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Comparison of Prasugrel and Clopidogrel in Low Body Weight Versus Higher Body Weight With Coronary Artery Disease (FEATHER)

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ClinicalTrials.gov Identifier: NCT01107925
Recruitment Status : Completed
First Posted : April 21, 2010
Results First Posted : August 30, 2012
Last Update Posted : August 30, 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 72
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 5 mg Prasugrel (LBW) 10 mg Prasugrel (LBW) 75 mg Clopidogrel (LBW) 5 mg Prasugrel (HBW) 10 mg Prasugrel (HBW) 75 mg Clopidogrel (HBW)
Hide Arm/Group Description During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2. Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3. Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
Period Title: Period 1-Randomization up Through Day 12
Started 34 0 0 0 38 0
Took at Least 1 Dose of Study Drug 34 0 0 0 38 0
Completed 33 0 0 0 37 0
Not Completed 1 0 0 0 1 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0             1             0
Period Title: Period 2
Started 0 [1] 16 17 20 0 [2] 17
Took at Least 1 Dose of Study Drug 0 16 17 20 0 17
Completed 0 15 17 20 0 16
Not Completed 0 1 0 0 0 1
Reason Not Completed
Withdrawal by Subject             0             1             0             0             0             1
[1]
5 mg prasugrel (Period 1, LBW treatment) switched to 10 mg prasugrel or 75 mg clopidogrel (Period 2)
[2]
10 mg prasugrel (Period 1, HBW treatment) switched to 5 mg prasugrel or 75 mg clopidogrel (Period 2)
Period Title: Period 3
Started 0 17 [1] 15 [2] 16 [3] 0 20 [4]
Took at Least 1 Dose of Study Drug 0 17 15 16 0 20
Completed 0 17 15 16 0 20
Not Completed 0 0 0 0 0 0
[1]
75 mg clopidogrel (Period 2, LBW treatment sequence) crossed over to 10 mg prasugrel (Period 3).
[2]
10 mg prasugrel (Period 2, LBW treatment sequence) crossed over to 75 mg clopidogrel (Period 3).
[3]
75 mg clopidogrel (Period 2, HBW treatment sequence) crossed over to 5 mg prasugrel (Period 3).
[4]
5 mg prasugrel (Period 2, HBW treatment sequence) crossed over to 75 mg clopidogrel (Period 3).
Arm/Group Title Dose Sequence: Pras 5mg, Pras 10mg, Clop 75mg (LBW) Dose Sequence: Pras 5mg, Clop 75 mg, Pras 10mg (LBW) Dose Sequence: Pras 10mg, Pras 5mg, Clop 75 mg (HBW) Dose Sequence: Pras 10mg, Clop 75 mg, Pras 5mg (HBW) Total
Hide Arm/Group Description Participants in the low body weight (LBW; <60 kilograms [kg]) group received 5 milligrams (mg) of Prasugrel (Pras) during Study Period 1, followed by 10 mg Pras in Study Period 2, followed by 75 mg clopidogrel (Clop) in Study Period 3. Participants in the LBW group received 5 mg Pras during Study Period 1, followed by 75 mg Clop in Study Period 2, and 10 mg Pras in Study Period 3. Participants in the higher body weight (HBW; ≥60 kg) group received 10 mg Pras during Study Period 1, followed by 5 mg Pras in Study Period 2, followed by 75 mg Clop in Study Period 3. Participants in the HBW group received 10 mg Pras during Study Period 1, followed by 5 mg Pras in Study Period 2, followed by 75 mg Clop in Study Period 3. Total of all reporting groups
Overall Number of Baseline Participants 17 17 21 17 72
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 21 participants 17 participants 72 participants
61.3  (8.07) 63.2  (7.65) 61.4  (9.57) 64.6  (6.91) 62.6  (8.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 21 participants 17 participants 72 participants
Female
15
  88.2%
14
  82.4%
7
  33.3%
5
  29.4%
41
  56.9%
Male
2
  11.8%
3
  17.6%
14
  66.7%
12
  70.6%
31
  43.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 21 participants 17 participants 72 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
10
  58.8%
8
  47.1%
11
  52.4%
8
  47.1%
37
  51.4%
Unknown or Not Reported
7
  41.2%
9
  52.9%
10
  47.6%
9
  52.9%
35
  48.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 21 participants 17 participants 72 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%
