Trial Outcomes & Findings for A Comparison of Antiplatelet Therapies in Asian Subjects With Acute Coronary Syndrome (NCT NCT00830960)
NCT ID: NCT00830960
Last Updated: 2011-11-02
Results Overview
ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition. Observed PRU values are presented with statistical comparisons of difference in least squares mean (LS mean) PRU values between prasugrel and clopidogrel. Efficacy analyses are analyzed and presented separately for the LD and maintenance dose (MD) phase.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
720 participants
Primary outcome timeframe
At 4 hours following LD administration
Results posted on
2011-11-02
Participant Flow
This study had 4 treatment arms and had 2 cohorts; a Primary Cohort (≥60 kilograms \[kg\] and age \<75 years) and a Low Weight/Elderly cohort (\<60 kg or age ≥75 years). Randomization was stratified by country, cohort and anticipated glycoprotein (GP) IIb/IIIa inhibitor use.
One participant who was enrolled based on weight \>60 kg was not assigned to primary cohort due to no weight entered in case report form. Low Weight/Elderly Cohort was only assigned to prasugrel 30-mg loading dose (LD)/5-mg maintenance dose (MD) or clopidogrel 300-mg LD/75-mg MD due to evidence of increased bleeding risk for these populations.
Participant milestones
| Measure |
Prasugrel 60/10 Primary
Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age \<75 years)
|
Prasugrel 30/7.5 Primary
Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \<75 years)
|
Prasugrel 30/5 Primary
Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \<75 years)
|
Clopidogrel 300/75 Primary
Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \<75 years)
|
Prasugrel 30/5 Low Weight/Elderly
Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)
|
Clopidogrel 300/75 Low Weight/Elderly
Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
124
|
124
|
137
|
138
|
96
|
100
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
117
|
122
|
133
|
135
|
91
|
93
|
|
Overall Study
COMPLETED
|
91
|
96
|
108
|
106
|
64
|
63
|
|
Overall Study
NOT COMPLETED
|
33
|
28
|
29
|
32
|
32
|
37
|
Reasons for withdrawal
| Measure |
Prasugrel 60/10 Primary
Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age \<75 years)
|
Prasugrel 30/7.5 Primary
Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \<75 years)
|
Prasugrel 30/5 Primary
Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \<75 years)
|
Clopidogrel 300/75 Primary
Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \<75 years)
|
Prasugrel 30/5 Low Weight/Elderly
Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)
|
Clopidogrel 300/75 Low Weight/Elderly
Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
5
|
4
|
3
|
2
|
6
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
19
|
19
|
18
|
23
|
16
|
21
|
|
Overall Study
Sponsor Decision
|
1
|
2
|
3
|
4
|
5
|
7
|
|
Overall Study
No study drug received
|
7
|
2
|
4
|
3
|
5
|
7
|
Baseline Characteristics
A Comparison of Antiplatelet Therapies in Asian Subjects With Acute Coronary Syndrome
Baseline characteristics by cohort
| Measure |
Prasugrel 60/10 Primary
n=117 Participants
Study treatment of prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age \<75 years)
Reporting groups for Baseline Characteristics do not include all randomized participants (n=720), but includes all randomized participants who received at least 1 dose of study drug.
|
Prasugrel 30/7.5 Primary
n=122 Participants
Study treatment of prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \<75 years)
|
Prasugrel 30/5 Primary
n=133 Participants
Study treatment of prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age \<75 years)
|
Clopidogrel 300/75 Primary
n=135 Participants
Study treatment of clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age \<75 years)
|
Prasugrel 30/5 Low Weight/Elderly
n=91 Participants
Study treatment of prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)
|
Clopidogrel 300/75 Low Weight/Elderly
n=93 Participants
Study treatment of clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)
|
Total
n=691 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age Continuous
Mean Age Overall
|
58.3 years
STANDARD_DEVIATION 9.83 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 9.47 • n=7 Participants
|
57.2 years
STANDARD_DEVIATION 10.49 • n=5 Participants
|
58.3 years
STANDARD_DEVIATION 8.95 • n=4 Participants
|
68.5 years
STANDARD_DEVIATION 9.74 • n=21 Participants
|
69.1 years
STANDARD_DEVIATION 12.08 • n=10 Participants
|
60.8 years
STANDARD_DEVIATION 11.13 • n=115 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
48 Participants
n=10 Participants
|
174 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
45 Participants
n=10 Participants
|
517 Participants
n=115 Participants
|
|
Region of Enrollment
China
|
85 participants
n=5 Participants
|
85 participants
n=7 Participants
|
93 participants
n=5 Participants
|
95 participants
n=4 Participants
|
64 participants
n=21 Participants
|
61 participants
n=10 Participants
|
483 participants
n=115 Participants
|
|
Region of Enrollment
Korea, Republic of
|
15 participants
n=5 Participants
|
19 participants
n=7 Participants
|
20 participants
n=5 Participants
|
19 participants
n=4 Participants
|
13 participants
n=21 Participants
|
15 participants
n=10 Participants
|
101 participants
n=115 Participants
|
|
Region of Enrollment
Taiwan
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
15 participants
n=5 Participants
|
16 participants
n=4 Participants
|
10 participants
n=21 Participants
|
11 participants
n=10 Participants
|
78 participants
n=115 Participants
|
|
Region of Enrollment
Thailand
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
4 participants
n=21 Participants
|
6 participants
n=10 Participants
|
29 participants
n=115 Participants
|
|
Body Mass Index (BMI)
BMI
|
25.86 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 2.907 • n=5 Participants
|
25.75 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 2.990 • n=7 Participants
|
26.06 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 2.637 • n=5 Participants
|
26.19 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 2.999 • n=4 Participants
|
22.02 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 4.106 • n=21 Participants
|
22.10 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 3.166 • n=10 Participants
|
24.74 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 3.510 • n=115 Participants
|
|
Qualifying Diagnosis
Unstable angina (UA)
|
32 participants
n=5 Participants
|
42 participants
n=7 Participants
|
38 participants
n=5 Participants
|
41 participants
n=4 Participants
|
26 participants
n=21 Participants
|
30 participants
n=10 Participants
|
209 participants
n=115 Participants
|
|
Qualifying Diagnosis
Non-ST segment elevation myocardial infarction
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
21 participants
n=5 Participants
|
17 participants
n=4 Participants
|
10 participants
n=21 Participants
|
10 participants
n=10 Participants
|
87 participants
n=115 Participants
|
|
Qualifying Diagnosis
ST segment elevation myocardial infarction
|
72 participants
n=5 Participants
|
64 participants
n=7 Participants
|
74 participants
n=5 Participants
|
77 participants
n=4 Participants
|
55 participants
n=21 Participants
|
53 participants
n=10 Participants
|
395 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: At 4 hours following LD administrationPopulation: Per Protocol Set (PPS) LD population PPS: all randomized participants with ≥1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations LD population: never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization and received percutaneous coronary intervention (PCI) for index event
ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition. Observed PRU values are presented with statistical comparisons of difference in least squares mean (LS mean) PRU values between prasugrel and clopidogrel. Efficacy analyses are analyzed and presented separately for the LD and maintenance dose (MD) phase.
