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Study to Learn When Platelets Return to Normal After One Loading Dose of Anti-platelet Drugs in Patients With Symptoms of Acute Coronary Syndromes

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ClinicalTrials.gov Identifier: NCT01107899
Recruitment Status : Terminated (Terminated due to Enrollment futility)
First Posted : April 21, 2010
Results First Posted : January 12, 2012
Last Update Posted : March 9, 2012
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Coronary Syndromes
Interventions Drug: clopidogrel
Drug: prasugrel
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clopidogrel 600 mg Prasugrel 60 mg Prasugrel 30 mg
Hide Arm/Group Description Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD]) Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD]) Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
Period Title: Overall Study
Started 10 10 9
Received at Least One Dose of Study Drug 10 10 8
Loading Dose (LD) Intent to Treat (ITT) 5 [1] 10 [1] 6 [1]
ITT Washout Population 5 [2] 10 [2] 6 [2]
Primary Washout Population 5 [3] 10 [3] 4 [3]
Completed 5 10 5
Not Completed 5 0 4
Reason Not Completed
Physician Decision             5             0             3
Withdrawal by Subject             0             0             1
[1]
Received LD and had evaluable pharmacodynamic (PD) measurements 24-hours post-LD.
[2]
ITT Washout Population (WP): Received LD, had evaluable baseline PD data (pre-LD) and post-LD.
[3]
Primary WP: Completed study with no missed visits, had evaluable PD data through Day 11.
Arm/Group Title Clopidogrel 600 mg Prasugrel 60 mg Prasugrel 30 mg Total
Hide Arm/Group Description Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD]) Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD]) Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD]) Total of all reporting groups
Overall Number of Baseline Participants 10 10 9 29
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 9 participants 29 participants
66.9  (8.54) 65.6  (6.56) 61.5  (10.01) 64.8  (8.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 9 participants 29 participants
Female
1
  10.0%
2
  20.0%
2
  22.2%
5
  17.2%
Male
9
  90.0%
8
  80.0%
7
  77.8%
24
  82.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 10 participants 10 participants 9 participants 29 participants
10 10 9 29
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 10 participants 10 participants 9 participants 29 participants
10 10 9 29
1.Primary Outcome
Title Percentage of Participants Returning to Baseline Platelet Function
Hide Description 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.
Time Frame Days 3, 5, 7, 9, and 11
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Clopidogrel 600 mg Prasugrel 60 mg Prasugrel 30 mg
Hide Arm/Group Description:
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
Overall Number of Participants Analyzed 5 10 4
Measure Type: Number
Unit of Measure: percentage of participants
Day 3 60.0 0 0
Day 5 80.0 10.0 0
Day 7 100.0 60.0 100.0
Day 9 100.0 100.0 100.0
Day 11 100.0 100.0 100.0
2.Secondary Outcome
Title The Day on Which 50%, 75% and 90% of Subjects Return to Baseline Platelet Function Following a Single LD of 30-mg or 60-mg Prasugrel or 600-mg Clopidogrel
Hide Description This outcome measure was not analyzed due to the limited sample size.
Time Frame Up through 11 days
Hide Outcome Measure Data
Hide Analysis Population Description
Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.
Arm/Group Title Clopidogrel 600 mg Prasugrel 60 mg Prasugrel 30 mg
Hide Arm/Group Description:
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title The Day When the Proportion of Participants Who Return to Baseline Platelet Function in the 30-mg and 60-mg Prasugrel Groups is Similar to the 600-mg Clopidogrel Group at Day 5 and Day 7
Hide Description 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.
Time Frame Up through 11 days
Hide Outcome Measure Data
Hide Analysis Population Description
Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.
Arm/Group Title Prasugrel 60 mg Prasugrel 30 mg
Hide Arm/Group Description:
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Days to the Return of Baseline Platelet Function Following One Loading Dose (LD)
Hide Description 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.
Time Frame Up through 11 days
Hide Outcome Measure Data
Hide Analysis Population Description
Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.
