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Comparison of Prasugrel and Clopidogrel in Very Elderly and Non-Elderly Patients With Stable Coronary Artery Disease (GENERATIONS)

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ClinicalTrials.gov Identifier: NCT01107912
Recruitment Status : Completed
First Posted : April 21, 2010
Results First Posted : October 26, 2012
Last Update Posted : October 26, 2012
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Interventions Drug: prasugrel
Drug: clopidogrel
Enrollment 155
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 5 mg Prasugrel (Elderly) 10 mg Prasugrel (Elderly) 75 mg Clopidogrel (Elderly) 5 mg Prasugrel (Non-Elderly) 10 mg Prasugrel (Non-Elderly) 75 mg Clopidogrel (Non-Elderly)
Hide Arm/Group Description Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2. Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3. Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3. Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3. Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2. Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
Period Title: Period 1
Started 73 0 0 0 82 0
Received at Least 1 Dose of Study Drug 73 0 0 0 82 0
Completed 72 0 0 0 79 0
Not Completed 1 0 0 0 3 0
Reason Not Completed
Adverse Event             0             0             0             0             2             0
Physician Decision             0             0             0             0             1             0
Withdrawal by Subject             1             0             0             0             0             0
Period Title: Period 2
Started 0 [1] 36 36 41 0 [2] 38
Completed 0 36 35 41 0 38
Not Completed 0 0 1 0 0 0
Reason Not Completed
Physician Decision             0             0             1             0             0             0
[1]
Participants switched to either 10 mg prasugrel or 75 mg clopidogrel in Period 2.
[2]
Participants switched to either 5 mg prasugrel or 75 mg clopidogrel in Period 2.
Period Title: Period 3
Started 0 35 [1] 36 [2] 38 [3] 0 41 [4]
Completed 0 34 35 37 0 41
Not Completed 0 1 1 1 0 0
Reason Not Completed
Adverse Event             0             1             1             0             0             0
Withdrawal by Subject             0             0             0             1             0             0
[1]
Participants who received 75 mg clopidogrel in Period 2 received 10 mg prasugrel in Period 3
[2]
Participants who received 10 mg prasugrel in Period 2 received 75 mg clopidogrel in Period 3
[3]
Participants who received 75 mg clopidogrel in Period 2 received 5 mg prasugrel in Period 3
[4]
Participants who received 5 mg prasugrel in Period 2 received 75 mg clopidogrel in Period 3
Arm/Group Title Very Elderly, Drug Sequence ABC Very Elderly; Drug Sequence ACB Non-Elderly; Drug Sequence BAC Non-Elderly; Drug Sequence BCA Total
Hide Arm/Group Description Participants (≥75 years of age) in this arm received study drug sequence ABC. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg. Participants (≥75 years of age) in this arm received study drug sequence ACB. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg. Participants (≥45 to <65 years of age) in this arm received study drug sequence BAC. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg. Participants (≥45 to <65 years of age) in this arm received study drug sequence BCA. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg. Total of all reporting groups
Overall Number of Baseline Participants 36 37 42 40 155
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 37 participants 42 participants 40 participants 155 participants
79.02  (2.87) 78.74  (3.12) 57.11  (4.75) 55.46  (5.53) 66.94  (12.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 37 participants 42 participants 40 participants 155 participants
Female
8
  22.2%
11
  29.7%
7
  16.7%
10
  25.0%
36
  23.2%
Male
28
  77.8%
26
  70.3%
35
  83.3%
30
  75.0%
119
  76.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 37 participants 42 participants 40 participants 155 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
   2.4%
0
   0.0%
1
   0.6%
Not Hispanic or Latino
8
  22.2%
7
  18.9%
9
  21.4%
14
  35.0%
38
  24.5%
Unknown or Not Reported
28
  77.8%
30
  81.1%
32
  76.2%
26
  65.0%
116
  74.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 37 participants 42 participants 40 participants 155 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   2.8%
3
   8.1%
1
   2.4%
7
  17.5%
12
   7.7%
White
35
  97.2%
34
  91.9%
40
  95.2%
32
  80.0%
141
  91.0%
More than one race
0
   0.0%
0
   0.0%
1
   2.4%
1
   2.5%
2
   1.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 37 participants 42 participants 40 participants 155 participants
United States 8 7 10 14 39
Ireland 3 3 7 6 19
Netherlands 3 4 2 1 10
Sweden 22 23 23 19 87
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 36 participants 37 participants 42 participants 40 participants 155 participants
88.49  (10.92) 82.30  (10.74) 92.85  (20.01) 93.36  (17.32) 89.45  (16.01)
Tobacco Use Status at Baseline  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 37 participants 42 participants 40 participants 155 participants
Yes 4 1 13 11 29
No 32 36 29 29 126
1.Primary Outcome
Title Change in Maximum Platelet Aggregation (MPA) to 20 Micromoles (μM) Adenosine Diphosphate (ADP) as Measured by Light Transmission Aggregometry (LTA) From Baseline to 12 Days of Therapy in the First Treatment Period
Hide Description Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). Lower MPA values reflect stronger platelet inhibition, whereas higher MPA values reflect weaker inhibition.
