Trial Outcomes & Findings for Study to Learn When Platelets Return to Normal After One Loading Dose of Anti-platelet Drugs in Patients With Symptoms of Acute Coronary Syndromes (NCT NCT01107899)
NCT ID: NCT01107899
Last Updated: 2012-03-09
Results Overview
Participants were classified as having platelet function return to baseline after loading dose (LD) on the first day that P2Y12 Reaction Units (PRU) was no more than 60 PRU below baseline and remained in this range. PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of adenosine diphosphate (ADP)-stimulated platelet aggregation.
TERMINATED
PHASE1
29 participants
Days 3, 5, 7, 9, and 11
2012-03-09
Participant Flow
Participant milestones
| Measure |
Clopidogrel 600 mg
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 60 mg
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 30 mg
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
9
|
|
Overall Study
Received at Least One Dose of Study Drug
|
10
|
10
|
8
|
|
Overall Study
Loading Dose (LD) Intent to Treat (ITT)
|
5
|
10
|
6
|
|
Overall Study
ITT Washout Population
|
5
|
10
|
6
|
|
Overall Study
Primary Washout Population
|
5
|
10
|
4
|
|
Overall Study
COMPLETED
|
5
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
4
|
Reasons for withdrawal
| Measure |
Clopidogrel 600 mg
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 60 mg
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 30 mg
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
5
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Study to Learn When Platelets Return to Normal After One Loading Dose of Anti-platelet Drugs in Patients With Symptoms of Acute Coronary Syndromes
Baseline characteristics by cohort
| Measure |
Clopidogrel 600 mg
n=10 Participants
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 60 mg
n=10 Participants
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 30 mg
n=9 Participants
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
66.9 years
STANDARD_DEVIATION 8.54 • n=5 Participants
|
65.6 years
STANDARD_DEVIATION 6.56 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 10.01 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 8.44 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
29 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Days 3, 5, 7, 9, and 11Population: Primary Washout Population: Included participants who completed the study, had evaluable pharmacodynamic (PD) data through Day 11. Participants with a missed visit were not included in the Primary Washout Population.
Participants were classified as having platelet function return to baseline after loading dose (LD) on the first day that P2Y12 Reaction Units (PRU) was no more than 60 PRU below baseline and remained in this range. PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of adenosine diphosphate (ADP)-stimulated platelet aggregation.
Outcome measures
| Measure |
Clopidogrel 600 mg
n=5 Participants
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 60 mg
n=10 Participants
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 30 mg
n=4 Participants
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
|---|---|---|---|
|
Percentage of Participants Returning to Baseline Platelet Function
Day 3
|
60.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Returning to Baseline Platelet Function
Day 5
|
80.0 percentage of participants
|
10.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Returning to Baseline Platelet Function
Day 7
|
100.0 percentage of participants
|
60.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Returning to Baseline Platelet Function
Day 9
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Returning to Baseline Platelet Function
Day 11
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up through 11 daysPopulation: Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.
This outcome measure was not analyzed due to the limited sample size.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up through 11 daysPopulation: Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.
The day at which the proportion of participants who return to baseline platelet P2Y12 receptor function in the prasugrel 30 mg and 60 mg LD groups is similar (within 10% absolute difference) to the proportion of subjects who return to baseline platelet P2Y12 receptor function at day 5 and day 7 in the clopidogrel 600 mg LD group, obtained from Kaplan Meier curves for the primary washout population, was to be presented. This outcome measure was not analyzed due to the limited sample size.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up through 11 daysPopulation: Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.
The return of baseline platelet function following one LD of prasugrel (30 mg or 60 mg) or 600 mg LD of clopidogrel assessed by Verify Now™ P2Y12 Reaction Units (VN-PRU). This outcome measure was not analyzed because it was not appropriate to estimate the days based on the non-inferiority approach due to the limited sample size.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up through 11 daysPopulation: ITT Washout Population: All randomized participants who received study drug LD, had an evaluable baseline PD measurement (pre-LD), and had at least 1 evaluable PD measurement post-LD. One participant discontinued on Day 3 without returning to baseline and is not included in analysis.
