Prasugrel: Comparison of platelet reactivity between prasugrel and ticagrelor
|
Prasugrel
The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.
Ticagrelor: Comparison of platelet reactivity between prasugrel and ticagrelor
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
32
|
|
Overall Study
COMPLETED
|
33
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pharmacodynamic Study Comparing Prasugrel Versus Ticagrelor in Patients Undergoing PCI With CYP2C19 Loss-of-function:
Baseline characteristics by cohort
| Measure |
Ticagrelor
n=33 Participants
The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.
Prasugrel: Comparison of platelet reactivity between prasugrel and ticagrelor
|
Prasugrel
n=32 Participants
The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.
Ticagrelor: Comparison of platelet reactivity between prasugrel and ticagrelor
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 8 • n=39 Participants
|
60 years
STANDARD_DEVIATION 9 • n=41 Participants
|
59 years
STANDARD_DEVIATION 9 • n=35 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
51 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
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 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
|
8 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
44 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
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=39 Participants
|
32 Participants
n=41 Participants
|
65 Participants
n=35 Participants
|
|
Diabetes Mellitus
|
10 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 24 hours post loading doseThe primary endpoint is P2Y12 reaction unit (PRU) measured by the Verify Now P2Y12 assay 24hours/hospital discharge post randomization to prasugrel vs ticagrelor. PRU is is an arbitrary unit of measure to assess ADP-induced platelet aggregation.
Outcome measures
| Measure |
Ticagrelor
n=33 Participants
The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.
Prasugrel: Comparison of platelet reactivity between prasugrel and ticagrelor
|
Prasugrel
n=32 Participants
The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.
Ticagrelor: Comparison of platelet reactivity between prasugrel and ticagrelor
|
|---|---|---|
|
Platelet Reactivity
|
36 PRU
Standard Deviation 41
|
33 PRU
Standard Deviation 56
|
Adverse Events
Ticagrelor
Serious events: 0 serious events
Other events: 3 other events
Deaths: 33 deaths
Prasugrel
Serious events: 1 serious events
Other events: 0 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Ticagrelor
n=33 participants at risk
The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.
Prasugrel: Comparison of platelet reactivity between prasugrel and ticagrelor
|
Prasugrel
n=32 participants at risk
The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.
Ticagrelor: Comparison of platelet reactivity between prasugrel and ticagrelor
|
|---|---|---|
|
Vascular disorders
Stroke
|
0.00%
0/33 • 4 weeks
|
3.1%
1/32 • Number of events 1 • 4 weeks
|
Other adverse events
| Measure |
Ticagrelor
n=33 participants at risk
The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.
Prasugrel: Comparison of platelet reactivity between prasugrel and ticagrelor
|
Prasugrel
n=32 participants at risk
The primary endpoint is the non-inferiority in platelet reactivity of prasugrel versus ticagrelor among CYP2C19 loss of function allele carriers.
Ticagrelor: Comparison of platelet reactivity between prasugrel and ticagrelor
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dypnea
|
9.1%
3/33 • Number of events 3 • 4 weeks
|
0.00%
0/32 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place