Trial Outcomes & Findings for Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event (NCT NCT00356135)
NCT ID: NCT00356135
Last Updated: 2010-11-03
Results Overview
Maximum platelet aggregation (MPA) to 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
139 participants
Primary outcome timeframe
1 week after first dose of randomized study drug
Results posted on
2010-11-03
Participant Flow
30-330 days after acute coronary syndrome event, patients participated in 2 week open-label clopidogrel phase. Patients were then randomized to either 22-26 hour loading doses of: 60-mg prasugrel, 10-mg prasugrel, or 75-mg clopidogrel, then continued 2-week maintenance phase of 10-mg prasugrel, 10-mg prasugrel, or 75-mg clopidogrel, respectively.
Participant milestones
| Measure |
Prasgurel 10/10 mg
Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
Clopidogrel 75/75 mg
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
|
Prasugrel 60/10 mg
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
44
|
|
Overall Study
COMPLETED
|
43
|
46
|
39
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
5
|
Reasons for withdrawal
| Measure |
Prasgurel 10/10 mg
Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
Clopidogrel 75/75 mg
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
|
Prasugrel 60/10 mg
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
1
|
|
Overall Study
Subject non-compliance
|
1
|
1
|
3
|
Baseline Characteristics
Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event
Baseline characteristics by cohort
| Measure |
Prasugrel 10/10 mg
n=47 Participants
Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
Clopidogrel 75/75 mg
n=48 Participants
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
|
Prasugrel 60/10 mg
n=44 Participants
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
57.6 years
STANDARD_DEVIATION 8.18 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 8.93 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 9.16 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 8.73 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
39 participants
n=5 Participants
|
30 participants
n=7 Participants
|
37 participants
n=5 Participants
|
106 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African
|
7 participants
n=5 Participants
|
13 participants
n=7 Participants
|
6 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
1 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
48 participants
n=7 Participants
|
44 participants
n=5 Participants
|
139 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 week after first dose of randomized study drugPopulation: The primary analysis population was the pharmacodynamic (PD) population which included all randomized participants who had blood draws for MPA at 1 week after randomization who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.
Maximum platelet aggregation (MPA) to 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA).
Outcome measures
| Measure |
Prasugrel 10/10 mg
n=34 Participants
Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
Clopidogrel 75/75 mg
n=31 Participants
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
|
Prasugrel 60/10 mg
n=30 Participants
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
|---|---|---|---|
|
Maximum Platelet Aggregation (MPA) to 20 Micromolar (uM) Adenosine Diphosphase (ADP)
|
41.1 percent maximum platelet aggregation (%)
Standard Error 1.99
|
55.0 percent maximum platelet aggregation (%)
Standard Error 2.09
|
41.0 percent maximum platelet aggregation (%)
Standard Error 2.00
|
SECONDARY outcome
Timeframe: 2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drugPopulation: Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.
Maximum platelet aggregation (MPA) to 5 and 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA).
Outcome measures
| Measure |
Prasugrel 10/10 mg
n=36 Participants
Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
Clopidogrel 75/75 mg
n=33 Participants
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
|
Prasugrel 60/10 mg
n=31 Participants
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
|---|---|---|---|
|
Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