Outcome measures
| Measure |
Prasugrel 60-mg LD Primary
n=35 Participants
Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
|
Prasugrel 30-mg LD Primary
n=79 Participants
Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
|
Clopidogrel 300-mg LD Primary
n=44 Participants
Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
|
Prasugrel 30-mg LD Low Weight/Elderly
Population includes participants in low weight/elderly cohort who were randomly assigned to receive a prasugrel 30-mg LD.
|
Clopidogrel 300-mg LD Low Weight/Elderly
Population includes participants in low weight/elderly cohort who randomly assigned to receive a clopidogrel 300-mg LD.
|
Clopidogrel 300/75 Low Weight/Elderly
Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)
|
|---|---|---|---|---|---|---|
|
Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation (P2Y12 Reaction Units; PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 4 Hours Post-Loading Dose (LD) in Primary Cohort (≥60 kg and <75 Years)
|
88.5 PRU
Standard Deviation 104.86
|
124.2 PRU
Standard Deviation 117.28
|
261.8 PRU
Standard Deviation 83.87
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At 30 days during MD therapyPopulation: Per protocol set (PPS) MD population PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations MD population: received percutaneous coronary intervention (PCI) for index event
Efficacy analyses are analyzed and presented separately for the loading dose (LD) and MD phase. This primary outcome analysis compares PRU for the 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with the clopidogrel 75-mg MD at 30 days post-MD in the primary cohort (participants who weighed ≥60 kg and were \<75 years). ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition. Observed PRU values are presented with statistical comparisons of LS mean difference between prasugrel and clopidogrel.
Outcome measures
| Measure |
Prasugrel 60-mg LD Primary
n=69 Participants
Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
|
Prasugrel 30-mg LD Primary
n=63 Participants
Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
|
Clopidogrel 300-mg LD Primary
n=69 Participants
Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
|
Prasugrel 30-mg LD Low Weight/Elderly
n=78 Participants
Population includes participants in low weight/elderly cohort who were randomly assigned to receive a prasugrel 30-mg LD.
|
Clopidogrel 300-mg LD Low Weight/Elderly
Population includes participants in low weight/elderly cohort who randomly assigned to receive a clopidogrel 300-mg LD.
|
Clopidogrel 300/75 Low Weight/Elderly
Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)
|
|---|---|---|---|---|---|---|
|
Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Days During Maintenance Dose (MD) Administration in Primary Cohort
|
71.6 PRU
Standard Deviation 65.56
|
99.3 PRU
Standard Deviation 72.63
|
150.8 PRU
Standard Deviation 77.76
|
206.5 PRU
Standard Deviation 72.68
|
—
|
—
|
SECONDARY outcome
Timeframe: At 30 minutes, 2 hours, and 4 hours following LD administrationPopulation: Per Protocol Set (PPS) LD population PPS: all randomized participants with at least 1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations LD population: never used glycoprotein (GP)IIb/IIIa inhibitor during index hospitalization, received percutaneous coronary intervention (PCI) for index event
Efficacy analyses analyzed and presented separately for LD and maintenance dose (MD) phase. Analysis compares PRU for prasugrel LDs (30 mg and 60 mg) with clopidogrel 300-mg LD at 30 minutes post-LD. Data for Primary Cohort at 4 hours post-LD, already presented in first Primary Outcome Measure, are also presented here. ADP-induced PRU serves as biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition. Observed PRU values presented with statistical comparisons of least-squares mean (LS mean) difference between prasugrel and clopidogrel.
Outcome measures
| Measure |
Prasugrel 60-mg LD Primary
n=43 Participants
Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
|
Prasugrel 30-mg LD Primary
n=90 Participants
Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
|
Clopidogrel 300-mg LD Primary
n=54 Participants
Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
|
Prasugrel 30-mg LD Low Weight/Elderly
n=33 Participants
Population includes participants in low weight/elderly cohort who were randomly assigned to receive a prasugrel 30-mg LD.
|
Clopidogrel 300-mg LD Low Weight/Elderly
n=34 Participants
Population includes participants in low weight/elderly cohort who randomly assigned to receive a clopidogrel 300-mg LD.
|
Clopidogrel 300/75 Low Weight/Elderly
Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)
|
|---|---|---|---|---|---|---|
|
Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.