Arm/Group Title Clopidogrel 600 mg Prasugrel 60 mg Prasugrel 30 mg
Hide Arm/Group Description:
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Effect of Initial Inhibition of Platelet Aggregation on the Day to Return to Baseline Platelet Function: VN-PRU
Hide Description 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%.
Time Frame Up through 11 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Treatments
Hide Arm/Group Description:

Clopidogrel 600 mg taken orally, day one, single dose Prasugrel 30 and 60 mg taken orally, day one, single dose

All treatments were combined into one group.

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: days
20% Initial Inhibition 3.2
40% Initial Inhibition 4.6
60% Initial Inhibition 6.0
80% Initial Inhibition 7.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Treatments
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for the overall effect of initial inhibition on the day to return to baseline platelet function.
Method Regression, Linear
Comments [Not Specified]
6.Secondary Outcome
Title Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hrs Post-LD) by VN-PRU
Hide Description 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.
Time Frame Up through 11 days
Hide Outcome Measure Data
Hide Analysis Population Description
Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.
Arm/Group Title Clopidogrel 600 mg Prasugrel 60 mg Prasugrel 30 mg
Hide Arm/Group Description:
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Platelet Function 24 Hours Post Loading Dose
Hide Description PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of ADP-stimulated platelet aggregation.
Time Frame 24 hours post-loading dose
Hide Outcome Measure Data
Hide Analysis Population Description
LD ITT population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD.
Arm/Group Title Clopidogrel 600 mg Prasugrel 60 mg Prasugrel 30 mg
Hide Arm/Group Description:
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
Overall Number of Participants Analyzed 5 10 6
Mean (Standard Deviation)
Unit of Measure: P2Y12 Reaction Units (PRU)
193.0  (83.58) 32.5  (20.79) 70.0  (56.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clopidogrel 600 mg, Prasugrel 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Clopidogrel 600 mg, Prasugrel 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Prasugrel 60 mg, Prasugrel 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method ANCOVA
Comments p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.
8.Secondary Outcome
Title Percentage of Poor Pharmacodynamic Responders by Platelet Aggregation at 24 Hours Post-LD
Hide Description Platelet aggregation was assessed by Accumetrics Verify Now™ P2Y12, and poor responders were those with PRU greater than or equal to 230.
Time Frame 24 hours post-loading dose
Hide Outcome Measure Data
Hide Analysis Population Description
LD ITT Population: All randomized participants who received an LD with evaluable PD measurements.
Arm/Group Title Clopidogrel 600 mg Prasugrel 60 mg Prasugrel 30 mg
Hide Arm/Group Description:
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
Overall Number of Participants Analyzed 5 10 6
Measure Type: Number
Unit of Measure: percentage of participants
40.0 0 0
9.Secondary Outcome
Title Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)
Hide Description Initial inhibition of platelet aggregation was measured by LTA at 5 and 20 μM ADP. Maximum platelet aggregation (MPA) is reported by day.