To show effect of initial inhibition of platelet aggregation as measured by Accumetrics Verify Now™ P2Y12 on the day to return to baseline platelet function, a regression model was fitted with day to return as outcome variable and initial inhibition as fixed effect. Results are reported as the predicted day to return to baseline platelet function by derived VN-PRU percent (%) inhibition at 24 hours post LD. The derived VN-PRU % inhibition is calculated as a percent decrease of PRU from baseline using the following formula: (\[PRU at baseline - PRU at 24 hours post LD\]/PRU at baseline) x 100%.
Outcome measures
| Measure |
Clopidogrel 600 mg
n=20 Participants
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 60 mg
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 30 mg
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
|---|---|---|---|
|
Effect of Initial Inhibition of Platelet Aggregation on the Day to Return to Baseline Platelet Function: VN-PRU
20% Initial Inhibition
|
3.2 days
|
—
|
—
|
|
Effect of Initial Inhibition of Platelet Aggregation on the Day to Return to Baseline Platelet Function: VN-PRU
40% Initial Inhibition
|
4.6 days
|
—
|
—
|
|
Effect of Initial Inhibition of Platelet Aggregation on the Day to Return to Baseline Platelet Function: VN-PRU
60% Initial Inhibition
|
6.0 days
|
—
|
—
|
|
Effect of Initial Inhibition of Platelet Aggregation on the Day to Return to Baseline Platelet Function: VN-PRU
80% Initial Inhibition
|
7.4 days
|
—
|
—
|
SECONDARY outcome
Timeframe: Up through 11 daysPopulation: Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.
PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of adenosine diphosphate (ADP)-stimulated platelet aggregation. This outcome measure was not analyzed due to the limited sample size.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hours post-loading dosePopulation: LD ITT population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD.
PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of ADP-stimulated platelet aggregation.
Outcome measures
| Measure |
Clopidogrel 600 mg
n=5 Participants
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 60 mg
n=10 Participants
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 30 mg
n=6 Participants
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
|---|---|---|---|
|
Platelet Function 24 Hours Post Loading Dose
|
193.0 P2Y12 Reaction Units (PRU)
Standard Deviation 83.58
|
32.5 P2Y12 Reaction Units (PRU)
Standard Deviation 20.79
|
70.0 P2Y12 Reaction Units (PRU)
Standard Deviation 56.23
|
SECONDARY outcome
Timeframe: 24 hours post-loading dosePopulation: LD ITT Population: All randomized participants who received an LD with evaluable PD measurements.
Platelet aggregation was assessed by Accumetrics Verify Now™ P2Y12, and poor responders were those with PRU greater than or equal to 230.
Outcome measures
| Measure |
Clopidogrel 600 mg
n=5 Participants
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 60 mg
n=10 Participants
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 30 mg
n=6 Participants
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
|---|---|---|---|
|
Percentage of Poor Pharmacodynamic Responders by Platelet Aggregation at 24 Hours Post-LD
|
40.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up through 11 daysPopulation: ITT Washout Population: All randomized participants who received the study drug LD, had an evaluable baseline PD measurement (pre-LD), and had at least 1 evaluable PD measurement post-LD.
Initial inhibition of platelet aggregation was measured by LTA at 5 and 20 μM ADP. Maximum platelet aggregation (MPA) is reported by day.