30 min (n=40, n=79, n=48, n=33, n=34)
|
250.5 PRU
Standard Deviation 109.02
|
280.4 PRU
Standard Deviation 112.58
|
312.1 PRU
Standard Deviation 72.41
|
311.2 PRU
Standard Deviation 96.46
|
379.5 PRU
Standard Deviation 53.29
|
—
|
|
Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.
2 hours (n=37, n=80, n=49, n=33, n=33)
|
116.9 PRU
Standard Deviation 116.48
|
178.8 PRU
Standard Deviation 128.37
|
289.5 PRU
Standard Deviation 71.77
|
171.8 PRU
Standard Deviation 123.37
|
339.0 PRU
Standard Deviation 74.03
|
—
|
|
Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.
4 hours (n=35, n=79, n=44, n=33, n=33)
|
88.5 PRU
Standard Deviation 104.86
|
124.2 PRU
Standard Deviation 117.28
|
261.8 PRU
Standard Deviation 83.87
|
127.3 PRU
Standard Deviation 106.38
|
337.8 PRU
Standard Deviation 85.15
|
—
|
SECONDARY outcome
Timeframe: At 30 Days and 90 days during MD therapyPopulation: Per Protocol Set (PPS) MD population PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations in MD population: received percutaneous coronary intervention (PCI) for index event
Efficacy analyses analyzed and presented separately for loading dose (LD) and MD phase. Analysis compares PRU for 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with clopidogrel 75-mg MD at 30 days post-MD. Data for Primary Cohort at 30 days post-LD, already presented in second Primary Outcome Measure, are also presented here. ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition. Observed PRU values are presented with statistical comparisons of least squares (LS) mean difference between prasugrel and clopidogrel.
Outcome measures
| Measure |
Prasugrel 60-mg LD Primary
n=74 Participants
Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
|
Prasugrel 30-mg LD Primary
n=69 Participants
Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
|
Clopidogrel 300-mg LD Primary
n=75 Participants
Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
|
Prasugrel 30-mg LD Low Weight/Elderly
n=89 Participants
Population includes participants in low weight/elderly cohort who were randomly assigned to receive a prasugrel 30-mg LD.
|
Clopidogrel 300-mg LD Low Weight/Elderly
n=55 Participants
Population includes participants in low weight/elderly cohort who randomly assigned to receive a clopidogrel 300-mg LD.
|
Clopidogrel 300/75 Low Weight/Elderly
n=54 Participants
Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)
|
|---|---|---|---|---|---|---|
|
Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort
30 days (n=69, n=63, n=69, n=78, n=47, n=48)
|
71.6 PRU
Standard Deviation 65.56
|
99.3 PRU
Standard Deviation 72.63
|
150.8 PRU
Standard Deviation 77.76
|
206.5 PRU
Standard Deviation 72.68
|
134.2 PRU
Standard Deviation 80.29
|
237.5 PRU
Standard Deviation 108.32
|
|
Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort
90 Days (n=60, n=57, n=64, n=72, n=43, n=42)
|
64.8 PRU
Standard Deviation 55.99
|
89.4 PRU
Standard Deviation 91.75
|
138.5 PRU
Standard Deviation 80.42
|
188.3 PRU
Standard Deviation 81.24
|
128.5 PRU
Standard Deviation 70.42
|
219.6 PRU
Standard Deviation 95.06
|
SECONDARY outcome
Timeframe: 30 minutes, 2 hours, and 4 hours following LD administrationPopulation: Per Protocol Set (PPS) LD population PPS: all randomized participants with at least 1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations LD population: never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization, received percutaneous coronary intervention (PCI) for index event
A higher percentage (percent inhibition least squares mean \[LS mean\]) represents greater platelet inhibition.
Outcome measures
| Measure |
Prasugrel 60-mg LD Primary
n=43 Participants
Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
|
Prasugrel 30-mg LD Primary
n=90 Participants
Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
|
Clopidogrel 300-mg LD Primary
n=54 Participants
Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
|
Prasugrel 30-mg LD Low Weight/Elderly
n=33 Participants
Population includes participants in low weight/elderly cohort who were randomly assigned to receive a prasugrel 30-mg LD.
|
Clopidogrel 300-mg LD Low Weight/Elderly
n=34 Participants
Population includes participants in low weight/elderly cohort who randomly assigned to receive a clopidogrel 300-mg LD.
|
Clopidogrel 300/75 Low Weight/Elderly
Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)
|
|---|---|---|---|---|---|---|
|
Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort
30 minutes (n=40, n=79, n=47, n=32, n=31)
|
10 Percent inhibition
|
4 Percent inhibition
|
-5 Percent inhibition
|
11 Percent inhibition
|
0 Percent inhibition
|
—
|
|
Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort
2 hours (n=37, n=80, n=48, n=33, n=33)
|
49 Percent inhibition
|
34 Percent inhibition
|
-2 Percent inhibition
|
51 Percent inhibition
|
2 Percent inhibition
|
—
|
|
Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort
4 hours (n=34, n=79, n=43, n=33, n=33)
|
65 Percent inhibition
|
51 Percent inhibition
|
4 Percent inhibition
|
63 Percent inhibition
|
7 Percent inhibition
|
—
|
SECONDARY outcome
Timeframe: 30 days and at 90 days during MD therapyPopulation: Per Protocol Set (PPS) MD population PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations MD population: received percutaneous coronary intervention (PCI) for index event
A higher percentage (percent inhibition least squares mean \[LS mean\]) represents greater platelet inhibition.