Time Frame Up through 11 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Clopidogrel 600 mg Prasugrel 60 mg Prasugrel 30 mg
Hide Arm/Group Description:
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
Overall Number of Participants Analyzed 5 10 6
Mean (90% Confidence Interval)
Unit of Measure: percent platelet aggregation
Baseline (20 μM ADP) (n=5, n=10, n=6)
68.00
(61.82 to 74.18)
72.70
(65.31 to 80.09)
76.33
(66.76 to 85.91)
Day 1 (20 μM ADP) (n=5, n=10, n=6)
52.60
(32.96 to 72.24)
27.30
(21.00 to 33.60)
31.67
(22.51 to 40.82)
Day 3 (20 μM ADP) (n=5, n=10, n=6)
56.00
(40.25 to 71.75)
42.50
(37.69 to 47.31)
46.33
(33.38 to 59.28)
Day 5 (20 μM ADP) (n=5, n=10, n=4)
70.40
(59.41 to 81.39)
47.00
(42.50 to 51.50)
58.25
(41.24 to 75.26)
Day 7 (20 μM ADP) (n=5, n=10, n=5)
71.00
(53.46 to 88.54)
58.30
(53.14 to 63.46)
73.20
(55.55 to 90.85)
Day 9 (20 μM ADP) (n=5, n=10, n=5)
62.40
(41.97 to 82.83)
62.00
(52.20 to 71.80)
68.60
(59.44 to 77.76)
Day 11 (20 μM ADP) (n=5, n=10, n=5)
72.00
(59.59 to 84.41)
65.20
(58.11 to 72.29)
63.80
(33.21 to 94.39)
Baseline (5 μM ADP) (n=5, n=10, n=6)
64.40
(60.21 to 68.59)
62.60
(55.76 to 69.44)
70.67
(65.42 to 75.91)
Day 1 (5 μM ADP) (n=5, n=10, n=6)
39.40
(23.40 to 55.40)
22.00
(15.37 to 28.63)
25.50
(18.18 to 32.82)
Day 3 (5 μM ADP) (n=5, n=10, n=6)
50.20
(36.31 to 64.09)
32.80
(28.73 to 36.87)
48.67
(38.85 to 58.48)
Day 5 (5 μM ADP) (n=5, n=10, n=4)
64.20
(48.17 to 80.23)
39.50
(34.26 to 44.74)
53.25
(38.23 to 68.27)
Day 7 (5 μM ADP) (n=5, n=10, n=5)
60.40
(40.90 to 79.90)
52.40
(44.95 to 59.85)
65.40
(46.91 to 83.89)
Day 9 (5 μM ADP) (n=5, n=10, n=5)
58.40
(35.53 to 81.27)
56.00
(46.46 to 65.54)
60.00
(51.55 to 68.45)
Day 11 (5 μM ADP) (n=5, n=10, n=5)
61.80
(50.53 to 73.07)
58.90
(51.85 to 65.95)
56.00
(29.54 to 82.46)
10.Secondary Outcome
Title Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)
Hide Description 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).
Time Frame Up through 11 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Clopidogrel 600 mg Prasugrel 60 mg Prasugrel 30 mg
Hide Arm/Group Description:
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
Overall Number of Participants Analyzed 5 10 6
Mean (90% Confidence Interval)
Unit of Measure: Aggregation Units * minutes
Baseline (ADP) (n=5, n=10, n=6)
536.60
(453.01 to 620.19)
601.60
(489.12 to 714.08)
459.33
(369.59 to 549.07)
Day 1 (ADP) (n=5, n=10, n=6)
248.80
(133.88 to 363.72)
90.00
(74.08 to 105.92)
118.17
(79.82 to 156.51)
Day 3 (ADP) (n=5, n=10, n=6)
347.60
(97.50 to 597.70)
140.90
(96.21 to 185.59)
134.67
(100.88 to 168.46)
Day 5 (ADP) (n=5, n=10, n=4)
428.40
(265.81 to 590.99)
231.30
(173.02 to 289.58)
296.00
(164.77 to 427.23)
Day 7 (ADP) (n=5, n=10, n=5)
478.80
(338.41 to 619.19)
316.20
(257.51 to 374.89)
295.40
(229.77 to 361.03)
Day 9 (ADP) (n=5, n=10, n=5)
529.40
(381.37 to 677.43)
549.00
(439.70 to 658.30)
484.40
(316.20 to 652.60)
Day 11 (ADP) (n=5, n=10, n=5)
555.00
(431.41 to 678.59)
500.20
(426.84 to 573.56)
564.00
(439.67 to 688.33)
Baseline (ADP HS) (n=5, n=10, n=6)
361.00
(225.47 to 496.53)
411.70
(330.83 to 492.57)
344.00
(246.05 to 441.95)
Day 1 (ADP HS) (n=5, n=10, n=6)
166.80
(88.39 to 245.21)
34.50
(18.08 to 50.92)
70.17
(40.54 to 99.80)
Day 3 (ADP HS) (n=5, n=10, n=6)
257.60
(41.96 to 473.24)
79.30
(55.45 to 103.15)
90.50
(64.84 to 116.16)
Day 5 (ADP HS) (n=5, n=10, n=4)
256.80
(118.58 to 395.02)
114.10
(87.86 to 140.34)
145.00
(72.29 to 217.71)
Day 7 (ADP HS) (n=5, n=10, n=5)
263.60
(124.99 to 402.21)
189.50
(152.93 to 226.07)
170.60
(115.78 to 225.42)
Day 9 (ADP HS) (n=5, n=10, n=5)
388.20
(172.68 to 603.72)
344.60
(263.97 to 425.23)
343.60
(228.01 to 459.19)
Day 11 (ADP HS) (n=5, n=10, n=5)
373.20
(256.35 to 490.05)
365.40
(294.25 to 436.55)
404.00
(329.60 to 478.40)
11.Secondary Outcome
Title Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hours Post-LD) by LTA (5 and 20 μM ADP)
Hide Description 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.