Outcome measures
| Measure |
Clopidogrel 600 mg
n=5 Participants
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 60 mg
n=10 Participants
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 30 mg
n=6 Participants
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
|---|---|---|---|
|
Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)
Baseline (20 μM ADP) (n=5, n=10, n=6)
|
68.00 percent platelet aggregation
Interval 61.82 to 74.18
|
72.70 percent platelet aggregation
Interval 65.31 to 80.09
|
76.33 percent platelet aggregation
Interval 66.76 to 85.91
|
|
Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)
Day 1 (20 μM ADP) (n=5, n=10, n=6)
|
52.60 percent platelet aggregation
Interval 32.96 to 72.24
|
27.30 percent platelet aggregation
Interval 21.0 to 33.6
|
31.67 percent platelet aggregation
Interval 22.51 to 40.82
|
|
Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)
Day 3 (20 μM ADP) (n=5, n=10, n=6)
|
56.00 percent platelet aggregation
Interval 40.25 to 71.75
|
42.50 percent platelet aggregation
Interval 37.69 to 47.31
|
46.33 percent platelet aggregation
Interval 33.38 to 59.28
|
|
Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)
Day 5 (20 μM ADP) (n=5, n=10, n=4)
|
70.40 percent platelet aggregation
Interval 59.41 to 81.39
|
47.00 percent platelet aggregation
Interval 42.5 to 51.5
|
58.25 percent platelet aggregation
Interval 41.24 to 75.26
|
|
Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)
Day 7 (20 μM ADP) (n=5, n=10, n=5)
|
71.00 percent platelet aggregation
Interval 53.46 to 88.54
|
58.30 percent platelet aggregation
Interval 53.14 to 63.46
|
73.20 percent platelet aggregation
Interval 55.55 to 90.85
|
|
Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)
Day 9 (20 μM ADP) (n=5, n=10, n=5)
|
62.40 percent platelet aggregation
Interval 41.97 to 82.83
|
62.00 percent platelet aggregation
Interval 52.2 to 71.8
|
68.60 percent platelet aggregation
Interval 59.44 to 77.76
|
|
Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)
Day 11 (20 μM ADP) (n=5, n=10, n=5)
|
72.00 percent platelet aggregation
Interval 59.59 to 84.41
|
65.20 percent platelet aggregation
Interval 58.11 to 72.29
|
63.80 percent platelet aggregation
Interval 33.21 to 94.39
|
|
Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)
Baseline (5 μM ADP) (n=5, n=10, n=6)
|
64.40 percent platelet aggregation
Interval 60.21 to 68.59
|
62.60 percent platelet aggregation
Interval 55.76 to 69.44
|
70.67 percent platelet aggregation
Interval 65.42 to 75.91
|
|
Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)
Day 1 (5 μM ADP) (n=5, n=10, n=6)
|
39.40 percent platelet aggregation
Interval 23.4 to 55.4
|
22.00 percent platelet aggregation
Interval 15.37 to 28.63
|
25.50 percent platelet aggregation
Interval 18.18 to 32.82
|
|
Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)
Day 3 (5 μM ADP) (n=5, n=10, n=6)
|
50.20 percent platelet aggregation
Interval 36.31 to 64.09
|
32.80 percent platelet aggregation
Interval 28.73 to 36.87
|
48.67 percent platelet aggregation
Interval 38.85 to 58.48
|
|
Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)
Day 5 (5 μM ADP) (n=5, n=10, n=4)
|
64.20 percent platelet aggregation
Interval 48.17 to 80.23
|
39.50 percent platelet aggregation
Interval 34.26 to 44.74
|
53.25 percent platelet aggregation
Interval 38.23 to 68.27
|
|
Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)
Day 7 (5 μM ADP) (n=5, n=10, n=5)
|
60.40 percent platelet aggregation
Interval 40.9 to 79.9
|
52.40 percent platelet aggregation
Interval 44.95 to 59.85
|
65.40 percent platelet aggregation
Interval 46.91 to 83.89
|
|
Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)
Day 9 (5 μM ADP) (n=5, n=10, n=5)
|
58.40 percent platelet aggregation
Interval 35.53 to 81.27
|
56.00 percent platelet aggregation
Interval 46.46 to 65.54
|
60.00 percent platelet aggregation
Interval 51.55 to 68.45
|
|
Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)
Day 11 (5 μM ADP) (n=5, n=10, n=5)
|
61.80 percent platelet aggregation
Interval 50.53 to 73.07
|
58.90 percent platelet aggregation
Interval 51.85 to 65.95
|
56.00 percent platelet aggregation
Interval 29.54 to 82.46
|
SECONDARY outcome
Timeframe: Up through 11 daysPopulation: ITT Washout Population: All randomized participants who received the study drug LD, had an evaluable baseline PD measurement (pre-LD), and had at least 1 evaluable PD measurement post-LD.