Outcome measures
| Measure |
Prasugrel 60-mg LD Primary
n=74 Participants
Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
|
Prasugrel 30-mg LD Primary
n=69 Participants
Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
|
Clopidogrel 300-mg LD Primary
n=75 Participants
Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
|
Prasugrel 30-mg LD Low Weight/Elderly
n=89 Participants
Population includes participants in low weight/elderly cohort who were randomly assigned to receive a prasugrel 30-mg LD.
|
Clopidogrel 300-mg LD Low Weight/Elderly
n=55 Participants
Population includes participants in low weight/elderly cohort who randomly assigned to receive a clopidogrel 300-mg LD.
|
Clopidogrel 300/75 Low Weight/Elderly
n=54 Participants
Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)
|
|---|---|---|---|---|---|---|
|
Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort
30 Days (n=69, n=63, n=68, n=78, n=47, n=48)
|
67 Percent inhibition
|
60 Percent inhibition
|
45 Percent inhibition
|
29 Percent inhibition
|
68 Percent inhibition
|
32 Percent inhibition
|
|
Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort
90 Days (n=60, n=57, n=64, n=72, n=43, n=42)
|
73 Percent inhibition
|
66 Percent inhibition
|
48 Percent inhibition
|
38 Percent inhibition
|
69 Percent inhibition
|
38 Percent inhibition
|
SECONDARY outcome
Timeframe: Randomization through end of study (90 days)Population: Full analysis set (FAS) FAS: all randomized subjects who received at least 1 dose of study drug
Nonfatal MI: American College of Cardiology (ACC) definition Nonfatal stroke: rapid onset of new, persistent neurologic deficit lasting \>24 hours; classified as either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available. Stent thrombosis: defined as definite, probable, or possible, based on Academic Research Consortium definitions. UTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure
Outcome measures
| Measure |
Prasugrel 60-mg LD Primary
n=117 Participants
Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
|
Prasugrel 30-mg LD Primary
n=122 Participants
Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
|
Clopidogrel 300-mg LD Primary
n=133 Participants
Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
|
Prasugrel 30-mg LD Low Weight/Elderly
n=136 Participants
Population includes participants in low weight/elderly cohort who were randomly assigned to receive a prasugrel 30-mg LD.
|
Clopidogrel 300-mg LD Low Weight/Elderly
n=91 Participants
Population includes participants in low weight/elderly cohort who randomly assigned to receive a clopidogrel 300-mg LD.
|
Clopidogrel 300/75 Low Weight/Elderly
n=93 Participants
Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)
|
|---|---|---|---|---|---|---|
|
Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort
Fatal MI
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort
Nonfatal MI
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort
Fatal Stroke
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort
Nonfatal Stroke
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort
Definite Stent Thrombosis
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort
UTVR
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days and 90 daysPopulation: As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.
Risk was defined as the number of participants with events of CV death, nonfatal MI, or nonfatal stroke. CV death: death caused by CV event or not clearly attributable to non-CV causes. Nonfatal MI: per adapted American College of Cardiology definition. Nonfatal stroke: rapid onset of new, persistent neurologic deficit lasting more than 24 hours; either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available. As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days and 90 daysPopulation: As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.
Risk was defined as the number of participants with events of CV death, nonfatal MI, or UTVR. UTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure. As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days and 90 daysPopulation: As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.
Risk was defined as the number of events of CV death, nonfatal MI, nonfatal stroke or recurrent myocardial ischemia requiring hospitalization. Recurrent myocardial ischemia requiring hospitalization: rehospitalization for symptoms of myocardial ischemia at rest with either new ST-segment deviation ≥1 mm, or performance of a coronary revascularization procedure percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) during the same hospital stay. As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days and 90 daysPopulation: As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.
Risk was defined as the number of participants with events of CV death, nonfatal MI, nonfatal stroke, UTVR, or recurrent myocardial ischemia requiring hospitalization.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days and 90 daysPopulation: As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.
Risk was defined as the number of participants with events of definite or probable stent thrombosis. As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 daysPopulation: As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.
Risk was defined as the number of participants with events of definite, probable, or possible stent thrombosis. As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization through end of study (90 days)Population: Full Analysis Set (FAS): all randomized subjects who received at least 1 dose of study drug
Risk was defined as the number of participants with events of all-cause death.
Outcome measures
| Measure |
Prasugrel 60-mg LD Primary
n=117 Participants
Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
|
Prasugrel 30-mg LD Primary
n=122 Participants
Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
|
Clopidogrel 300-mg LD Primary
n=133 Participants
Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
|
Prasugrel 30-mg LD Low Weight/Elderly
n=135 Participants
Population includes participants in low weight/elderly cohort who were randomly assigned to receive a prasugrel 30-mg LD.
|
Clopidogrel 300-mg LD Low Weight/Elderly
n=91 Participants
Population includes participants in low weight/elderly cohort who randomly assigned to receive a clopidogrel 300-mg LD.
|
Clopidogrel 300/75 Low Weight/Elderly
n=93 Participants
Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)
|
|---|---|---|---|---|---|---|
|
Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort
|
5 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Randomization through end of study (90 days)Population: Safety analysis set (SAS): all randomized participants with at least 1 dose of study drug Two (2) participants had no event date; time from start of therapy to event was missing and thus they were not included in this table.
