Trial Outcomes & Findings for Effect of Prasugrel Versus Clopidogrel on Platelet Function After Bivalirudin Cessation (NCT NCT01789814)
NCT ID: NCT01789814
Last Updated: 2017-04-04
Results Overview
To document the extent of inhibition of ADP mediated platelet aggregation following the discontinuation of bivalirudin therapy in patients treated with prasugrel as compared to patients treated with clopidogrel. The percent inhibition of platelet aggregation was measured by light transmission aggregometry of platelet-rich plasma in response to P2Y12 and PAR1 and PAR4 thrombin receptor agonists at baseline and at 1, 2, 4 and 16 h following the cessation of bivalirudin infusion. Platelet response to agonists: 20 mM ADP(P2Y12), 5 mM SFLLRN (PAR1), and 160 mM AYPGKF (PAR4) was performed. The magnitude of inhibition of platelet aggregation for each agonist was calculated as the mean final change from baseline in light transmission aggregometry at each time point.
COMPLETED
PHASE4
24 participants
Baseline, 60, 120, 240, 960 mins following termination of bivalirudin infusion
2017-04-04
Participant Flow
24 subjects were enrolled to complete this study. The enrollment process took place in the adult cardiac catheterization laboratory at this hosptial. The inform consent process took place at the subject arrival time for the date procedure.
The randomized arm assignment was done by numbered envelopes. Once it was confirmed the subject was going to have a coronary intervention, the correspondent envelope was opened to assign the study arm drug.
Participant milestones
| Measure |
Prasugrel
Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention
Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy.
|
Clopidogrel
Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention
Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Prasugrel Versus Clopidogrel on Platelet Function After Bivalirudin Cessation
Baseline characteristics by cohort
| Measure |
Prasugrel
n=12 Participants
Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention
Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy.
|
Clopidogrel
n=12 Participants
Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention
Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Age, Continuous
|
60.41 years
STANDARD_DEVIATION 9.80 • n=93 Participants
|
62.5 years
STANDARD_DEVIATION 80.5 • n=4 Participants
|
61.99 years
STANDARD_DEVIATION 8.82 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 60, 120, 240, 960 mins following termination of bivalirudin infusionPopulation: 24 patients referred for intervention with planned bivalirudin therapy, not previously treated with a P2Y12 inhibitor and not receiving heparins or GP IIb/IIIa inhibitors were randomized to treatment with either clopidogrel (600 mg) or prasugrel (60 mg).
To document the extent of inhibition of ADP mediated platelet aggregation following the discontinuation of bivalirudin therapy in patients treated with prasugrel as compared to patients treated with clopidogrel. The percent inhibition of platelet aggregation was measured by light transmission aggregometry of platelet-rich plasma in response to P2Y12 and PAR1 and PAR4 thrombin receptor agonists at baseline and at 1, 2, 4 and 16 h following the cessation of bivalirudin infusion. Platelet response to agonists: 20 mM ADP(P2Y12), 5 mM SFLLRN (PAR1), and 160 mM AYPGKF (PAR4) was performed. The magnitude of inhibition of platelet aggregation for each agonist was calculated as the mean final change from baseline in light transmission aggregometry at each time point.
Outcome measures
| Measure |
Prasugrel
n=12 Participants
Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention
Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy.
|
Clopidogrel
n=12 Participants
Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention
Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter
.
|
|---|---|---|
|
Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF.
ADP 20 uM-1 hour %
|
84 % inhibitn of platelet aggregation
|
38 % inhibitn of platelet aggregation
|
|
Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF.
SFFLRN 5 uM-4 hour
|
75 % inhibitn of platelet aggregation
|
17 % inhibitn of platelet aggregation
|
|
Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF.
AYP 160 uM-4 hour
|
53 % inhibitn of platelet aggregation
|
13 % inhibitn of platelet aggregation
|
|
Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF.
ADP 20 uM-2 hour %
|
94 % inhibitn of platelet aggregation
|
53 % inhibitn of platelet aggregation
|
|
Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF.
ADP 20 uM-4 hour %
|
98 % inhibitn of platelet aggregation
|
85 % inhibitn of platelet aggregation
|
|
Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF.
ADP 20 uM-16 hour %
|
98 % inhibitn of platelet aggregation
|
85 % inhibitn of platelet aggregation
|
|
Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF.
SFFLRN 5 uM-1 hour
|
62 % inhibitn of platelet aggregation
|
2 % inhibitn of platelet aggregation
|
|
Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF.
SFFLRN 5 uM-2 hour
|
64 % inhibitn of platelet aggregation
|
9 % inhibitn of platelet aggregation
|
|
Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF.
SFFLRN 5 uM-16 hour
|
58 % inhibitn of platelet aggregation
|
15 % inhibitn of platelet aggregation
|
|
Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF.
AYP 160 uM-1 hour
|
39 % inhibitn of platelet aggregation
|
7 % inhibitn of platelet aggregation
|
|
Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF.
AYP 160 uM-2 hour
|
44 % inhibitn of platelet aggregation
|
9 % inhibitn of platelet aggregation
|
|
Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF.
AYP 160 uM-16 hour
|
41 % inhibitn of platelet aggregation
|
11 % inhibitn of platelet aggregation
|
Adverse Events
Prasugrel
Clopidogrel
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carey Kimmelstiel, MD Director of the Adult Cardiac Catheterization Laboratory
Tufts Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place