Time Frame Baseline, 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who continued in the study through the Day 12 visit, and who had at least 1 evaluable PD assessment at the Day 12 visit. Participants were analysed based on randomized treatment assignment, regardless of the study drug they took.
Arm/Group Title 5 mg Prasugrel (Elderly) 10 mg Prasugrel (Non-Elderly)
Hide Arm/Group Description:
Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
Overall Number of Participants Analyzed 72 79
Median (Inter-Quartile Range)
Unit of Measure: percentage of aggregation
Baseline
78.00
(72.00 to 83.50)
75.00
(71.00 to 83.00)
Period 1 (12 days) (n=71, 79)
58.00
(50.00 to 65.00)
46.00
(39.00 to 52.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5 mg Prasugrel (Elderly), 10 mg Prasugrel (Non-Elderly)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The difference of median MPA to 20 μM ADP of a prasugrel 5-mg in the elderly group to the 75th percentile of the MPA to 20 μM ADP of a prasugrel 10 mg MD in the non-elderly group at the end of Period 1 was estimated from the observed data. The upper limit of the one-sided 97.5% confidence interval for the difference was estimated from resampling data with replacement through bootstrap methodology and was used to compare with the non-inferiority margin of 15 percentage points.
Method of Estimation Estimation Parameter Estimate of the difference
Estimated Value 6.00
Confidence Interval (2-Sided) 95%
1.00 to 9.00
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Vasodilator-associated Stimulated Phosphoprotein (VASP) From Baseline to 12 Days of Therapy
Hide Description Vasodilator-associated stimulated phosphoprotein (VASP) phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12, whereas a higher PRI reflects weaker inhibition of P2Y12.
Time Frame Baseline, Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.
Arm/Group Title 5 mg Prasugrel (Elderly) 10 mg Prasugrel (Elderly) 75 mg Clopidogrel (Elderly) 5 mg Prasugrel (Non-Elderly) 10 mg Prasugrel (Non-Elderly) 75 mg Clopidogrel (Non-Elderly)
Hide Arm/Group Description:
Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
Overall Number of Participants Analyzed 72 70 71 78 79 79
Mean (Standard Deviation)
Unit of Measure: percentage platelet reactive index (PRI)
Baseline (n=68, 66, 67, 71, 72, 72) 85.62  (4.28) 85.66  (4.32) 85.60  (4.31) 86.10  (5.31) 86.18  (5.32) 86.18  (5.32)
Day 12 (n=67, 65, 67, 73, 74, 73) 44.30  (18.87) 22.66  (11.90) 54.95  (18.86) 54.72  (18.67) 27.74  (15.84) 54.53  (21.82)
3.Secondary Outcome
Title Change in VerifyNow P2Y12 Reaction Units (PRU) From Baseline to 12 Days of Therapy
Time Frame Baseline, Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.
Arm/Group Title 5 mg Prasugrel (Elderly) 10 mg Prasugrel (Elderly) 75 mg Clopidogrel (Elderly) 5 mg Prasugrel (Non-Elderly) 10 mg Prasugrel (Non-Elderly) 75 mg Clopidogrel (Non-Elderly)
Hide Arm/Group Description:
Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
Overall Number of Participants Analyzed 72 70 71 78 79 79
Mean (Standard Deviation)
Unit of Measure: P2Y12 reaction units (PRU)
Baseline 315.63  (45.98) 314.11  (45.74) 314.14  (44.54) 291.81  (45.16) 291.62  (44.90) 291.62  (44.90)
Day 12 (n=71, 67, 69, 77, 79, 79) 175.52  (57.19) 84.13  (47.72) 212.33  (69.65) 177.01  (67.29) 85.46  (60.24) 181.22  (71.80)
4.Secondary Outcome
Title Active Metabolite Blood Levels to Drug Exposure as Measured by Pharmacokinetics (PK) Through 4 Hours After Dosing
Hide Description A descriptive pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing prasugrel and clopidogrel active metabolite exposures to MPA in response to 20 µM ADP (by LTA) was conducted as originally intended; however, the graphic output from that analysis is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours [AUC (0-4)] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances.