Bleeding events were classified and analyzed in accordance with the TIMI criteria definitions. Major bleeding: any intracranial hemorrhage (ICR) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 grams/deciliter (gm/dL) from baseline. Minor bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 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 60-mg LD Primary
n=117 Participants
Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
|
Prasugrel 30-mg LD Primary
n=122 Participants
Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
|
Clopidogrel 300-mg LD Primary
n=133 Participants
Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
|
Prasugrel 30-mg LD Low Weight/Elderly
n=136 Participants
Population includes participants in low weight/elderly cohort who were randomly assigned to receive a prasugrel 30-mg LD.
|
Clopidogrel 300-mg LD Low Weight/Elderly
n=91 Participants
Population includes participants in low weight/elderly cohort who randomly assigned to receive a clopidogrel 300-mg LD.
|
Clopidogrel 300/75 Low Weight/Elderly
n=93 Participants
Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)
|
|---|---|---|---|---|---|---|
|
Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding
≤3 Days of LD Major
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
|
Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding
≤3 Days of LD Life Threatening
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding
≤3 Days of LD Minor
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding
≤3 Days of LD Minimal
|
5 participants
|
4 participants
|
6 participants
|
4 participants
|
1 participants
|
1 participants
|
|
Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding
>3 Days of LD Major
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding
>3 Days of LD Life Threatening
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding
>3 Days of LD Minor
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding
>3 Days of LD Minimal
|
1 participants
|
2 participants
|
7 participants
|
3 participants
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Randomization through end of study (90 days)Population: Safety Analysis Set (SAS): all randomized participants with at least 1 dose of study drug In 10 participants, study drug discontinued due to planned CABG. 1 participant had CABG reported on revascularization case report form (CRF); no reports of CABG bleeding event
Outcome measures
| Measure |
Prasugrel 60-mg LD Primary
n=117 Participants
Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
|
Prasugrel 30-mg LD Primary
n=122 Participants
Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
|
Clopidogrel 300-mg LD Primary
n=133 Participants
Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
|
Prasugrel 30-mg LD Low Weight/Elderly
n=136 Participants
Population includes participants in low weight/elderly cohort who were randomly assigned to receive a prasugrel 30-mg LD.
|
Clopidogrel 300-mg LD Low Weight/Elderly
n=91 Participants
Population includes participants in low weight/elderly cohort who randomly assigned to receive a clopidogrel 300-mg LD.
|
Clopidogrel 300/75 Low Weight/Elderly
n=93 Participants
Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)
|
|---|---|---|---|---|---|---|
|
Incidence of CABG-related TIMI Major or Minor Bleeding.
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Initial hospitalization, 30 days, 90 daysPopulation: As a consequence of the overall low number of reported clinical events, inpatient healthcare resource utilization data were not analyzed; thus zero participants were analyzed.
Healthcare resource utilization data were modeled from historical analyses to determine initial hospitalization costs, total 30-day medical care costs, and total 90-day medical care costs.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 4 hours post-loading dose (LD), 30 days and 90 days during maintenance dose (MD) phasePopulation: Pharmacodynamic analysis set is subset of FAS (≥1 genetics sample, ≥1 dose of study drug, ≥1 post-baseline PRU measurement, no significant protocol violations). Genetics subset LD population never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization. Participants classified as EM or RM. Invalid measurements of PRU were excluded.
The primary hypothesis for the genetics substudy was that CYP2C19 genetic variation has a significant effect on pharmacodynamic (PD) response to clopidogrel but not on PD response to prasugrel per change in PRU as measured by the Accumetrics VerifyNow P2Y12 device. Participants were classified by CYP2C19 genotype into predicted metabolic phenotypes according to literature-based functional predictions. These classifications were clustered into 2 groups: extensive metabolizer (EM) and reduced metabolizer (RM). A higher value for change in PRU indicates a greater level of platelet inhibition.
Outcome measures
| Measure |
Prasugrel 60-mg LD Primary
n=83 Participants
Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
|
Prasugrel 30-mg LD Primary
n=76 Participants
Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
|
Clopidogrel 300-mg LD Primary
n=155 Participants
Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
|
Prasugrel 30-mg LD Low Weight/Elderly
n=162 Participants
Population includes participants in low weight/elderly cohort who were randomly assigned to receive a prasugrel 30-mg LD.
|
Clopidogrel 300-mg LD Low Weight/Elderly
Population includes participants in low weight/elderly cohort who randomly assigned to receive a clopidogrel 300-mg LD.
|
Clopidogrel 300/75 Low Weight/Elderly
Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight \<60 kg or age ≥75 years)
|
|---|---|---|---|---|---|---|
|
Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary
90 days, EM (n=12, n=18, n=30, n=28)
|
-203.8 Change in PRU
Standard Deviation 102.89
|
-210.0 Change in PRU
Standard Deviation 110.68
|
-187.2 Change in PRU
Standard Deviation 92.70
|
-141.0 Change in PRU
Standard Deviation 75.58
|
—
|
—
|
|
Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary
4 hours, EM (n=15, n=18, n=27, n=31)
|
-162.9 Change in PRU
Standard Deviation 154.30 • Interval -397.0 to 144.0
|
-198.8 Change in PRU
Standard Deviation 90.71 • Interval -230.0 to 215.0
|
-217.2 Change in PRU
Standard Deviation 83.52
|
-9.7 Change in PRU
Standard Deviation 72.30
|
—
|
—
|
|
Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary
4 hours, RM (n=18, n=21, n=45, n=45)
|
-245.9 Change in PRU
Standard Deviation 102.77
|
-183.3 Change in PRU
Standard Deviation 123.29
|
-181.9 Change in PRU
Standard Deviation 129.47
|
-22.2 Change in PRU
Standard Deviation 72.84
|
—
|
—
|
|
Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary
30 days, EM (n=17, n=21, n=31, n=30)
|
-193.9 Change in PRU
Standard Deviation 98.17
|
-196.5 Change in PRU
Standard Deviation 88.90
|
-187.5 Change in PRU
Standard Deviation 94.79
|
-110.6 Change in PRU
Standard Deviation 83.49
|
—
|
—
|
|
Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary
30 days, RM (n=19, n=21. n=43, n=47)
|
-250.3 Change in PRU
Standard Deviation 90.17
|
-208.5 Change in PRU
Standard Deviation 74.23
|
-152.8 Change in PRU
Standard Deviation 88.97
|
-81.7 Change in PRU
Standard Deviation 70.56
|
—
|
—
|
|
Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary
90 days, RM (n=17, n=21, n=36, n=41)
|
-267.5 Change in PRU
Standard Deviation 70.86
|
-225.7 Change in PRU
Standard Deviation 76.52
|
-164.1 Change in PRU
Standard Deviation 75.90
|
-100.7 Change in PRU
Standard Deviation 92.24
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days and 90 daysPopulation: As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.
Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)
Outcome measures
Outcome data not reported
Adverse Events
Prasugrel 60/10 Primary
Serious events: 8 serious events
Other events: 54 other events
Deaths: 0 deaths
Prasugrel 30/7.5 Primary
Serious events: 7 serious events
Other events: 38 other events
Deaths: 0 deaths
Prasugrel 30/5 Primary
Serious events: 4 serious events
Other events: 45 other events
Deaths: 0 deaths
Clopidogrel 300/75 Primary
Serious events: 6 serious events
Other events: 49 other events
Deaths: 0 deaths
Prasugrel 30/5 Low Weight/Elderly
Serious events: 9 serious events
Other events: 28 other events
Deaths: 0 deaths
Clopidogrel 300/75 Low Weight/Elderly
Serious events: 10 serious events
Other events: 34 other events
Deaths: 0 deaths
Clopidogrel 300/75 No Weight
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prasugrel 60/10 Primary
n=117 participants at risk
Primary = participant weight ≥60 kg and age \<75 years. Loading dose 60 mg followed by maintenance dose 10 mg/day.
|
Prasugrel 30/7.5 Primary
n=122 participants at risk
Primary = participant weight ≥60 kg and age \<75 years. Loading dose 30mg followed by maintenance dose 7.5 mg/day
|
Prasugrel 30/5 Primary
n=133 participants at risk
Primary = participant weight ≥60 kg and age \<75 years. Loading dose 30 mg followed by maintenance dose 5 mg/day.
|
Clopidogrel 300/75 Primary
n=135 participants at risk
Primary = participant weight ≥60 kg and age \<75 years. Loading dose 300 mg followed by maintenance dose 75 mg/day
|
Prasugrel 30/5 Low Weight/Elderly
n=91 participants at risk
Low Weight/Elderly = participant weight \<60 kg or age ≥75 years. Loading dose 30 mg followed by maintenance dose 5 mg/day.
|
Clopidogrel 300/75 Low Weight/Elderly
n=93 participants at risk
Low Weight/Elderly = participant weight \<60 kg or age ≥75 years. Loading dose 300 mg followed by maintenance dose 75 mg/day
|
Clopidogrel 300/75 No Weight
n=1 participants at risk
Participant didn't have weight recorded. Loading dose 300 mg followed by maintenance dose 75 mg/day
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute left ventricular failure
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/117
|
0.00%
0/122
|
0.75%
1/133 • Number of events 1
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Cardiac disorders
Atrioventricular block complete
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.74%
1/135 • Number of events 1
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
Cardiac failure acute
|
0.85%
1/117 • Number of events 1
|
0.82%
1/122 • Number of events 2
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/117
|
0.82%
1/122 • Number of events 1
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Cardiac disorders
Palpitations
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/117
|
0.82%
1/122 • Number of events 1
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Gastrointestinal disorders
Gastritis
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
0.75%
1/133 • Number of events 1
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.6%
3/117 • Number of events 3
|
0.82%
1/122 • Number of events 1
|
0.00%
0/133
|
0.00%
0/135
|
2.2%
2/91 • Number of events 2
|
2.2%
2/93 • Number of events 2
|
0.00%
0/1
|
|
General disorders
Chest discomfort
|
0.00%
0/117
|
0.00%
0/122
|
0.75%
1/133 • Number of events 1
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
General disorders
Chest pain
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
General disorders
Pyrexia
|
0.00%
0/117
|
0.82%
1/122 • Number of events 1
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/117
|
0.82%
1/122 • Number of events 1
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.74%
1/135 • Number of events 1
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Infections and infestations
Lung infection
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Pneumonia
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Cardiac enzymes increased
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
2.2%
2/93 • Number of events 2
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/117
|
0.82%
1/122 • Number of events 1
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.74%
1/135 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue carcinoma stage I
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.74%
1/135 • Number of events 1
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.74%
1/135 • Number of events 1
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/117
|
0.00%
0/122
|
0.75%
1/133 • Number of events 1
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/117
|
0.00%
0/122
|
0.75%
1/133 • Number of events 1
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 2
|
0.00%
0/93
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
2.2%
2/93 • Number of events 2
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.74%
1/135 • Number of events 1
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.74%
1/135 • Number of events 1
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
Other adverse events
| Measure |
Prasugrel 60/10 Primary
n=117 participants at risk
Primary = participant weight ≥60 kg and age \<75 years. Loading dose 60 mg followed by maintenance dose 10 mg/day.