Return of baseline platelet function was assessed by Multiplate® ADP test and ADP test High Sensitivity (HS). Multiplate analyzer was used to assess platelet aggregation based on impedance aggregometry in whole blood. The agonist ADP was added to stirred whole blood after dilution (1:2 with 0.9% NaCl solution) in a final concentration of 6.4 µM (ADP Test) or in final concentration of 6.4 µM ADP plus 9.4 nM Prostaglandin E1 (PGE1) (ADPtest HS). Platelet aggregation was continuously recorded for 5 minutes and quantified as area under the aggregation curve (AUC=AU\*min) of aggregation units (AU).
Outcome measures
| Measure |
Clopidogrel 600 mg
n=5 Participants
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 60 mg
n=10 Participants
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 30 mg
n=6 Participants
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
|---|---|---|---|
|
Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)
Baseline (ADP) (n=5, n=10, n=6)
|
536.60 Aggregation Units * minutes
Interval 453.01 to 620.19
|
601.60 Aggregation Units * minutes
Interval 489.12 to 714.08
|
459.33 Aggregation Units * minutes
Interval 369.59 to 549.07
|
|
Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)
Day 1 (ADP) (n=5, n=10, n=6)
|
248.80 Aggregation Units * minutes
Interval 133.88 to 363.72
|
90.00 Aggregation Units * minutes
Interval 74.08 to 105.92
|
118.17 Aggregation Units * minutes
Interval 79.82 to 156.51
|
|
Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)
Day 3 (ADP) (n=5, n=10, n=6)
|
347.60 Aggregation Units * minutes
Interval 97.5 to 597.7
|
140.90 Aggregation Units * minutes
Interval 96.21 to 185.59
|
134.67 Aggregation Units * minutes
Interval 100.88 to 168.46
|
|
Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)
Day 5 (ADP) (n=5, n=10, n=4)
|
428.40 Aggregation Units * minutes
Interval 265.81 to 590.99
|
231.30 Aggregation Units * minutes
Interval 173.02 to 289.58
|
296.00 Aggregation Units * minutes
Interval 164.77 to 427.23
|
|
Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)
Day 7 (ADP) (n=5, n=10, n=5)
|
478.80 Aggregation Units * minutes
Interval 338.41 to 619.19
|
316.20 Aggregation Units * minutes
Interval 257.51 to 374.89
|
295.40 Aggregation Units * minutes
Interval 229.77 to 361.03
|
|
Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)
Day 9 (ADP) (n=5, n=10, n=5)
|
529.40 Aggregation Units * minutes
Interval 381.37 to 677.43
|
549.00 Aggregation Units * minutes
Interval 439.7 to 658.3
|
484.40 Aggregation Units * minutes
Interval 316.2 to 652.6
|
|
Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)
Day 11 (ADP) (n=5, n=10, n=5)
|
555.00 Aggregation Units * minutes
Interval 431.41 to 678.59
|
500.20 Aggregation Units * minutes
Interval 426.84 to 573.56
|
564.00 Aggregation Units * minutes
Interval 439.67 to 688.33
|
|
Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)
Baseline (ADP HS) (n=5, n=10, n=6)
|
361.00 Aggregation Units * minutes
Interval 225.47 to 496.53
|
411.70 Aggregation Units * minutes
Interval 330.83 to 492.57
|
344.00 Aggregation Units * minutes
Interval 246.05 to 441.95
|
|
Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)
Day 1 (ADP HS) (n=5, n=10, n=6)
|
166.80 Aggregation Units * minutes
Interval 88.39 to 245.21
|
34.50 Aggregation Units * minutes
Interval 18.08 to 50.92
|
70.17 Aggregation Units * minutes
Interval 40.54 to 99.8
|
|
Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)
Day 3 (ADP HS) (n=5, n=10, n=6)
|
257.60 Aggregation Units * minutes
Interval 41.96 to 473.24
|
79.30 Aggregation Units * minutes
Interval 55.45 to 103.15
|
90.50 Aggregation Units * minutes
Interval 64.84 to 116.16
|
|
Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)
Day 5 (ADP HS) (n=5, n=10, n=4)
|
256.80 Aggregation Units * minutes
Interval 118.58 to 395.02
|
114.10 Aggregation Units * minutes
Interval 87.86 to 140.34
|
145.00 Aggregation Units * minutes
Interval 72.29 to 217.71
|
|
Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)
Day 7 (ADP HS) (n=5, n=10, n=5)
|
263.60 Aggregation Units * minutes
Interval 124.99 to 402.21
|
189.50 Aggregation Units * minutes
Interval 152.93 to 226.07
|
170.60 Aggregation Units * minutes
Interval 115.78 to 225.42
|
|
Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)
Day 9 (ADP HS) (n=5, n=10, n=5)
|
388.20 Aggregation Units * minutes
Interval 172.68 to 603.72
|
344.60 Aggregation Units * minutes
Interval 263.97 to 425.23
|
343.60 Aggregation Units * minutes
Interval 228.01 to 459.19
|
|
Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)
Day 11 (ADP HS) (n=5, n=10, n=5)
|
373.20 Aggregation Units * minutes
Interval 256.35 to 490.05
|
365.40 Aggregation Units * minutes
Interval 294.25 to 436.55
|
404.00 Aggregation Units * minutes
Interval 329.6 to 478.4
|
SECONDARY outcome
Timeframe: Up through 11 daysPopulation: Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.