1
   5.9%
0
   0.0%
0
   0.0%
1
   1.4%
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
0
   0.0%
0
   0.0%
1
   4.8%
3
  17.6%
4
   5.6%
White
17
 100.0%
16
  94.1%
20
  95.2%
14
  82.4%
67
  93.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
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 17 participants 17 participants 21 participants 17 participants 72 participants
United States 0 0 2 2 4
Ireland 2 2 8 6 18
Netherlands 9 8 5 5 27
Sweden 6 7 6 4 23
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 17 participants 17 participants 21 participants 17 participants 72 participants
56.06  (4.575) 56.78  (2.619) 83.60  (17.146) 85.96  (11.898) 71.33  (17.980)
Tobacco Use Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 21 participants 17 participants 72 participants
Tobacco Use Yes 7 8 5 4 24
Tobacco Use No 10 9 16 13 48
1.Primary Outcome
Title Change From Baseline in Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 (Period 1)
Hide Description MPA to 20 micromolar (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 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
Primary intent-to-treat (ITT) pharmacodynamic (PD) population: all randomized participants who continued in the study through Day 12, and had at least 1 evaluable PD assessment at Day 12. Participants were analyzed based on the treatment group they were randomized to irrespective to the treatment they received.
Arm/Group Title Prasugrel 5 mg (LBW) Prasugrel 10 mg (HBW)
Hide Arm/Group Description:
Participants in the low body weight (LBW; <60 kilograms [kg]) group received the 5-milligram (mg) prasugrel dose in Study Period 1.
Participants in the higher body weight (HBW; ≥60 kg) group received the 10-mg prasugrel dose in Study Period 1.
Overall Number of Participants Analyzed 33 37
Median (Inter-Quartile Range)
Unit of Measure: percent aggregation
Baseline
75.00
(70.00 to 80.00)
76.40
(71.00 to 84.10)
Day 12 (n=32, 37)
47.00
(37.70 to 56.45)
47.00
(39.00 to 57.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel 5 mg (LBW), Prasugrel 10 mg (HBW)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Difference in median MPA in response to 20 μM ADP in LBW participants who received 5 mg prasugrel to the 75th percentile of MPA response to 20 μM ADP in HBW participants who received10 mg prasugrel at the end of Study Period 1 (Baseline through Day 12) was estimated from the observed data.
Statistical Test of Hypothesis P-Value 0.526
Comments [Not Specified]
Method bootstrap (to determine 95% CI)
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of the difference
Estimated Value -10.10
Confidence Interval (2-Sided) 95%
-23.40 to 0.20
Estimation Comments Estimate of the difference = [median (low body weight) - Q3 (higher body weight)]
2.Secondary Outcome
Title Change From Baseline in Vasodilator-Associated Stimulated Phosphoprotein (VASP) at Day 12 of Therapy
Hide Description VASP phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition and were used to compare prasugrel versus clopidogrel, in low body weight (LBW) participants compared to higher body weight (HBW) participants. PRI was calculated by VASP. The PRI indicates the level of P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12 receptor thus stronger platelet inhibition, whereas a higher PRI reflects weaker inhibition of P2Y12 receptor and weaker platelet inhibition.
Time Frame Baseline, Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated pharmacodynamic (PD) population: all randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable 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 (LBW) 10 mg Prasugrel (LBW) 75 mg Clopidogrel (LBW) 5 mg Prasugrel (HBW) 10 mg Prasugrel (HBW) 75 mg Clopidogrel (HBW)
Hide Arm/Group Description:
During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 75-mg clopidogrel or 5-mg prasugrel dose either during Study Period 2 or Study Period 3.
