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Treatment With Adenosine Diphosphate (ADP) Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01088503
Recruitment Status : Completed
First Posted : March 17, 2010
Results First Posted : January 29, 2016
Last Update Posted : January 29, 2016
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Acute Coronary Syndrome
Intervention Drug: ADP receptor inhibitors
Enrollment 12227
Recruitment Details  
Pre-assignment Details Centralized follow-up visits were conducted for all participants. Participants who completed 15-month active follow-up were considered to have completed the study.
Arm/Group Title Prasugrel Clopidogrel Ticlopidine/Ticagrelor
Hide Arm/Group Description Participants who were admitted for non ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI) and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician. Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician. Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with ticlopidine or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician.
Period Title: Overall Study
Started 3123 8846 258
Completed 2941 8161 241
Not Completed 182 685 17
Reason Not Completed
Withdrawal by Subject             118             327             10
Death             64             358             7
Arm/Group Title Prasugrel Clopidogrel Ticlopidine/Ticagrelor Total
Hide Arm/Group Description Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician. Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician. Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with ticlopidine or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician. Total of all reporting groups
Overall Number of Baseline Participants 3123 8846 258 12227
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3123 participants 8846 participants 258 participants 12227 participants
≥75 years 88 1341 33 1462
<75 years 3035 7505 225 10765
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3123 participants 8846 participants 258 participants 12227 participants
Female
672
  21.5%
2671
  30.2%
91
  35.3%
3434
  28.1%
Male
2451
  78.5%
6175
  69.8%
167
  64.7%
8793
  71.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3123 participants 8846 participants 258 participants 12227 participants
Hispanic or Latino
129
   4.1%
271
   3.1%
13
   5.0%
413
   3.4%
Not Hispanic or Latino
2986
  95.6%
8525
  96.4%
244
  94.6%
11755
  96.1%
Unknown or Not Reported
8
   0.3%
50
   0.6%
1
   0.4%
59
   0.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3123 participants 8846 participants 258 participants 12227 participants
American Indian or Alaska Native
35
   1.1%
39
   0.4%
0
   0.0%
74
   0.6%
Asian
55
   1.8%
94
   1.1%
1
   0.4%
150
   1.2%
Native Hawaiian or Other Pacific Islander
12
   0.4%
13
   0.1%
0
   0.0%
25
   0.2%
Black or African American
237
   7.6%
820
   9.3%
30
  11.6%
1087
   8.9%
White
2750
  88.1%
7778
  87.9%
225
  87.2%
10753
  87.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
34
   1.1%
102
   1.2%
2
   0.8%
138
   1.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3123 participants 8846 participants 258 participants 12227 participants
3123 8846 258 12227
1.Primary Outcome
Title Percentage of Participants With Major Adverse Cardiovascular Events (MACE)
Hide Description MACE is defined as a composite of all-cause death, myocardial infarction (MI), stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events in 12 months/ number of participants treated) * 100.
Time Frame Baseline through 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.
Arm/Group Title Prasugrel Clopidogrel
Hide Arm/Group Description:
Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Overall Number of Participants Analyzed 3123 8838
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.14
(11.79 to 14.48)
17.12
(16.25 to 17.98)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7108
Comments Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.88 to 1.22
Estimation Comments [Not Specified]
2.Primary Outcome
Title Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment
Hide Description Factors are drug-eluting stent (DES) vs. bare metal stent (BMS) placement, other (no stent) vs. BMS, STEMI, other race, cardiogenic shock occurred within 24 hours, male, European Quality of Life Questionnaire-5 Dimension Health State Score (EQ-5D) - United States (US) Index =1 vs. <1, married, diabetes, and other vs. BMS placement. The EQ-5D US index is a participant-rated, health-related, quality-of-life instrument based on US population. Scores range from -0.11 to 1.0 with 1.0 = perfect health.
