Trial Outcomes & Findings for Clopidogrel to Prasugrel in Acute Coronary Syndrome (ACS) Patients (NCT NCT01115738)
NCT ID: NCT01115738
Last Updated: 2012-11-20
Results Overview
ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
282 participants
Primary outcome timeframe
6 hours after prasugrel loading dose
Results posted on
2012-11-20
Participant Flow
Participant milestones
| Measure |
Placebo and 60-mg Prasugrel
Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 60-mg Prasugrel
600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 30-mg Prasugrel
600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
|---|---|---|---|
|
Overall Study
STARTED
|
110
|
83
|
89
|
|
Overall Study
Received Any Treatment
|
109
|
79
|
88
|
|
Overall Study
Pharmacodynamic (PD) Population
|
52
|
47
|
50
|
|
Overall Study
COMPLETED
|
85
|
62
|
62
|
|
Overall Study
NOT COMPLETED
|
25
|
21
|
27
|
Reasons for withdrawal
| Measure |
Placebo and 60-mg Prasugrel
Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 60-mg Prasugrel
600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 30-mg Prasugrel
600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
18
|
15
|
17
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
9
|
Baseline Characteristics
Clopidogrel to Prasugrel in Acute Coronary Syndrome (ACS) Patients
Baseline characteristics by cohort
| Measure |
Placebo and 60-mg Prasugrel
n=52 Participants
Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 60-mg Prasugrel
n=47 Participants
600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 30-mg Prasugrel
n=50 Participants
600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
58.1 years
STANDARD_DEVIATION 9.47 • n=5 Participants
|
57.5 years
STANDARD_DEVIATION 9.12 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 8.07 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 8.86 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
India
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
9 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
10 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Region of Enrollment
Turkey
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
22 participants
n=4 Participants
|
|
Qualifying Acute Coronary Syndrome (ACS) Event
Unstable Angina
|
21 participants
n=5 Participants
|
16 participants
n=7 Participants
|
22 participants
n=5 Participants
|
59 participants
n=4 Participants
|
|
Qualifying Acute Coronary Syndrome (ACS) Event
Non-ST-elevation Myocardial Infarction
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
21 participants
n=5 Participants
|
59 participants
n=4 Participants
|
|
Qualifying Acute Coronary Syndrome (ACS) Event
ST-elevation Myocardial Infarction
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
7 participants
n=5 Participants
|
31 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 hours after prasugrel loading dosePopulation: All randomized participants who received the prasugrel LD and had at least one evaluable PRU measurement after LD.
ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.
Outcome measures
| Measure |
Placebo and 60-mg Prasugrel
n=52 Participants
Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 60-mg Prasugrel
n=47 Participants
600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 30-mg Prasugrel
n=50 Participants
600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 RM
CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 EM
CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 RM
CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
|---|---|---|---|---|---|---|
|
Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation 6 Hours After Prasugrel Loading Dose (LD)
|
57.86 PRU
Standard Error 11.86
|
35.61 PRU
Standard Error 12.36
|
53.92 PRU
Standard Error 11.74
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 2 hours and 24 hours and 72 hours after prasugrel loading dosePopulation: All randomized participants who received prasugrel LD and had at least one evaluable PRU measurement after prasugrel LD.
ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.
Outcome measures
| Measure |
Placebo and 60-mg Prasugrel
n=52 Participants
Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 60-mg Prasugrel
n=47 Participants
600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 30-mg Prasugrel
n=50 Participants
600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 RM
CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 EM
CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 RM
CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
|---|---|---|---|---|---|---|
|
Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation at Baseline, 2, 24 and 72 Hours After Prasugrel Loading Dose (LD)
Baseline
|
265.51 PRU
Standard Error 13.01
|
248.58 PRU
Standard Error 13.99
|
229.62 PRU
Standard Error 13.38
|
—
|
—
|
—
|
|
Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation at Baseline, 2, 24 and 72 Hours After Prasugrel Loading Dose (LD)
2 Hours after Prasugrel LD
|
122.55 PRU
Standard Error 17.28
|
113.10 PRU
Standard Error 18.07
|
117.10 PRU
Standard Error 17.47
|
—
|
—
|
—
|
|
Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation at Baseline, 2, 24 and 72 Hours After Prasugrel Loading Dose (LD)
24 Hours after Prasugrel LD
|
62.73 PRU
Standard Error 10.43
|
34.05 PRU
Standard Error 10.88
|
51.43 PRU
Standard Error 10.72
|
—
|
—
|
—
|
|
Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation at Baseline, 2, 24 and 72 Hours After Prasugrel Loading Dose (LD)
72 Hours after Prasugrel LD
|
56.95 PRU
Standard Error 8.40
|
48.08 PRU
Standard Error 9.09
|
60.29 PRU
Standard Error 9.05
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 72 hoursPopulation: All randomized participants who received prasugrel loading dose (LD) and had a Hematocrit measurement 72 hours after LD.