2 Hour (20 uM ADP)
|
49.46 percent maximum platelet aggregation (%)
Standard Deviation 21.243 • Interval -8.22 to 3.35
|
48.07 percent maximum platelet aggregation (%)
Standard Deviation 17.728 • Interval -29.3 to -17.51
|
26.65 percent maximum platelet aggregation (%)
Standard Deviation 10.875
|
|
Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
24 Hour (20 uM ADP)
|
52.29 percent maximum platelet aggregation (%)
Standard Deviation 16.511 • Interval -8.82 to 0.32
|
53.80 percent maximum platelet aggregation (%)
Standard Deviation 14.504 • Interval -33.2 to -23.94
|
27.36 percent maximum platelet aggregation (%)
Standard Deviation 10.812
|
|
Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
1 Week (20 uM ADP)
|
42.95 percent maximum platelet aggregation (%)
Standard Deviation 14.963 • Interval -19.96 to -9.65
|
53.80 percent maximum platelet aggregation (%)
Standard Deviation 14.878 • Interval -19.87 to -9.32
|
40.64 percent maximum platelet aggregation (%)
Standard Deviation 10.182
|
|
Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
2 Week (20 uM ADP)
|
40.84 percent maximum platelet aggregation (%)
Standard Deviation 13.359 • Interval -20.3 to -9.22
|
52.25 percent maximum platelet aggregation (%)
Standard Deviation 16.856 • Interval -20.59 to -9.22
|
38.61 percent maximum platelet aggregation (%)
Standard Deviation 13.373
|
|
Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
2 Hour (5 uM ADP)
|
37.87 percent maximum platelet aggregation (%)
Standard Deviation 16.547 • Interval -5.85 to 3.14
|
37.25 percent maximum platelet aggregation (%)
Standard Deviation 12.579 • Interval -21.55 to -12.37
|
19.97 percent maximum platelet aggregation (%)
Standard Deviation 11.263
|
|
Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
24 Hour (5 uM ADP)
|
38.84 percent maximum platelet aggregation (%)
Standard Deviation 14.841 • Interval -8.58 to 0.42
|
40.88 percent maximum platelet aggregation (%)
Standard Deviation 14.540 • Interval -24.81 to -15.64
|
20.94 percent maximum platelet aggregation (%)
Standard Deviation 11.476
|
|
Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
1 Week (5 uM ADP)
|
32.44 percent maximum platelet aggregation (%)
Standard Deviation 11.739 • Interval -17.21 to -7.5
|
41.94 percent maximum platelet aggregation (%)
Standard Deviation 14.436 • Interval -15.79 to -5.79
|
31.45 percent maximum platelet aggregation (%)
Standard Deviation 11.446
|
|
Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
2 Week (5 uM ADP)
|
30.18 percent maximum platelet aggregation (%)
Standard Deviation 11.444 • Interval -17.41 to -7.72
|
41.05 percent maximum platelet aggregation (%)
Standard Deviation 13.570 • Interval -16.8 to -6.82
|
28.64 percent maximum platelet aggregation (%)
Standard Deviation 13.534
|
SECONDARY outcome
Timeframe: End of 14 day open labelPopulation: Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA. Grouped according to clopidogrel use at time of ACS event and no clopidogrel use at time of ACS event.
Data provided are the MPA to 20 micromolar ADP while taking clopidogrel (measurement taken at end of the 14 day open label phase) grouped by subjects who were taking clopidogrel at the time of the qualifying ACS event compared with subjects who were not taking clopidogrel at the time of the qualifying ACS event.
Outcome measures
| Measure |
Prasugrel 10/10 mg
n=20 Participants
Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
Clopidogrel 75/75 mg
n=75 Participants
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
|
Prasugrel 60/10 mg
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
|---|---|---|---|
|
Maximum Platelet Aggregation (MPA) to 20 uM ADP According to Clopidogrel Use at Time of Qualifying Acute Coronary Syndrome (ACS) Event
|
60.73 percent maximum platelet aggregation (%)
Standard Deviation 18.729
|
55.53 percent maximum platelet aggregation (%)
Standard Deviation 14.356
|
—
|
SECONDARY outcome
Timeframe: 2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drugPopulation: Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.
Residual platelet aggregation after the addition 5 and 20 micromolar ADP as measured with light transmittance aggregometry (LTA).