Time Frame Baseline up to 4 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All available PK sample data from all treated participants who contributed complete PK profiles.
Arm/Group Title 5 mg Prasugrel (Elderly) 10 mg Prasugrel (Elderly) 75 mg Clopidogrel (Elderly) 5 mg Prasugrel (Non-Elderly) 10 mg Prasugrel (Non-Elderly) 75 mg Clopidogrel (Non-Elderly)
Hide Arm/Group Description:
Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
Overall Number of Participants Analyzed 71 70 70 78 80 79
Overall Number of Units Analyzed
Type of Units Analyzed: Participant PK Profiles
71 101 103 114 80 118
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour/milliliter (ng*hr/mL)
18.9
(43%)
41.2
(35%)
13.0
(62%)
16.1
(54%)
36.7
(49%)
11.8
(68%)
5.Secondary Outcome
Title Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) From Baseline at Day 12 of Therapy
Hide Description Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.
Time Frame Baseline, Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.
Arm/Group Title 5 mg Prasugrel (Elderly) 10 mg Prasugrel (Elderly) 75 mg Clopidogrel (Elderly) 5 mg Prasugrel (Non-Elderly) 10 mg Prasugrel (Non-Elderly) 75 mg Clopidogrel (Non-Elderly)
Hide Arm/Group Description:
Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
Overall Number of Participants Analyzed 72 70 71 78 79 79
Mean (Standard Deviation)
Unit of Measure: percentage of aggregation
Baseline 79.10  (9.73) 78.75  (9.53) 79.11  (9.80) 76.61  (8.07) 76.61  (8.02) 76.61  (8.02)
Day 12 (n=71, 70, 70, 78, 79, 79) 57.05  (13.98) 45.54  (11.07) 63.08  (13.73) 56.83  (11.62) 45.83  (11.82) 59.09  (13.44)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 5 mg Prasugrel (Elderly) 10 mg Prasugrel (Elderly) 75 mg Clopidogrel (Elderly) 5 mg Prasugrel (Non-Elderly) 10 mg Prasugrel (Non-Elderly) 75 mg Clopidogrel (Non-Elderly)
Hide Arm/Group Description Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2. Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3. Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3. Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3. Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2. Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
All-Cause Mortality
5 mg Prasugrel (Elderly) 10 mg Prasugrel (Elderly) 75 mg Clopidogrel (Elderly) 5 mg Prasugrel (Non-Elderly) 10 mg Prasugrel (Non-Elderly) 75 mg Clopidogrel (Non-Elderly)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
5 mg Prasugrel (Elderly) 10 mg Prasugrel (Elderly) 75 mg Clopidogrel (Elderly) 5 mg Prasugrel (Non-Elderly) 10 mg Prasugrel (Non-Elderly) 75 mg Clopidogrel (Non-Elderly)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/73 (0.00%)      2/71 (2.82%)      2/72 (2.78%)      0/79 (0.00%)      2/82 (2.44%)      0/79 (0.00%)    
Blood and lymphatic system disorders             
Eosinophilia  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Cardiac disorders             
Cardiac failure congestive  1  0/73 (0.00%)  0 1/71 (1.41%)  1 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Coronary artery disease  1  0/73 (0.00%)  0 1/71 (1.41%)  1 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Gastrointestinal disorders             
Pancreatitis  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Small intestinal haemorrhage  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Infections and infestations             
Endocarditis  1  0/73 (0.00%)  0 1/71 (1.41%)  1 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Renal and urinary disorders             
Haematuria  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
5 mg Prasugrel (Elderly) 10 mg Prasugrel (Elderly) 75 mg Clopidogrel (Elderly) 5 mg Prasugrel (Non-Elderly) 10 mg Prasugrel (Non-Elderly) 75 mg Clopidogrel (Non-Elderly)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/73 (27.40%)      31/71 (43.66%)      25/72 (34.72%)      23/79 (29.11%)      39/82 (47.56%)      23/79 (29.11%)    
Blood and lymphatic system disorders             
Anaemia  1  0/73 (0.00%)  0 1/71 (1.41%)  1 1/72 (1.39%)  1 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Haemorrhagic diathesis  1  1/73 (1.37%)  1 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Thrombocytopenia  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Cardiac disorders             
Atrial fibrillation  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 1/79 (1.27%)  1
