Trial Outcomes & Findings for Prasugrel Versus Ticagrelor in Patients With CYP2C19 Loss-of-function: a Validation Study (NCT NCT03489863)
NCT ID: NCT03489863
Last Updated: 2020-09-16
Results Overview
Platelet reactivity measured by VerifyNow and reported as PRU
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
14 participants
Primary outcome timeframe
at 24 hours post loading dose
Results posted on
2020-09-16
Participant Flow
Participant milestones
| Measure |
Prasugrel
Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).
Prasugrel: Maintenance dose will be maintained for 10±3 days.
|
Ticagrelor
Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).
Ticagrelor: Maintenance dose will be maintained for 10±3 days.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Prasugrel
Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).
Prasugrel: Maintenance dose will be maintained for 10±3 days.
|
Ticagrelor
Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).
Ticagrelor: Maintenance dose will be maintained for 10±3 days.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Prasugrel Versus Ticagrelor in Patients With CYP2C19 Loss-of-function: a Validation Study
Baseline characteristics by cohort
| Measure |
Prasugrel
n=7 Participants
Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).
Prasugrel: Maintenance dose will be maintained for 10±3 days.
|
Ticagrelor
n=7 Participants
Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).
Ticagrelor: Maintenance dose will be maintained for 10±3 days.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 8 • n=5 Participants
|
60 years
STANDARD_DEVIATION 8 • n=7 Participants
|
59 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
diabetes mellitus
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 24 hours post loading dosePlatelet reactivity measured by VerifyNow and reported as PRU
Outcome measures
| Measure |
Prasugrel
n=7 Participants
Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).
Prasugrel: Maintenance dose will be maintained for 10±3 days.
|
Ticagrelor
n=6 Participants
Patients will be randomly (1:1) assigned to receive FDA approved doses of either prasugrel (60 mg loading dose - 10 mg/day maintenance dose) or ticagrelor (180 mg loading dose - 90 mg b.i.d maintenance dose).
Ticagrelor: Maintenance dose will be maintained for 10±3 days.
|
|---|---|---|
|
P2Y12 Reaction Unit (PRU)
|
5 PRU
Standard Deviation 10
|
24 PRU
Standard Deviation 22
|
Adverse Events
Prasugrel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ticagrelor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dominick J. Angiolillo
University of Florida College of Medicine Jacksonville
Phone: 9042443378
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place