Time Frame Day 0 (study enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Prasugrel Other
Hide Arm/Group Description:
Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician
Overall Number of Participants Analyzed 3123 9104
Measure Type: Number
Unit of Measure: participants
Received DES 2365 6282
Received only BMS 672 2491
STEMI 1831 4508
Other Race (Non-Caucasian) 365 1049
Cardiogenic Shock on Presentation 79 176
Male Participants 2451 6342
EQ-5D US index = 1 vs. <1 1516 3873
Married Participants 2044 5601
Participant has Diabetes 767 2472
No BMS or DES 86 331
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.464
Estimation Comments Odds Ratio for selection of Prasugrel for participants with DES vs BMS.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.230
Estimation Comments Odds Ratio for selection of Prasugrel for participants with STEMI vs not STEMI
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 1.657
Estimation Comments Odds Ratio for selection of Prasugrel for participants who were Other Race vs Caucasian.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 1.684
Estimation Comments Odds Ratio for selection of Prasugrel for participants who had cardiogenic shock within 24 hours vs no cardiogenic shock within 24 hours.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.195
Estimation Comments Odds Ratio for selection of Prasugrel for participants who were male vs not male.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.120
Estimation Comments Odds Ratio for selection of Prasugrel for participants with EQ-5D US index = 1 vs. <1.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.116
Estimation Comments Odds Ratio for selection of Prasugrel for participants who were married vs not married.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.125
Estimation Comments Odds Ratio for selection of Prasugrel for participants who had diabetes vs no diabetes.
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.172
Estimation Comments Odds Ratio for selection of Prasugrel for participants with no BMS or DES placement vs BMS.
3.Primary Outcome
Title Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Pre-Procedure Hemoglobin
Hide Description [Not Specified]
Time Frame Day 0 (study enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who had pre-procedure hemoglobin evaluation.
Arm/Group Title Prasugrel Other
Hide Arm/Group Description:
Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician
Overall Number of Participants Analyzed 2806 8246
Mean (Standard Deviation)
Unit of Measure: grams/deciliter (g/dL)
14.59  (1.702) 14  (1.909)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.050
Estimation Comments Odds Ratio for selection of Prasugrel for participants who had pre-procedure hemoglobin evaluation vs no hemoglobin evaluation.
4.Primary Outcome
Title Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Duke Coronary Artery Disease (CAD) Index
Hide Description The Duke CAD Index is a validated composite measure of angiographic burden, which assigns prognostic weights 1 through 100. Higher scores indicate greater angiographic burden and are associated with poorer prognosis.
Time Frame Day 0 (study enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who had Duke CAD Index completed.
Arm/Group Title Prasugrel Other
Hide Arm/Group Description:
Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician
Overall Number of Participants Analyzed 3101 8923
Mean (Standard Deviation)
Unit of Measure: units on a scale
40.36  (14.43) 41.87  (16.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.005
Estimation Comments Odds Ratio for selection of Prasugrel for participants with Duke CAD Index vs no Duke CAD Index.
5.Secondary Outcome
Title Percentage of Participants With Cumulative Severe or Moderate Bleeding Events
Hide Description Bleeding events were collected utilizing the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) definition of bleeding. Non-coronary artery bypass grafting (CABG)-related GUSTO severe or life-threatening bleeding is any intracranial hemorrhage (ICH) OR any bleeding event resulting in substantial hemodynamic compromise requiring treatment. Non-CABG-related GUSTO moderate bleeding is any bleeding event resulting in the need for transfusion that is not considered a GUSTO severe or life-threatening bleed. Additional bleeding events are fatal bleeding or ICH, or any non -fatal surgical-related bleeding events leading to ≥4 units of red cell transfusion. Observed (unadjusted) percentages of participants with bleeding events, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events / number of participants treated) * 100.
Time Frame Baseline, 1, 6, 12 and 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were treated with prasugrel or clopidogrel. Participants with bleeding events dated prior to index PCI were excluded from the analysis. The analysis was based on the initial treatment assignment, regardless of whether or not the participants switched or discontinued that treatment.