Time Frame Up through 11 days
Hide Outcome Measure Data
Hide Analysis Population Description
Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.
Arm/Group Title Clopidogrel 600 mg Prasugrel 60 mg Prasugrel 30 mg
Hide Arm/Group Description:
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hrs Post-LD) by Multiplate® ADP Test and ADP Test High Sensitivity (HS)
Hide Description 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.
Time Frame Up through 11 days
Hide Outcome Measure Data
Hide Analysis Population Description
Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.
Arm/Group Title Clopidogrel 600 mg Prasugrel 60 mg Prasugrel 30 mg
Hide Arm/Group Description:
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Platelet Function by LTA at 5 and 20 μM ADP
Hide Description MPA to 5 and 20 μM ADP were assessed by LTA.
Time Frame 24 hours post-loading dose
Hide Outcome Measure Data
Hide Analysis Population Description
LD ITT population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD.
Arm/Group Title Clopidogrel 600 mg Prasugrel 60 mg Prasugrel 30 mg
Hide Arm/Group Description:
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
Overall Number of Participants Analyzed 5 10 6
Mean (Standard Deviation)
Unit of Measure: percent aggregation
Maximum Aggregation (20 µM ADP) 52.60  (20.60) 27.30  (10.86) 31.67  (11.13)
Maximum Aggregation (5 µM ADP) 39.40  (16.79) 22.00  (11.44) 25.50  (8.89)
14.Secondary Outcome
Title Platelet Function by Multiplate® ADP Test and ADP Test HS
Hide Description 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.
Time Frame 24 hours post-loading dose
Hide Outcome Measure Data
Hide Analysis Population Description
LD ITT Population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD.
Arm/Group Title Clopidogrel 600 mg Prasugrel 60 mg Prasugrel 30 mg
Hide Arm/Group Description:
Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
Overall Number of Participants Analyzed 5 10 6
Mean (Standard Deviation)
Unit of Measure: aggregation units*minute
ADP Test AUC 248.80  (120.54) 90.00  (27.46) 118.17  (46.61)
ADP Test HS AUC 166.80  (82.24) 34.50  (28.33) 70.17  (36.02)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clopidogrel 600 mg Prasugrel 60 mg Prasugrel 30 mg
Hide Arm/Group Description Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD]) Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD]) Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
All-Cause Mortality
Clopidogrel 600 mg Prasugrel 60 mg Prasugrel 30 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Clopidogrel 600 mg Prasugrel 60 mg Prasugrel 30 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)      1/8 (12.50%)    
Respiratory, thoracic and mediastinal disorders       
Pulmonary oedema  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clopidogrel 600 mg Prasugrel 60 mg Prasugrel 30 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)      0/8 (0.00%)    
Trial was terminated early due to enrollment futility which resulted in limited data and the inability to analyze some outcome measures.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01107899     History of Changes
Other Study ID Numbers: 11983
H7T-MC-TACM ( Other Identifier: Eli Lilly and Company )
First Submitted: April 19, 2010
First Posted: April 21, 2010
Results First Submitted: December 1, 2011
Results First Posted: January 12, 2012
Last Update Posted: March 9, 2012