Overall Number of Participants Analyzed 33 32 32 36 37 36
Mean (Standard Deviation)
Unit of Measure: percentage PRI
Baseline 86.57  (4.44) 86.44  (4.45) 86.44  (4.45) 86.77  (3.42) 86.76  (3.37) 86.77  (3.42)
Day 12 (n=32,31,30,32,36,34) 33.54  (15.77) 15.09  (11.71) 39.01  (17.49) 56.87  (15.47) 27.79  (18.13) 56.35  (18.33)
3.Secondary Outcome
Title Change From Baseline in VerifyNow® P2Y12 Reaction Units (PRU) at Day 12 of Therapy
Time Frame Baseline, Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated pharmacodynamic (PD) population: all randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable 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 (LBW) 10 mg Prasugrel (LBW) 75 mg Clopidogrel (LBW) 5 mg Prasugrel (HBW) 10 mg Prasugrel (HBW) 75 mg Clopidogrel (HBW)
Hide Arm/Group Description:
During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; (<60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 75-mg clopidogrel or 5-mg prasugrel dose during Study Period 2 or Study Period 3.
Overall Number of Participants Analyzed 33 32 32 36 37 36
Mean (Standard Deviation)
Unit of Measure: P2Y12 reaction units (PRU)
Baseline 317.9  (46.10) 315.3  (44.26) 315.3  (44.26) 312.8  (43.01) 311.0  (43.76) 312.8  (43.01)
Day 12 (n=32,31,32,35,34,34) 129.5  (62.14) 55.9  (38.08) 151.7  (57.46) 193.9  (74.09) 102.1  (69.49) 207.0  (67.62)
4.Secondary Outcome
Title Pharmacokinetic (PK) Analysis of the Concentration-Time Curve (AUC)
Hide Description A pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing MPA (LTA) and AUC was conducted as originally intended, however the graphic output 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 (pre-dose) 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 Prasugrel 5 mg (LBW) Prasugrel 10 mg (LBW) Clopidogrel 75 mg (LBW) Prasugrel 5 mg (HBW) Prasugrel 10 mg (HBW) Clopidogrel 75 mg (HBW)
Hide Arm/Group Description:
During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
Participants in the higher body weight (HBW; ≥ 60 kg)treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
Participants in the HBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
Overall Number of Participants Analyzed 34 33 30 36 38 37
Overall Number of Units Analyzed
Type of Units Analyzed: Participant Profiles
34 50 45 52 38 57
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram•hour/milliliter (ng•hr/mL)
28.9
(37%)
59.3
(40%)
18.4
(38%)
19.4
(46%)
46.7
(44%)
12.7
(60%)
5.Secondary Outcome
Title Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) at Day 12 of Therapy
Hide Description MPA to 20 micromolar (μM) adenosine diphosphate (ADP) was assessed by LTA, an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing 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
As-treated pharmacodynamic (PD) population: all randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable 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 (LBW) 10 mg Prasugrel (LBW) 75 mg Clopidogrel (LBW) 5 mg Prasugrel (HBW) 10 mg Prasugrel (HBW) 75 mg Clopidogrel (HBW)
Hide Arm/Group Description:
During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
Participants in the LBW treatment sequence in Period 1 (on 5 mg prasugrel) were switched to either the 10-mg prasugrel or the 75-mg clopidogrel dose for Period 2 or Period 3.