Arm/Group Title Prasugrel Clopidogrel
Hide Arm/Group Description:
Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Overall Number of Participants Analyzed 3123 8833
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Baseline
0.54
(0.34 to 0.87)
0.45
(0.33 to 0.62)
1 month
1.22
(0.89 to 1.67)
1.62
(1.38 to 1.91)
6 months
1.93
(1.50 to 2.48)
2.77
(2.45 to 3.13)
12 months
2.72
(2.20 to 3.36)
3.86
(3.48 to 4.29)
15 months
3.10
(2.55 to 3.79)
4.21
(3.81 to 4.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1882
Comments Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.30
Confidence Interval (2-Sided) 95%
0.88 to 1.93
Estimation Comments Hazard ratio (HR) is for the analysis at 12 months.
6.Secondary Outcome
Title Percentage of Participants With MACE and Who Had No Prior History of Transient Ischemic Attack (TIA)/Stroke, Weigh ≥60 Kilograms (kg), and Are Age <75 Years
Hide Description MACE is defined as a composite of all-cause death, MI, stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participant = (number of participants with events / number of participants treated) * 100.
Time Frame Baseline through 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.
Arm/Group Title Prasugrel Clopidogrel
Hide Arm/Group Description:
Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Overall Number of Participants Analyzed 3123 8838
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.67
(11.3 to 14.03)
15.89
(14.92 to 16.85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.967
Confidence Interval (2-Sided) 95%
0.849 to 1.103
Estimation Comments Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.
7.Secondary Outcome
Title Percentage of Participants With MACE Over 1, 6 and 15 Months
Hide Description MACE is defined as a composite of all-cause death, MI, stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE are presented. Kaplan-Meier analysis was used to estimate the percentage of participants with a MACE event.
Time Frame Baseline through 1, 6 and 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.
Arm/Group Title Prasugrel Clopidogrel
Hide Arm/Group Description:
Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Overall Number of Participants Analyzed 3123 8838
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1 month
4.63
(3.87 to 5.39)
5.40
(4.88 to 5.85)
6 months
9.64
(8.50 to 10.77)
12.04
(11.31 to 12.77)
15 months
14.26
(12.82 to 15.70)
19.13
(18.20 to 20.07)
8.Secondary Outcome
Title Percentage of Participants With Definite or Probable Stent Thrombosis (ST) Events
Hide Description Academic Research Consortium (ARC) criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least 1 of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with ST events are presented. Kaplan-Meier analysis was used to estimate the percentage of participants with a definite or probable ST event.
Time Frame Baseline through 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were treated with prasugrel or clopidogrel.
Arm/Group Title Prasugrel Clopidogrel
Hide Arm/Group Description:
Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Overall Number of Participants Analyzed 3123 8846
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.35
(0.85 to 1.85)
1.79
(1.49 to 2.10)
9.Secondary Outcome
Title Resource Use Patterns, Cumulative Total Medical Costs, and Cost Effectiveness
Hide Description [Not Specified]
Time Frame 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed. Exploratory analysis of resource use patterns, cumulative total medical costs, and cost effectiveness was dependent on effectiveness in the primary outcome. As there was no effectiveness on the primary outcome demonstrated, no analysis of these outcome measure was conducted.