Maximum platelet aggregation (MPA) to 5 and 20 μM ADP were assessed by LTA. This outcome measure was not analyzed due to limited sample size.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up through 11 daysPopulation: Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.
The Multiplate analyzer was used to assess platelet aggregation based on impedance aggregometry in whole blood. After adding 6.4 µM ADP (ADP test) or 6.4 µM ADP plus 9.4 nM Prostaglandin E1 (PGE1) (ADP test HS), area under the aggregation curve (AUC) was calculated. This outcome measure was not analyzed due to limited sample size.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hours post-loading dosePopulation: LD ITT population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD.
MPA to 5 and 20 μM ADP were assessed by LTA.
Outcome measures
| Measure |
Clopidogrel 600 mg
n=5 Participants
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 60 mg
n=10 Participants
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 30 mg
n=6 Participants
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
|---|---|---|---|
|
Platelet Function by LTA at 5 and 20 μM ADP
Maximum Aggregation (20 µM ADP)
|
52.60 percent aggregation
Standard Deviation 20.60
|
27.30 percent aggregation
Standard Deviation 10.86
|
31.67 percent aggregation
Standard Deviation 11.13
|
|
Platelet Function by LTA at 5 and 20 μM ADP
Maximum Aggregation (5 µM ADP)
|
39.40 percent aggregation
Standard Deviation 16.79
|
22.00 percent aggregation
Standard Deviation 11.44
|
25.50 percent aggregation
Standard Deviation 8.89
|
SECONDARY outcome
Timeframe: 24 hours post-loading dosePopulation: LD ITT Population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD.
The Multiplate analyzer was used to assess platelet aggregation based on impedance aggregometry in whole blood. After adding 6.4 µM ADP (ADP test) or 6.4 µM ADP plus 9.4 nM PGE1 (ADP test HS), area under the aggregation curve (AUC) were calculated.
Outcome measures
| Measure |
Clopidogrel 600 mg
n=5 Participants
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 60 mg
n=10 Participants
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 30 mg
n=6 Participants
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
|---|---|---|---|
|
Platelet Function by Multiplate® ADP Test and ADP Test HS
ADP Test AUC
|
248.80 aggregation units*minute
Standard Deviation 120.54
|
90.00 aggregation units*minute
Standard Deviation 27.46
|
118.17 aggregation units*minute
Standard Deviation 46.61
|
|
Platelet Function by Multiplate® ADP Test and ADP Test HS
ADP Test HS AUC
|
166.80 aggregation units*minute
Standard Deviation 82.24
|
34.50 aggregation units*minute
Standard Deviation 28.33
|
70.17 aggregation units*minute
Standard Deviation 36.02
|
Adverse Events
Clopidogrel 600 mg
Prasugrel 60 mg
Prasugrel 30 mg
Serious adverse events
| Measure |
Clopidogrel 600 mg
n=10 participants at risk
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 60 mg
n=10 participants at risk
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
Prasugrel 30 mg
n=8 participants at risk
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose \[LD\])
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/10
|
0.00%
0/10
|
12.5%
1/8 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60