Participants in the higher body weight (HBW; ≥ 60 kg)treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
During Study Period 1, participants in the (HBW; ≥ 60 kg) treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either 5-mg prasugrel or the 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
Overall Number of Participants Analyzed 33 32 32 36 37 36
Mean (Standard Deviation)
Unit of Measure: percent aggregation
Baseline 76.27  (9.49) 76.20  (9.63) 76.20  (9.63) 77.63  (12.29) 77.93  (12.27) 77.63  (12.29)
Day 12 ( n= 32,32,31,35,37,35) 48.10  (13.89) 38.11  (14.17) 51.41  (13.56) 61.90  (18.93) 47.92  (15.18) 65.28  (17.83)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 5 mg Prasugrel (LBW) 10 mg Prasugrel (LBW) 75 mg Clopidogrel (LBW) 5 mg Prasugrel (HBW) 10 mg Prasugrel (HBW) 75 mg Clopidogrel (HBW)
Hide Arm/Group Description During Study Period 1, participants received 5 milligrams (mg) prasugrel for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2. Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3. Participants in the higher body weight (HBW; ≥ 60 mg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3. During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
All-Cause Mortality
5 mg Prasugrel (LBW) 10 mg Prasugrel (LBW) 75 mg Clopidogrel (LBW) 5 mg Prasugrel (HBW) 10 mg Prasugrel (HBW) 75 mg Clopidogrel (HBW)
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 (LBW) 10 mg Prasugrel (LBW) 75 mg Clopidogrel (LBW) 5 mg Prasugrel (HBW) 10 mg Prasugrel (HBW) 75 mg Clopidogrel (HBW)
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   0/34 (0.00%)      1/33 (3.03%)      0/32 (0.00%)      0/36 (0.00%)      0/38 (0.00%)      0/37 (0.00%)    
Nervous system disorders             
Subarachnoid haemorrhage  1 [1]  0/34 (0.00%)  0 1/33 (3.03%)  1 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
[1]
This event occurred after study completion, but within the 30 day follow-up period. This was the last treatment assigned for this participant.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
5 mg Prasugrel (LBW) 10 mg Prasugrel (LBW) 75 mg Clopidogrel (LBW) 5 mg Prasugrel (HBW) 10 mg Prasugrel (HBW) 75 mg Clopidogrel (HBW)
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   20/34 (58.82%)      21/33 (63.64%)      14/32 (43.75%)      10/36 (27.78%)      12/38 (31.58%)      14/37 (37.84%)    
Blood and lymphatic system disorders             
Anaemia  1  1/34 (2.94%)  1 0/33 (0.00%)  0 0/32 (0.00%)  0 1/36 (2.78%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0
Macrocytosis  1  1/34 (2.94%)  1 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Spontaneous haematoma  1  0/34 (0.00%)  0 1/33 (3.03%)  2 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Thrombocytopenia  1  1/34 (2.94%)  1 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Cardiac disorders             
Atrioventricular block first degree  1  0/34 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1
Palpitations  1  1/34 (2.94%)  2 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Eye disorders             
Conjunctival haemorrhage  1  0/34 (0.00%)  0 1/33 (3.03%)  1 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Gastrointestinal disorders             
Abdominal discomfort  1  0/34 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Abdominal pain upper  1  0/34 (0.00%)  0 0/33 (0.00%)  0 1/32 (3.13%)  1 0/36 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Constipation  1  0/34 (0.00%)  0 0/33 (0.00%)  0 1/32 (3.13%)  1 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Diarrhoea  1  0/34 (0.00%)  0 0/33 (0.00%)  0 1/32 (3.13%)  1 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Eructation  1  0/34 (0.00%)  0 1/33 (3.03%)  1 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Haematochezia  1  1/34 (2.94%)  1 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Nausea  1  2/34 (5.88%)  2 0/33 (0.00%)  0 1/32 (3.13%)  1 0/36 (0.00%)  0 2/38 (5.26%)  3 2/37 (5.41%)  2
Vomiting  1  1/34 (2.94%)  1 0/33 (0.00%)  0 1/32 (3.13%)  1 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
General disorders             
Chest pain  1  1/34 (2.94%)  1 1/33 (3.03%)  1 1/32 (3.13%)  3 1/36 (2.78%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0
Fatigue  1  0/34 (0.00%)  0 0/33 (0.00%)  0 1/32 (3.13%)  1 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Feeling abnormal  1  1/34 (2.94%)  1 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Influenza like illness  1  0/34 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 1/36 (2.78%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0