Arm/Group Title Prasugrel Clopidogrel
Hide Arm/Group Description:
Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
 
Arm/Group Title Prasugrel
Hide Arm/Group Description Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
All-Cause Mortality
Prasugrel
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Prasugrel
Affected / at Risk (%) # Events
Total   865/3123 (27.70%)    
Blood and lymphatic system disorders   
Anaemia  1  4/3123 (0.13%)  4
Cardiac disorders   
Acute coronary syndrome  1  1/3123 (0.03%)  1
Acute myocardial infarction  1  26/3123 (0.83%)  26
Angina pectoris  1  23/3123 (0.74%)  23
Angina unstable  1  24/3123 (0.77%)  25
Arrhythmia  1  7/3123 (0.22%)  7
Arteriosclerosis coronary artery  1  25/3123 (0.80%)  25
Atrial fibrillation  1  9/3123 (0.29%)  11
Atrial flutter  1  3/3123 (0.10%)  3
Atrioventricular block complete  1  1/3123 (0.03%)  1
Cardiac arrest  1  7/3123 (0.22%)  7
Cardiac disorder  1  3/3123 (0.10%)  3
Cardiac failure  1  3/3123 (0.10%)  3
Cardiac failure acute  1  7/3123 (0.22%)  7
Cardiac failure congestive  1  19/3123 (0.61%)  22
Cardiac flutter  1  1/3123 (0.03%)  1
Cardiomegaly  1  1/3123 (0.03%)  1
Cardiovascular disorder  1  2/3123 (0.06%)  2
Coronary artery disease  1  3/3123 (0.10%)  3
Coronary artery occlusion  1  6/3123 (0.19%)  6
Dressler's syndrome  1  3/3123 (0.10%)  3
Hypertensive heart disease  1  1/3123 (0.03%)  1
Mitral valve incompetence  1  1/3123 (0.03%)  1
Myocardial infarction  1  109/3123 (3.49%)  136
Myocardial ischaemia  1  1/3123 (0.03%)  1
Palpitations  1  7/3123 (0.22%)  8
Pericardial effusion  1  2/3123 (0.06%)  2
Pericarditis  1  2/3123 (0.06%)  2
Supraventricular tachycardia  1  1/3123 (0.03%)  1
Tachycardia  1  1/3123 (0.03%)  1
Ventricular fibrillation  1  1/3123 (0.03%)  1
Ventricular tachycardia  1  1/3123 (0.03%)  1
Ear and labyrinth disorders   
Ear pain  1  1/3123 (0.03%)  1
Vertigo positional  1  1/3123 (0.03%)  1
Eye disorders   
Amaurosis  1  1/3123 (0.03%)  1
Blindness  1  1/3123 (0.03%)  1
Vitreous floaters  1  1/3123 (0.03%)  1
Gastrointestinal disorders   
Abdominal discomfort  1  4/3123 (0.13%)  4
Abdominal distension  1  1/3123 (0.03%)  1
Abdominal pain  1  7/3123 (0.22%)  7
Abdominal pain upper  1  7/3123 (0.22%)  7
Colitis  1  3/3123 (0.10%)  3
Constipation  1  1/3123 (0.03%)  1
Crohn's disease  1  1/3123 (0.03%)  1
Diarrhoea  1  2/3123 (0.06%)  2
Diverticulum  1  1/3123 (0.03%)  1
Dyspepsia  1  6/3123 (0.19%)  6
Epigastric discomfort  1  1/3123 (0.03%)  1
Faeces discoloured  1  2/3123 (0.06%)  2
Food poisoning  1  2/3123 (0.06%)  2
Gastric disorder  1  1/3123 (0.03%)  1
Gastric haemorrhage  1  3/3123 (0.10%)  3
Gastric ulcer  1  2/3123 (0.06%)  2
Gastric ulcer haemorrhage  1  1/3123 (0.03%)  1
Gastritis  1  3/3123 (0.10%)  4
Gastritis erosive  1  1/3123 (0.03%)  1
Gastroduodenitis  1  1/3123 (0.03%)  1