Outcome measures
| Measure |
Placebo and 60-mg Prasugrel
n=43 Participants
Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 60-mg Prasugrel
n=38 Participants
600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 30-mg Prasugrel
n=36 Participants
600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 RM
CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 EM
CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 RM
CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hematocrit
|
0.0 proportion of 1.0
Standard Deviation 0.04
|
0.0 proportion of 1.0
Standard Deviation 0.03
|
0.0 proportion of 1.0
Standard Deviation 0.03
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 72 hoursPopulation: All randomized participants who received prasugrel loading dose (LD) and had a Hemoglobin measurement 72 hours after LD.
Outcome measures
| Measure |
Placebo and 60-mg Prasugrel
n=43 Participants
Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 60-mg Prasugrel
n=38 Participants
600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 30-mg Prasugrel
n=36 Participants
600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 RM
CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 EM
CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 RM
CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hemoglobin
|
-0.9 gram per deciliter (g/dL)
Standard Deviation 1.41
|
-0.6 gram per deciliter (g/dL)
Standard Deviation 1.03
|
-0.6 gram per deciliter (g/dL)
Standard Deviation 1.04
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 2 and 6 and 24 and 72 hours after loading dosePopulation: All randomized participants who received prasugrel loading dose (LD) and had at least one evaluable PRU measurement after prasugrel LD.
Adenosine Diphosphate (ADP)-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. The internal BASE standard is an independent measurement and serves as an estimate of the participant's baseline platelet aggregation independent of P2Y12 receptor inhibition. Percent Inhibition of Platelet Aggregation=(1-\[PRU/BASE) x 100%, high numbers represent increased platelet inhibition. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.
Outcome measures
| Measure |
Placebo and 60-mg Prasugrel
n=52 Participants
Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 60-mg Prasugrel
n=47 Participants
600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 30-mg Prasugrel
n=50 Participants
600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 RM
CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 EM
CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 RM
CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
|---|---|---|---|---|---|---|
|
Percentage of Inhibition of Platelet Aggregation
Baseline
|
9.71 percentage of inhibition
Standard Error 3.44
|
13.02 percentage of inhibition
Standard Error 3.70
|
14.94 percentage of inhibition
Standard Error 3.54
|
—
|
—
|
—
|
|
Percentage of Inhibition of Platelet Aggregation
2 Hours after Prasugrel LD
|
56.04 percentage of inhibition
Standard Error 5.88
|
58.75 percentage of inhibition
Standard Error 6.16
|
54.89 percentage of inhibition
Standard Error 5.95
|
—
|
—
|
—
|
|
Percentage of Inhibition of Platelet Aggregation
6 Hours after Prasugrel LD
|
79.87 percentage of inhibition
Standard Error 3.95
|
86.77 percentage of inhibition
Standard Error 4.13
|
78.55 percentage of inhibition
Standard Error 3.93
|
—
|
—
|
—
|
|
Percentage of Inhibition of Platelet Aggregation
24 Hours after Prasugrel LD
|
77.57 percentage of inhibition
Standard Error 3.56
|
87.64 percentage of inhibition
Standard Error 3.74
|
78.56 percentage of inhibition
Standard Error 3.68
|
—
|
—
|
—
|
|
Percentage of Inhibition of Platelet Aggregation
72 Hours after Prasugrel LD
|
78.48 percentage of inhibition
Standard Error 2.95
|
83.51 percentage of inhibition
Standard Error 3.28
|
78.17 percentage of inhibition
Standard Error 3.27
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 2 and 6 and 24 and 72 hours after loading dosePopulation: All randomized participants who received prasugrel loading dose (LD) and had at least one evaluable PRU measurement after prasugrel LD.