Outcome measures
| Measure |
Prasugrel 10/10 mg
n=36 Participants
Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
Clopidogrel 75/75 mg
n=33 Participants
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
|
Prasugrel 60/10 mg
n=31 Participants
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
|---|---|---|---|
|
Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
2 Hour (20 uM ADP)
|
32.06 percent residual platelet aggregation
Standard Deviation 24.462 • Interval -9.5 to 3.37
|
28.21 percent residual platelet aggregation
Standard Deviation 21.792 • Interval -33.4 to -20.33
|
5.10 percent residual platelet aggregation
Standard Deviation 7.814
|
|
Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
24 Hour (20 uM ADP)
|
32.97 percent residual platelet aggregation
Standard Deviation 21.858 • Interval -13.04 to -1.6
|
35.16 percent residual platelet aggregation
Standard Deviation 19.379 • Interval -39.99 to -28.42
|
4.70 percent residual platelet aggregation
Standard Deviation 5.688
|
|
Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
1 Week (20 uM ADP)
|
22.92 percent residual platelet aggregation
Standard Deviation 17.961 • Interval -25.58 to -11.09
|
34.45 percent residual platelet aggregation
Standard Deviation 21.752 • Interval -27.09 to -12.26
|
17.94 percent residual platelet aggregation
Standard Deviation 12.961
|
|
Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
2 Week (20 uM ADP)
|
18.89 percent residual platelet aggregation
Standard Deviation 14.401 • Interval -28.42 to -14.77
|
34.56 percent residual platelet aggregation
Standard Deviation 19.515 • Interval -29.61 to -15.63
|
15.17 percent residual platelet aggregation
Standard Deviation 15.127
|
|
Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
2 Hour (5 uM ADP)
|
18.83 percent residual platelet aggregation
Standard Deviation 17.574 • Interval -3.11 to 6.38
|
14.84 percent residual platelet aggregation
Standard Deviation 12.767 • Interval -15.92 to -6.24
|
4.17 percent residual platelet aggregation
Standard Deviation 4.878
|
|
Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
24 Hour (5 uM ADP)
|
19.18 percent residual platelet aggregation
Standard Deviation 16.448 • Interval -8.31 to 1.74
|
19.66 percent residual platelet aggregation
Standard Deviation 14.672 • Interval -20.98 to -10.75
|
4.45 percent residual platelet aggregation
Standard Deviation 4.545
|
|
Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
1 Week (5 uM ADP)
|
11.11 percent residual platelet aggregation
Standard Deviation 10.325 • Interval -18.81 to -7.32
|
21.57 percent residual platelet aggregation
Standard Deviation 18.829 • Interval -17.91 to -6.09
|
9.94 percent residual platelet aggregation
Standard Deviation 10.370
|
|
Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
2 Week (5 uM ADP)
|
10.03 percent residual platelet aggregation
Standard Deviation 9.247 • Interval -15.64 to -6.32
|
19.28 percent residual platelet aggregation
Standard Deviation 14.824 • Interval -14.67 to -5.09
|
9.43 percent residual platelet aggregation
Standard Deviation 8.621
|
SECONDARY outcome
Timeframe: 1 week after randomized study drugPopulation: Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.
Correlation Coefficient comparing the Accumetrics VerifyNow™ P2Y12 device with light transmittance aggregometry (LTA) for monitoring platelet aggregation.
Outcome measures
| Measure |
Prasugrel 10/10 mg
n=36 Participants
Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
Clopidogrel 75/75 mg
n=33 Participants
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
|
Prasugrel 60/10 mg
n=31 Participants
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
|---|---|---|---|
|
Correlation Coefficent of Verify Now™ P2Y12 Assay Values to Maximum Platelet Aggregation (MPA) and Residual Platelet Aggregation (RPA) to 20 uM ADP at 1 Week
MPA (20 uM ADP) at 1 week
|
0.564 correlation coefficient
|
0.426 correlation coefficient
|
0.439 correlation coefficient
|
|
Correlation Coefficent of Verify Now™ P2Y12 Assay Values to Maximum Platelet Aggregation (MPA) and Residual Platelet Aggregation (RPA) to 20 uM ADP at 1 Week
RPA (20 uM ADP) at 1 week
|
0.640 correlation coefficient
|
0.425 correlation coefficient
|
0.547 correlation coefficient
|
SECONDARY outcome
Timeframe: End of 14 day open label (baseline); 24 Hours, 7 days, 14 days after first dose of randomized drugPopulation: Safety Population - all randomized participants.
Bleeding events were classified as Major Bleeding, Minor Bleeding, or Insignificant according to TIMI criteria. Major Bleeding: any intracranial hemorrhage OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in Hgb of ≥3 gm/dL but \<5 gm/dL from baseline. Insignificant Bleeding: any bleeding event that does not meet criteria for a Major or Minor Bleed.