Coronary artery disease  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Palpitations  1  0/73 (0.00%)  0 1/71 (1.41%)  1 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Ear and labyrinth disorders             
Ear pain  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 1/79 (1.27%)  1
Eye disorders             
Eye haemorrhage  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Ocular hypertension  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Gastrointestinal disorders             
Abdominal discomfort  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Abdominal distension  1  0/73 (0.00%)  0 1/71 (1.41%)  1 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Abdominal pain upper  1  1/73 (1.37%)  1 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Constipation  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Diarrhoea  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Faeces discoloured  1  1/73 (1.37%)  1 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Gingival bleeding  1  0/73 (0.00%)  0 2/71 (2.82%)  2 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Melaena  1  0/73 (0.00%)  0 1/71 (1.41%)  1 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Nausea  1  0/73 (0.00%)  0 2/71 (2.82%)  2 1/72 (1.39%)  1 1/79 (1.27%)  1 2/82 (2.44%)  2 0/79 (0.00%)  0
General disorders             
Chest pain  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Fatigue  1  0/73 (0.00%)  0 2/71 (2.82%)  2 2/72 (2.78%)  2 0/79 (0.00%)  0 0/82 (0.00%)  0 1/79 (1.27%)  1
Inflammation  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Infusion site haemorrhage  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Oedema peripheral  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 1/79 (1.27%)  1 1/82 (1.22%)  1 0/79 (0.00%)  0
Pain  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 1/79 (1.27%)  1
Pyrexia  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 1/79 (1.27%)  1 1/82 (1.22%)  1 0/79 (0.00%)  0
Hepatobiliary disorders             
Hepatic cyst  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Infections and infestations             
Nasopharyngitis  1  1/73 (1.37%)  1 0/71 (0.00%)  0 0/72 (0.00%)  0 3/79 (3.80%)  3 2/82 (2.44%)  2 4/79 (5.06%)  4
Pyelonephritis  1  1/73 (1.37%)  1 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Staphylococcal infection  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 1/79 (1.27%)  1 0/82 (0.00%)  0 1/79 (1.27%)  1
Upper respiratory tract infection  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Urinary tract infection  1  1/73 (1.37%)  1 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Injury, poisoning and procedural complications             
Contusion  1  5/73 (6.85%)  6 9/71 (12.68%)  12 4/72 (5.56%)  9 1/79 (1.27%)  1 6/82 (7.32%)  6 4/79 (5.06%)  4
Ear abrasion  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Periorbital haematoma  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Traumatic haematoma  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Wound  1  1/73 (1.37%)  1 0/71 (0.00%)  0 1/72 (1.39%)  2 0/79 (0.00%)  0 0/82 (0.00%)  0 2/79 (2.53%)  2
Investigations             
Alanine aminotransferase increased  1  0/73 (0.00%)  0 1/71 (1.41%)  1 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Aspartate aminotransferase increased  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Bleeding time prolonged  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Blood alkaline phosphatase increased  1  0/73 (0.00%)  0 1/71 (1.41%)  1 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Blood creatine phosphokinase increased  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 1/79 (1.27%)  1 0/82 (0.00%)  0 2/79 (2.53%)  2
Blood creatinine  1  0/73 (0.00%)  0 1/71 (1.41%)  1 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Blood potassium decreased  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 1/79 (1.27%)  1
Blood urea  1  0/73 (0.00%)  0 1/71 (1.41%)  1 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Blood urine present  1  0/73 (0.00%)  0 1/71 (1.41%)  2 1/72 (1.39%)  1 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Cardiac enzymes increased  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 1/79 (1.27%)  1 0/82 (0.00%)  0 0/79 (0.00%)  0
Eosinophil count increased  1  0/73 (0.00%)  0 1/71 (1.41%)  1 1/72 (1.39%)  1 1/79 (1.27%)  1 0/82 (0.00%)  0 1/79 (1.27%)  1