Obstruction  1  1/34 (2.94%)  1 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Pyrexia  1  2/34 (5.88%)  2 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Infections and infestations             
Nasopharyngitis  1  3/34 (8.82%)  3 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Rhinitis  1  0/34 (0.00%)  0 0/33 (0.00%)  0 1/32 (3.13%)  1 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Sinusitis  1  0/34 (0.00%)  0 0/33 (0.00%)  0 1/32 (3.13%)  1 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Injury, poisoning and procedural complications             
Contusion  1  6/34 (17.65%)  6 9/33 (27.27%)  9 1/32 (3.13%)  1 0/36 (0.00%)  0 3/38 (7.89%)  3 2/37 (5.41%)  2
Limb injury  1  0/34 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Periorbital haematoma  1  0/34 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1
Traumatic haematoma  1  1/34 (2.94%)  1 1/33 (3.03%)  1 2/32 (6.25%)  3 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Wound  1  0/34 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1
Wound haemorrhage  1  0/34 (0.00%)  0 0/33 (0.00%)  0 1/32 (3.13%)  1 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Investigations             
Blood creatine phosphokinase increased  1  0/34 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Metabolism and nutrition disorders             
Hyperglycaemia  1  0/34 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/34 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  2
Back pain  1  0/34 (0.00%)  0 0/33 (0.00%)  0 1/32 (3.13%)  1 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Exostosis  1  0/34 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Joint swelling  1  0/34 (0.00%)  0 0/33 (0.00%)  0 1/32 (3.13%)  1 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Muscle spasms  1  0/34 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 1/36 (2.78%)  2 0/38 (0.00%)  0 0/37 (0.00%)  0
Musculoskeletal discomfort  1  0/34 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 1/36 (2.78%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0
Myalgia  1  0/34 (0.00%)  0 0/33 (0.00%)  0 1/32 (3.13%)  1 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Nervous system disorders             
Dizziness  1  1/34 (2.94%)  1 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Dizziness postural  1  0/34 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1
Formication  1  1/34 (2.94%)  1 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Headache  1  0/34 (0.00%)  0 0/33 (0.00%)  0 1/32 (3.13%)  2 1/36 (2.78%)  1 2/38 (5.26%)  2 1/37 (2.70%)  1
Paraesthesia  1  0/34 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Presyncope  1  0/34 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1
Renal and urinary disorders             
Haematuria  1  1/34 (2.94%)  1 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Reproductive system and breast disorders             
Menorrhagia  1  0/34 (0.00%)  0 1/33 (3.03%)  1 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Asthma  1  1/34 (2.94%)  1 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Chronic respiratory disease  1  1/34 (2.94%)  1 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Cough  1  2/34 (5.88%)  2 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Dyspnoea  1  0/34 (0.00%)  0 0/33 (0.00%)  0 1/32 (3.13%)  1 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Epistaxis  1  1/34 (2.94%)  2 2/33 (6.06%)  3 1/32 (3.13%)  1 1/36 (2.78%)  1 1/38 (2.63%)  1 2/37 (5.41%)  2
Nasal congestion  1  0/34 (0.00%)  0 1/33 (3.03%)  1 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Skin and subcutaneous tissue disorders             
Hyperhidrosis  1  0/34 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 1/36 (2.78%)  1 1/38 (2.63%)  1 0/37 (0.00%)  0
Pruritus  1  0/34 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 1/36 (2.78%)  1 1/38 (2.63%)  1 0/37 (0.00%)  0
Rash  1  0/34 (0.00%)  0 1/33 (3.03%)  1 1/32 (3.13%)  1 0/36 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Vascular disorders             
Haematoma  1  3/34 (8.82%)  3 5/33 (15.15%)  7 3/32 (9.38%)  7 5/36 (13.89%)  7 3/38 (7.89%)  4 1/37 (2.70%)  3
Hypotension  1  0/34 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1
Intermittent claudication  1  0/34 (0.00%)  0 1/33 (3.03%)  1 0/32 (0.00%)  0 0/36 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
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
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01107925     History of Changes
Other Study ID Numbers: 12921
H7T-MC-TADI ( Other Identifier: Eli Lilly and Company )
First Submitted: April 19, 2010
First Posted: April 21, 2010
Results First Submitted: July 27, 2012
Results First Posted: August 30, 2012
Last Update Posted: August 30, 2012