|
Prasugrel 30/7.5 Primary
n=122 participants at risk
Primary = participant weight ≥60 kg and age \<75 years. Loading dose 30mg followed by maintenance dose 7.5 mg/day
|
Prasugrel 30/5 Primary
n=133 participants at risk
Primary = participant weight ≥60 kg and age \<75 years. Loading dose 30 mg followed by maintenance dose 5 mg/day.
|
Clopidogrel 300/75 Primary
n=135 participants at risk
Primary = participant weight ≥60 kg and age \<75 years. Loading dose 300 mg followed by maintenance dose 75 mg/day
|
Prasugrel 30/5 Low Weight/Elderly
n=91 participants at risk
Low Weight/Elderly = participant weight \<60 kg or age ≥75 years. Loading dose 30 mg followed by maintenance dose 5 mg/day.
|
Clopidogrel 300/75 Low Weight/Elderly
n=93 participants at risk
Low Weight/Elderly = participant weight \<60 kg or age ≥75 years. Loading dose 300 mg followed by maintenance dose 75 mg/day
|
Clopidogrel 300/75 No Weight
n=1 participants at risk
Participant didn't have weight recorded. Loading dose 300 mg followed by maintenance dose 75 mg/day
|
|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.74%
1/135 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Anaemia
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
0.00%
0/133
|
0.74%
1/135 • Number of events 1
|
0.00%
0/91
|
3.2%
3/93 • Number of events 3
|
0.00%
0/1
|
|
Cardiac disorders
Acute myocardial infarction
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
0.75%
1/133 • Number of events 1
|
0.74%
1/135 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/117
|
0.82%
1/122 • Number of events 1
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
1.5%
2/135 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
1.5%
2/135 • Number of events 2
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/117
|
0.00%
0/122
|
0.75%
1/133 • Number of events 1
|
0.00%
0/135
|
2.2%
2/91 • Number of events 2
|
0.00%
0/93
|
0.00%
0/1
|
|
Cardiac disorders
Cardiogenic shock
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
0.75%
1/133 • Number of events 1
|
1.5%
2/135 • Number of events 2
|
2.2%
2/91 • Number of events 2
|
0.00%
0/93
|
0.00%
0/1
|
|
Cardiac disorders
Coronary artery dissection
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
100.0%
1/1 • Number of events 1
|
|
Cardiac disorders
Myocardial rupture
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
Palpitations
|
0.00%
0/117
|
0.82%
1/122 • Number of events 1
|
0.75%
1/133 • Number of events 2
|
1.5%
2/135 • Number of events 2
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/117
|
2.5%
3/122 • Number of events 3
|
0.00%
0/133
|
1.5%
2/135 • Number of events 2
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/117
|
0.00%
0/122
|
1.5%
2/133 • Number of events 2
|
0.74%
1/135 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/117
|
0.82%
1/122 • Number of events 1
|
0.75%
1/133 • Number of events 1
|
0.74%
1/135 • Number of events 1
|
2.2%
2/91 • Number of events 2
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/117
|
0.82%
1/122 • Number of events 2
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/117
|
0.82%
1/122 • Number of events 1
|
1.5%
2/133 • Number of events 2
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/117
|
1.6%
2/122 • Number of events 2
|
2.3%
3/133 • Number of events 3
|
0.74%
1/135 • Number of events 1
|
2.2%
2/91 • Number of events 2
|
2.2%
2/93 • Number of events 2
|
0.00%
0/1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.85%
1/117 • Number of events 1
|
1.6%
2/122 • Number of events 2
|
0.75%
1/133 • Number of events 1
|
0.00%
0/135
|
3.3%
3/91 • Number of events 3
|
2.2%
2/93 • Number of events 2
|
0.00%
0/1
|
|
Gastrointestinal disorders
Dyspepsia
|
2.6%
3/117 • Number of events 3
|
0.00%
0/122
|
0.75%
1/133 • Number of events 1
|
0.74%
1/135 • Number of events 1
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.85%
1/117 • Number of events 1
|
1.6%
2/122 • Number of events 2
|
3.0%
4/133 • Number of events 4
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Gastrointestinal disorders
Nausea
|
2.6%
3/117 • Number of events 3
|
0.00%
0/122
|
0.00%
0/133
|
0.74%
1/135 • Number of events 1
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
2/117 • Number of events 2
|
0.00%
0/122
|
0.75%
1/133 • Number of events 1
|
0.74%
1/135 • Number of events 1
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
General disorders
Chest discomfort
|
3.4%
4/117 • Number of events 6
|
0.00%
0/122
|
0.00%
0/133
|
3.0%
4/135 • Number of events 4
|
0.00%
0/91
|
4.3%
4/93 • Number of events 4
|
0.00%
0/1
|
|
General disorders
Chest pain
|
0.85%
1/117 • Number of events 1
|
1.6%
2/122 • Number of events 3
|
0.75%
1/133 • Number of events 1
|
1.5%
2/135 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
General disorders
Facial pain
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
General disorders
Oedema peripheral
|
0.00%
0/117
|
0.82%
1/122 • Number of events 1
|
0.00%
0/133
|
1.5%
2/135 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
General disorders
Pain
|
1.7%
2/117 • Number of events 2
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
General disorders
Pyrexia
|
3.4%
4/117 • Number of events 5
|
1.6%
2/122 • Number of events 2
|
2.3%
3/133 • Number of events 3
|
0.74%
1/135 • Number of events 1
|
3.3%
3/91 • Number of events 3
|
3.2%
3/93 • Number of events 3
|
0.00%
0/1
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.7%
2/117 • Number of events 2
|
0.82%
1/122 • Number of events 1
|
0.75%
1/133 • Number of events 1
|
0.74%
1/135 • Number of events 1
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Lung infection
|
0.00%
0/117
|
1.6%
2/122 • Number of events 2
|
1.5%
2/133 • Number of events 3
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
1.5%
2/133 • Number of events 2
|
0.00%
0/135
|
2.2%
2/91 • Number of events 2
|
0.00%
0/93
|
0.00%
0/1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/117
|
0.00%
0/122
|
0.75%
1/133 • Number of events 1