Gastrointestinal disorder  1  1/3123 (0.03%)  1
Gastrointestinal haemorrhage  1  8/3123 (0.26%)  9
Gastrointestinal inflammation  1  2/3123 (0.06%)  2
Gastrooesophageal reflux disease  1  3/3123 (0.10%)  4
Haematemesis  1  1/3123 (0.03%)  1
Haematochezia  1  3/3123 (0.10%)  4
Haemorrhoidal haemorrhage  1  1/3123 (0.03%)  1
Impaired gastric emptying  1  1/3123 (0.03%)  1
Intestinal obstruction  1  1/3123 (0.03%)  1
Intra-abdominal haemorrhage  1  1/3123 (0.03%)  1
Large intestinal haemorrhage  1  1/3123 (0.03%)  1
Large intestine polyp  1  1/3123 (0.03%)  1
Mallory-weiss syndrome  1  1/3123 (0.03%)  1
Melaena  1  1/3123 (0.03%)  1
Nausea  1  8/3123 (0.26%)  8
Oesophageal haemorrhage  1  2/3123 (0.06%)  2
Oesophageal rupture  1  2/3123 (0.06%)  2
Oesophageal spasm  1  1/3123 (0.03%)  1
Pancreatitis  1  2/3123 (0.06%)  2
Pancreatitis acute  1  1/3123 (0.03%)  1
Rectal haemorrhage  1  1/3123 (0.03%)  1
Small intestinal haemorrhage  1  1/3123 (0.03%)  1
Vomiting  1  10/3123 (0.32%)  10
General disorders   
Adverse drug reaction  1  6/3123 (0.19%)  6
Arterial restenosis  1  1/3123 (0.03%)  1
Asthenia  1  3/3123 (0.10%)  4
Chest discomfort  1  12/3123 (0.38%)  12
Chest pain  1  247/3123 (7.91%)  309
Coronary artery restenosis  1  3/3123 (0.10%)  3
Death  1  50/3123 (1.60%)  53
Device damage  1  1/3123 (0.03%)  1
Device dislocation  1  1/3123 (0.03%)  1
Device failure  1  1/3123 (0.03%)  1
Device issue  1  1/3123 (0.03%)  1
Device malfunction  1  2/3123 (0.06%)  2
Device occlusion  1  6/3123 (0.19%)  6
Effusion  1  2/3123 (0.06%)  2
Fatigue  1  5/3123 (0.16%)  5
Feeling abnormal  1  1/3123 (0.03%)  1
Gait disturbance  1  1/3123 (0.03%)  1
Hyperthermia  1  1/3123 (0.03%)  1
Inflammation  1  1/3123 (0.03%)  1
Malaise  1  3/3123 (0.10%)  4
Non-cardiac chest pain  1  7/3123 (0.22%)  8
Oedema  1  2/3123 (0.06%)  2
Pain  1  2/3123 (0.06%)  2
Peripheral swelling  1  3/3123 (0.10%)  5
Pyrexia  1  2/3123 (0.06%)  2
Stent malfunction  1  4/3123 (0.13%)  4
Swelling  1  1/3123 (0.03%)  1
Systemic inflammatory response syndrome  1  1/3123 (0.03%)  1
Thrombosis in device  1  9/3123 (0.29%)  9
Ulcer haemorrhage  1  7/3123 (0.22%)  7
Unevaluable event  1  3/3123 (0.10%)  3
Vessel puncture site haemorrhage  1  1/3123 (0.03%)  1
Hepatobiliary disorders   
Cholelithiasis  1  1/3123 (0.03%)  1
Gallbladder disorder  1  1/3123 (0.03%)  1
Gallbladder pain  1  1/3123 (0.03%)  1
Immune system disorders   
Drug hypersensitivity  1  8/3123 (0.26%)  8
Infections and infestations   
Abscess  1  1/3123 (0.03%)  1
Abscess limb  1  1/3123 (0.03%)  1
Appendicitis perforated  1  1/3123 (0.03%)  1
Bacterial infection  1  1/3123 (0.03%)  1
Bronchitis  1  7/3123 (0.22%)  7
Cellulitis  1  3/3123 (0.10%)  3
Clostridium difficile colitis  1  1/3123 (0.03%)  2
Clostridium difficile infection  1  1/3123 (0.03%)  1
Cystitis  1  3/3123 (0.10%)  3