Outcome measures
| Measure |
Prasugrel 10/10 mg
n=47 Participants
Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
Clopidogrel 75/75 mg
n=48 Participants
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
|
Prasugrel 60/10 mg
n=44 Participants
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
|---|---|---|---|
|
Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Any Bleeding at Any Time During Randomized Period
|
4 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Baseline: Any Bleeding
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Baseline: Insignificant Bleeding
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Baseline: Minor Bleeding
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Baseline: Major Bleeding
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Hour 24: Any Bleeding
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Hour 24: Insignificant Bleeding
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Hour 24: Minor Bleeding
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Hour 24: Major Bleeding
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Day 7: Any Bleeding
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Day 7: Insignificant Bleeding
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Day 7: Minor Bleeding
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Day 7: Major Bleeding
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Day 14: Any Bleeding
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Day 14: Insignificant Bleeding
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Day 14: Minor Bleeding
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
Day 14: Major Bleeding
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Prasgurel 10/10 mg
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Clopidogrel 75/75 mg
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Prasugrel 60/10 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prasgurel 10/10 mg
n=47 participants at risk
Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
Clopidogrel 75/75 mg
n=48 participants at risk
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
|
Prasugrel 60/10 mg
n=44 participants at risk
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
|---|---|---|---|
|
General disorders
Chest pain
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
0.00%
0/44
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
0.00%
0/44
|
|
Nervous system disorders
Syncope
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
0.00%
0/44
|
Other adverse events
| Measure |
Prasgurel 10/10 mg
n=47 participants at risk
Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
Clopidogrel 75/75 mg
n=48 participants at risk
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
|
Prasugrel 60/10 mg
n=44 participants at risk
Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
2.1%
1/47 • Number of events 2
|
0.00%
0/48
|
0.00%
0/44
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
Cardiac disorders
Cardiac flutter
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
0.00%
0/44
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
Cardiac disorders
Palpitations
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
Eye disorders
Eye pain
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/47
|
0.00%
0/48
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/47
|
0.00%
0/48
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
4.3%
2/47 • Number of events 2
|
0.00%
0/48
|
0.00%
0/44
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/47
|
4.2%
2/48 • Number of events 2
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Faeces hard
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
0.00%
0/44
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
General disorders
Chest discomfort
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/47
|
0.00%
0/48
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Fatigue
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Feeling jittery
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
General disorders
Oedema peripheral
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
Immune system disorders
Hypersensitivity
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
0.00%
0/44
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
1/47 • Number of events 1
|
6.2%
3/48 • Number of events 4
|
0.00%
0/44
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/47
|
6.2%
3/48 • Number of events 4
|
0.00%
0/44
|
|
Injury, poisoning and procedural complications
Contusion
|
8.5%
4/47 • Number of events 6
|
6.2%
3/48 • Number of events 4
|
2.3%
1/44 • Number of events 1
|
|
Injury, poisoning and procedural complications
Head injury
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
0.00%
0/44
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
Investigations
Blood glucose increased
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
1/47 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
0.00%
0/44
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/47
|
2.1%
1/48 • Number of events 2
|
0.00%
0/44
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
2.1%
1/47 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/47
|
4.2%
2/48 • Number of events 3
|
0.00%
0/44
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/47
|
0.00%
0/48
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
Nervous system disorders
Headache
|
2.1%
1/47 • Number of events 1
|
8.3%
4/48 • Number of events 4
|
0.00%
0/44
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/47
|
4.2%
2/48 • Number of events 2
|
0.00%
0/44
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
Psychiatric disorders
Nicotine dependence
|
0.00%
0/47
|
2.1%
1/48 • Number of events 2
|
2.3%
1/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/47
|
2.1%
1/48 • Number of events 2
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
6.8%
3/44 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
0.00%
0/44
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.1%
1/47 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
0.00%
0/44
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
0.00%
0/44
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
0.00%
0/44
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/47
|
0.00%
0/48
|
4.5%
2/44 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
0.00%
0/44
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
0.00%
0/47
|
0.00%
0/48
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
0.00%
0/44
|
|
Vascular disorders
Flushing
|
0.00%
0/47
|
0.00%
0/48
|
2.3%
1/44 • Number of events 2
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/47
|
2.1%
1/48 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Hot flush
|
2.1%
1/47 • Number of events 1
|
0.00%
0/48
|
0.00%
0/44
|
|
Vascular disorders
Hypertension
|
0.00%
0/47
|
4.2%
2/48 • Number of events 2
|
0.00%
0/44
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60