Haematocrit decreased  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 1/79 (1.27%)  1 0/82 (0.00%)  0 0/79 (0.00%)  0
Haemoglobin decreased  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 1/79 (1.27%)  1 0/82 (0.00%)  0 0/79 (0.00%)  0
Metabolism and nutrition disorders             
Gout  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Hypokalaemia  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 1/79 (1.27%)  1 0/82 (0.00%)  0 0/79 (0.00%)  0
Increased appetite  1  0/73 (0.00%)  0 1/71 (1.41%)  1 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Back pain  1  2/73 (2.74%)  2 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Joint swelling  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Musculoskeletal stiffness  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Pain in extremity  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Spinal column stenosis  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Bladder neoplasm  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Nervous system disorders             
Burning sensation  1  0/73 (0.00%)  0 1/71 (1.41%)  1 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Dizziness  1  0/73 (0.00%)  0 1/71 (1.41%)  1 1/72 (1.39%)  1 1/79 (1.27%)  1 3/82 (3.66%)  3 0/79 (0.00%)  0
Dysgeusia  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Headache  1  1/73 (1.37%)  1 2/71 (2.82%)  3 1/72 (1.39%)  1 1/79 (1.27%)  1 3/82 (3.66%)  3 0/79 (0.00%)  0
Migraine  1  0/73 (0.00%)  0 1/71 (1.41%)  1 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Presyncope  1  1/73 (1.37%)  1 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Restless legs syndrome  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 1/82 (1.22%)  1 0/79 (0.00%)  0
Sciatica  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 1/79 (1.27%)  1 0/82 (0.00%)  0 0/79 (0.00%)  0
Psychiatric disorders             
Restlessness  1  1/73 (1.37%)  1 1/71 (1.41%)  1 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Renal and urinary disorders             
Haematuria  1  0/73 (0.00%)  0 1/71 (1.41%)  4 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Pollakiuria  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 1/79 (1.27%)  1 1/82 (1.22%)  1 0/79 (0.00%)  0
Renal impairment  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Reproductive system and breast disorders             
Vaginal haemorrhage  1  1/73 (1.37%)  1 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Asthma  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 1/79 (1.27%)  2 0/82 (0.00%)  0 0/79 (0.00%)  0
Bronchitis chronic  1  0/73 (0.00%)  0 1/71 (1.41%)  1 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Cough  1  1/73 (1.37%)  1 0/71 (0.00%)  0 1/72 (1.39%)  1 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Dry throat  1  1/73 (1.37%)  1 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Epistaxis  1  2/73 (2.74%)  2 0/71 (0.00%)  0 0/72 (0.00%)  0 1/79 (1.27%)  1 5/82 (6.10%)  5 1/79 (1.27%)  1
Oropharyngeal pain  1  1/73 (1.37%)  1 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 1/79 (1.27%)  1
Skin and subcutaneous tissue disorders             
Cold sweat  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Ecchymosis  1  2/73 (2.74%)  2 3/71 (4.23%)  6 1/72 (1.39%)  1 2/79 (2.53%)  2 4/82 (4.88%)  6 3/79 (3.80%)  3
Hyperhidrosis  1  1/73 (1.37%)  1 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Nail disorder  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 1/79 (1.27%)  1
Petechiae  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  3 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Rash  1  0/73 (0.00%)  0 0/71 (0.00%)  0 1/72 (1.39%)  1 0/79 (0.00%)  0 0/82 (0.00%)  0 0/79 (0.00%)  0
Skin haemorrhage  1  0/73 (0.00%)  0 0/71 (0.00%)  0 0/72 (0.00%)  0 1/79 (1.27%)  1 1/82 (1.22%)  2 0/79 (0.00%)  0
Vascular disorders             
Haematoma  1  1/73 (1.37%)  1 9/71 (12.68%)  10 2/72 (2.78%)  4 5/79 (6.33%)  6 9/82 (10.98%)  10 3/79 (3.80%)  5
Hypertension  1  1/73 (1.37%)  1 0/71 (0.00%)  0 0/72 (0.00%)  0 0/79 (0.00%)  0 0/82 (0.00%)  0 1/79 (1.27%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01107912     History of Changes
Other Study ID Numbers: 12835
H7T-MC-TACY ( Other Identifier: Eli Lilly and Company )
First Submitted: April 19, 2010
First Posted: April 21, 2010
Results First Submitted: September 27, 2012
Results First Posted: October 26, 2012
Last Update Posted: October 26, 2012