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Investigations
Blood creatinine increased
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
2.2%
2/93 • Number of events 2
|
0.00%
0/1
|
|
Investigations
Blood glucose increased
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
0.75%
1/133 • Number of events 1
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Investigations
High density lipoprotein decreased
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
1.5%
2/133 • Number of events 2
|
1.5%
2/135 • Number of events 2
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Transaminases increased
|
0.85%
1/117 • Number of events 1
|
0.82%
1/122 • Number of events 2
|
1.5%
2/133 • Number of events 2
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.6%
3/117 • Number of events 3
|
0.82%
1/122 • Number of events 1
|
3.0%
4/133 • Number of events 4
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.85%
1/117 • Number of events 1
|
0.82%
1/122 • Number of events 1
|
0.75%
1/133 • Number of events 1
|
0.74%
1/135 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.85%
1/117 • Number of events 1
|
0.82%
1/122 • Number of events 1
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.6%
3/117 • Number of events 3
|
0.82%
1/122 • Number of events 2
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.85%
1/117 • Number of events 1
|
1.6%
2/122 • Number of events 2
|
0.75%
1/133 • Number of events 1
|
1.5%
2/135 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
2.2%
2/93 • Number of events 2
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.7%
2/117 • Number of events 2
|
0.82%
1/122 • Number of events 1
|
0.00%
0/133
|
1.5%
2/135 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.6%
3/117 • Number of events 3
|
0.82%
1/122 • Number of events 1
|
1.5%
2/133 • Number of events 2
|
2.2%
3/135 • Number of events 3
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hypocholesterolaemia
|
0.00%
0/117
|
0.00%
0/122
|
0.75%
1/133 • Number of events 1
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.85%
1/117 • Number of events 1
|
0.82%
1/122 • Number of events 1
|
1.5%
2/133 • Number of events 2
|
0.00%
0/135
|
0.00%
0/91
|
3.2%
3/93 • Number of events 3
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
1.5%
2/133 • Number of events 2
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
2/117 • Number of events 2
|
1.6%
2/122 • Number of events 2
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/117
|
0.82%
1/122 • Number of events 1
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to stomach
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Nervous system disorders
Dizziness
|
1.7%
2/117 • Number of events 2
|
0.00%
0/122
|
2.3%
3/133 • Number of events 3
|
2.2%
3/135 • Number of events 4
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Nervous system disorders
Headache
|
2.6%
3/117 • Number of events 3
|
0.00%
0/122
|
2.3%
3/133 • Number of events 3
|
1.5%
2/135 • Number of events 3
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Nervous system disorders
Lethargy
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 2
|
0.00%
0/1
|
|
Nervous system disorders
Tremor
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Psychiatric disorders
Insomnia
|
1.7%
2/117 • Number of events 2
|
1.6%
2/122 • Number of events 2
|
0.75%
1/133 • Number of events 1
|
0.74%
1/135 • Number of events 1
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.74%
1/135 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/117
|
0.82%
1/122 • Number of events 1
|
0.00%
0/133
|
1.5%
2/135 • Number of events 2
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Bradypnoea
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/117
|
0.82%
1/122 • Number of events 1
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
2/117 • Number of events 2
|
1.6%
2/122 • Number of events 3
|
6.0%
8/133 • Number of events 8
|
6.7%
9/135 • Number of events 9
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
4/117 • Number of events 6
|
2.5%
3/122 • Number of events 3
|
0.00%
0/133
|
2.2%
3/135 • Number of events 3
|
1.1%
1/91 • Number of events 1
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
2/117 • Number of events 2
|
0.00%
0/122
|
0.75%
1/133 • Number of events 1
|
0.74%
1/135 • Number of events 1
|
2.2%
2/91 • Number of events 2
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
1.5%
2/135 • Number of events 2
|
0.00%
0/91
|
0.00%
0/93
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.6%
3/117 • Number of events 3
|
1.6%
2/122 • Number of events 2
|
2.3%
3/133 • Number of events 3
|
1.5%
2/135 • Number of events 2
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/117
|
0.82%
1/122 • Number of events 1
|
1.5%
2/133 • Number of events 2
|
0.74%
1/135 • Number of events 1
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.85%
1/117 • Number of events 1
|
0.00%
0/122
|
0.00%
0/133
|
0.74%
1/135 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
3.2%
3/93 • Number of events 3
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Surgical and medical procedures
Enema administration
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
|
Vascular disorders
Haematoma
|
0.00%
0/117
|
1.6%
2/122 • Number of events 2
|
0.00%
0/133
|
1.5%
2/135 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
2.2%
2/93 • Number of events 3
|
0.00%
0/1
|
|
Vascular disorders
Hypertension
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
1.5%
2/135 • Number of events 2
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Vascular disorders
Hypotension
|
0.85%
1/117 • Number of events 1
|
1.6%
2/122 • Number of events 2
|
0.00%
0/133
|
0.00%
0/135
|
0.00%
0/91
|
1.1%
1/93 • Number of events 1
|
0.00%
0/1
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/117
|
0.00%
0/122
|
0.00%
0/133
|
0.00%
0/135
|
1.1%
1/91 • Number of events 1
|
0.00%
0/93
|
0.00%
0/1
|
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