Poor responders are those who had P2Y12 Reaction Units (PRU)≥ 240.
Outcome measures
| Measure |
Placebo and 60-mg Prasugrel
n=52 Participants
Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 60-mg Prasugrel
n=47 Participants
600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 30-mg Prasugrel
n=50 Participants
600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 RM
CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 EM
CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 RM
CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
|---|---|---|---|---|---|---|
|
Percentage of Poor Responders
2 Hours after Prasugrel LD
|
23.3 percentage of participants
|
12.8 percentage of participants
|
21.4 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Poor Responders
6 Hours after Prasugrel LD
|
11.6 percentage of participants
|
5.3 percentage of participants
|
4.4 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Poor Responders
Baseline
|
68.1 percentage of participants
|
66.7 percentage of participants
|
51.2 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Poor Responders
24 Hours after Prasugrel LD
|
9.5 percentage of participants
|
2.9 percentage of participants
|
8.8 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Poor Responders
72 Hours after Prasugrel LD
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 72 hours after prasugrel loading dosePopulation: Participants who received any treatment.
TEAE is a worsening or new occurrence of adverse event (AE) during treatment compared to baseline. A summary of serious adverse events (SAE) and other nonserious AE are located in the Reported Adverse Events section.
Outcome measures
| Measure |
Placebo and 60-mg Prasugrel
n=109 Participants
Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 60-mg Prasugrel
n=79 Participants
600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 30-mg Prasugrel
n=88 Participants
600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 RM
CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 EM
CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 RM
CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Serious Adverse Events
|
2 participants
|
8 participants
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Nonserious Adverse Events
|
37 participants
|
31 participants
|
31 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: All randomized participants who were treated with Clopidogrel and had PRU measurement at Baseline and provided a DNA sample.
CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (\*1/\*1, \*1/\*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (\*2/\*2, \*1/\*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group.
Outcome measures
| Measure |
Placebo and 60-mg Prasugrel
n=51 Participants
Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 60-mg Prasugrel
n=20 Participants
600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 30-mg Prasugrel
600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 RM
CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 EM
CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 RM
CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
|---|---|---|---|---|---|---|
|
P2Y12 Reaction Units (PRU) of Clopidogrel Treated Participants at Baseline by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - CYP2C19 Extensive Metabolizers (EM) and Reduced Metabolizers (RM)
|
243.549 PRU
Standard Error 11.244
|
240.100 PRU
Standard Error 17.955
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 hours after prasugrel loading dosePopulation: All randomized participants who received prasugrel LD and had PRU measurements 6 hours after prasugrel LD and provided a DNA sample.
CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (\*1/\*1, \*1/\*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (\*2/\*2, \*1/\*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group.