Device related infection  1  1/3123 (0.03%)  1
Diverticulitis  1  1/3123 (0.03%)  1
Ear infection  1  1/3123 (0.03%)  1
Escherichia infection  1  2/3123 (0.06%)  2
Gastroenteritis  1  1/3123 (0.03%)  1
Gastrointestinal infection  1  1/3123 (0.03%)  1
Groin infection  1  2/3123 (0.06%)  2
Herpes zoster  1  1/3123 (0.03%)  2
Infection  1  4/3123 (0.13%)  4
Infective exacerbation of chronic obstructive airways disease  1  1/3123 (0.03%)  1
Influenza  1  2/3123 (0.06%)  2
Kidney infection  1  4/3123 (0.13%)  4
Localised infection  1  2/3123 (0.06%)  2
Meningitis  1  1/3123 (0.03%)  1
Orchitis  1  2/3123 (0.06%)  2
Pneumonia  1  21/3123 (0.67%)  22
Sepsis  1  3/3123 (0.10%)  3
Septic shock  1  1/3123 (0.03%)  1
Sinusitis  1  1/3123 (0.03%)  1
Staphylococcal infection  1  1/3123 (0.03%)  1
Urinary tract infection  1  3/3123 (0.10%)  3
Viral infection  1  1/3123 (0.03%)  1
Injury, poisoning and procedural complications   
Abdominal injury  1  1/3123 (0.03%)  1
Ankle fracture  1  1/3123 (0.03%)  1
Chest injury  1  1/3123 (0.03%)  1
Contrast media reaction  1  1/3123 (0.03%)  1
Fall  1  10/3123 (0.32%)  10
Femur fracture  1  1/3123 (0.03%)  1
Fractured coccyx  1  1/3123 (0.03%)  1
Gastrointestinal injury  1  1/3123 (0.03%)  1
Head injury  1  6/3123 (0.19%)  6
Humerus fracture  1  1/3123 (0.03%)  1
Incision site haemorrhage  1  1/3123 (0.03%)  1
Injury  1  1/3123 (0.03%)  1
Intentional overdose  1  1/3123 (0.03%)  1
Joint injury  1  1/3123 (0.03%)  1
Limb injury  1  1/3123 (0.03%)  1
Limb traumatic amputation  1  1/3123 (0.03%)  1
Muscle strain  1  4/3123 (0.13%)  4
Overdose  1  2/3123 (0.06%)  3
Post procedural complication  1  1/3123 (0.03%)  1
Post procedural haematoma  1  1/3123 (0.03%)  1
Procedural complication  1  1/3123 (0.03%)  1
Rib fracture  1  3/3123 (0.10%)  3
Road traffic accident  1  5/3123 (0.16%)  5
Spinal fracture  1  1/3123 (0.03%)  1
Subdural haematoma  1  1/3123 (0.03%)  1
Thermal burn  1  1/3123 (0.03%)  1
Traumatic haematoma  1  1/3123 (0.03%)  1
Vascular pseudoaneurysm  1  4/3123 (0.13%)  5
Investigations   
Angiogram  1  1/3123 (0.03%)  1
Aspiration pleural cavity  1  1/3123 (0.03%)  1
Barium enema  1  1/3123 (0.03%)  1
Biopsy lung  1  1/3123 (0.03%)  1
Blood glucose abnormal  1  2/3123 (0.06%)  3
Blood glucose decreased  1  2/3123 (0.06%)  2
Blood glucose fluctuation  1  1/3123 (0.03%)  1
Blood glucose increased  1  3/3123 (0.10%)  3
Blood potassium decreased  1  2/3123 (0.06%)  2
Blood potassium increased  1  1/3123 (0.03%)  1
Blood pressure decreased  1  4/3123 (0.13%)  4
Blood pressure increased  1  6/3123 (0.19%)  6
Blood triglycerides increased  1  1/3123 (0.03%)  1
Blood urine present  1  2/3123 (0.06%)  2
Cardiac stress test  1  2/3123 (0.06%)  2
Catheterisation cardiac  1  81/3123 (2.59%)  87
Colonoscopy  1  3/3123 (0.10%)  3
Computerised tomogram  1  1/3123 (0.03%)  1