Outcome measures
| Measure |
Placebo and 60-mg Prasugrel
n=28 Participants
Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 60-mg Prasugrel
n=4 Participants
600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 30-mg Prasugrel
n=21 Participants
600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 RM
n=8 Participants
CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 EM
n=23 Participants
CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 RM
n=9 Participants
CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
|---|---|---|---|---|---|---|
|
P2Y12 Reaction Units (PRU) at 6 Hours Post-Prasugrel Loading Dose (LD) by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - Extensive Metabolizers (EM) and Reduced Metabolizers (RM)
|
39.036 PRU
Standard Error 11.397
|
47.750 PRU
Standard Error 30.153
|
20.190 PRU
Standard Error 13.160
|
23.625 PRU
Standard Error 21.321
|
36.478 PRU
Standard Error 12.575
|
24.778 PRU
Standard Error 20.102
|
Adverse Events
Placebo and 60-mg Prasugrel
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
600-mg Clopidogrel and 60-mg Prasugrel
Serious events: 8 serious events
Other events: 31 other events
Deaths: 0 deaths
600-mg Clopidogrel and 30-mg Prasugrel
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo and 60-mg Prasugrel
n=109 participants at risk
Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 60-mg Prasugrel
n=79 participants at risk
600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 30-mg Prasugrel
n=88 participants at risk
600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/109
|
1.3%
1/79 • Number of events 1
|
0.00%
0/88
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/109
|
1.3%
1/79 • Number of events 1
|
0.00%
0/88
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.92%
1/109 • Number of events 1
|
0.00%
0/79
|
0.00%
0/88
|
|
Cardiac disorders
Cardiogenic shock
|
0.92%
1/109 • Number of events 1
|
0.00%
0/79
|
0.00%
0/88
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/109
|
1.3%
1/79 • Number of events 1
|
0.00%
0/88
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/109
|
2.5%
2/79 • Number of events 2
|
0.00%
0/88
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/109
|
0.00%
0/79
|
1.1%
1/88 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/109
|
1.3%
1/79 • Number of events 1
|
0.00%
0/88
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/109
|
1.3%
1/79 • Number of events 1
|
0.00%
0/88
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/109
|
1.3%
1/79 • Number of events 1
|
0.00%
0/88
|
|
Vascular disorders
Femoral artery dissection
|
0.00%
0/109
|
1.3%
1/79 • Number of events 1
|
0.00%
0/88
|
|
Vascular disorders
Hypotension
|
0.00%
0/109
|
1.3%
1/79 • Number of events 1
|
0.00%
0/88
|
Other adverse events
| Measure |
Placebo and 60-mg Prasugrel
n=109 participants at risk
Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 60-mg Prasugrel
n=79 participants at risk
600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
600-mg Clopidogrel and 30-mg Prasugrel
n=88 participants at risk
600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/109
|
0.00%
0/79
|
2.3%
2/88 • Number of events 2
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/109
|
2.5%
2/79 • Number of events 2
|
0.00%
0/88
|
|
Gastrointestinal disorders
Constipation
|
2.8%
3/109 • Number of events 3
|
0.00%
0/79
|
1.1%
1/88 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.8%
3/109 • Number of events 3
|
2.5%
2/79 • Number of events 2
|
2.3%
2/88 • Number of events 2
|
|
General disorders
Chest pain
|
0.92%
1/109 • Number of events 1
|
1.3%
1/79 • Number of events 1
|
2.3%
2/88 • Number of events 2
|
|
Investigations
Cardiac enzymes increased
|
0.00%
0/109
|
2.5%
2/79 • Number of events 2
|
0.00%
0/88
|
|
Investigations
High density lipoprotein decreased
|
7.3%
8/109 • Number of events 8
|
8.9%
7/79 • Number of events 7
|
8.0%
7/88 • Number of events 7
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.92%
1/109 • Number of events 1
|
0.00%
0/79
|
2.3%
2/88 • Number of events 2
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
4.6%
5/109 • Number of events 5
|
5.1%
4/79 • Number of events 4
|
2.3%
2/88 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.7%
4/109 • Number of events 4
|
1.3%
1/79 • Number of events 1
|
0.00%
0/88
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.92%
1/109 • Number of events 1
|
2.5%
2/79 • Number of events 2
|
0.00%
0/88
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.5%
6/109 • Number of events 6
|
3.8%
3/79 • Number of events 3
|
6.8%
6/88 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.8%
3/109 • Number of events 3
|
1.3%
1/79 • Number of events 1
|
3.4%
3/88 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/109
|
2.5%
2/79 • Number of events 2
|
1.1%
1/88 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/109
|
0.00%
0/79
|
2.3%
2/88 • Number of events 2
|
|
Nervous system disorders
Headache
|
2.8%
3/109 • Number of events 3
|
5.1%
4/79 • Number of events 4
|
4.5%
4/88 • Number of events 4
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/109
|
3.8%
3/79 • Number of events 3
|
0.00%
0/88
|
|
Vascular disorders
Hypertension
|
0.00%
0/109
|
0.00%
0/79
|
2.3%
2/88 • Number of events 2
|
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