Electrocardiogram  1  1/3123 (0.03%)  1
Electrocardiogram abnormal  1  3/3123 (0.10%)  3
Endoscopy  1  1/3123 (0.03%)  1
Enzyme level increased  1  1/3123 (0.03%)  1
Haemoglobin decreased  1  3/3123 (0.10%)  3
Haemoglobin increased  1  1/3123 (0.03%)  1
Heart rate abnormal  1  1/3123 (0.03%)  1
Heart rate decreased  1  2/3123 (0.06%)  2
Heart rate increased  1  4/3123 (0.13%)  4
Heart rate irregular  1  2/3123 (0.06%)  2
Imaging procedure  1  1/3123 (0.03%)  1
International normalised ratio increased  1  1/3123 (0.03%)  1
Oesophagogastroduodenoscopy  1  1/3123 (0.03%)  1
Metabolism and nutrition disorders   
Dehydration  1  9/3123 (0.29%)  9
Diabetes mellitus  1  4/3123 (0.13%)  5
Diabetic complication  1  2/3123 (0.06%)  2
Diabetic ketoacidosis  1  1/3123 (0.03%)  2
Electrolyte imbalance  1  1/3123 (0.03%)  1
Fluid retention  1  3/3123 (0.10%)  3
Gout  1  1/3123 (0.03%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/3123 (0.10%)  3
Arthropathy  1  1/3123 (0.03%)  1
Back disorder  1  1/3123 (0.03%)  1
Back pain  1  5/3123 (0.16%)  5
Bursitis  1  1/3123 (0.03%)  1
Gouty arthritis  1  1/3123 (0.03%)  1
Joint swelling  1  2/3123 (0.06%)  2
Limb discomfort  1  3/3123 (0.10%)  3
Muscle spasms  1  1/3123 (0.03%)  1
Musculoskeletal discomfort  1  1/3123 (0.03%)  1
Musculoskeletal disorder  1  2/3123 (0.06%)  2
Musculoskeletal pain  1  1/3123 (0.03%)  1
Neck pain  1  1/3123 (0.03%)  2
Osteochondrosis  1  2/3123 (0.06%)  2
Pain in extremity  1  9/3123 (0.29%)  10
Pain in jaw  1  4/3123 (0.13%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer  1  2/3123 (0.06%)  2
Gallbladder cancer  1  1/3123 (0.03%)  1
Neoplasm malignant  1  2/3123 (0.06%)  2
Throat cancer  1  1/3123 (0.03%)  1
Tongue neoplasm malignant stage unspecified  1  1/3123 (0.03%)  1
Nervous system disorders   
Brain injury  1  2/3123 (0.06%)  2
Cerebral haemorrhage  1  2/3123 (0.06%)  2
Cerebrovascular accident  1  17/3123 (0.54%)  22
Coma  1  1/3123 (0.03%)  1
Convulsion  1  3/3123 (0.10%)  3
Dementia  1  1/3123 (0.03%)  1
Diabetic coma  1  1/3123 (0.03%)  1
Dizziness  1  20/3123 (0.64%)  21
Dyskinesia  1  2/3123 (0.06%)  2
Embolic cerebral infarction  1  1/3123 (0.03%)  1
Epilepsy  1  1/3123 (0.03%)  1
Haemorrhagic stroke  1  1/3123 (0.03%)  1
Haemorrhagic transformation stroke  1  1/3123 (0.03%)  1
Headache  1  7/3123 (0.22%)  7
Hypoaesthesia  1  6/3123 (0.19%)  6
Intracranial aneurysm  1  1/3123 (0.03%)  1
Loss of consciousness  1  8/3123 (0.26%)  8
Migraine  1  1/3123 (0.03%)  1
Paraesthesia  1  2/3123 (0.06%)  2
Syncope  1  12/3123 (0.38%)  12
Thrombotic stroke  1  1/3123 (0.03%)  1
Transient ischaemic attack  1  5/3123 (0.16%)  5
Unresponsive to stimuli  1  1/3123 (0.03%)  1
Psychiatric disorders   
Alcohol withdrawal syndrome  1  1/3123 (0.03%)  1
Anxiety  1  7/3123 (0.22%)  7
Confusional state  1  1/3123 (0.03%)  1
Depression  1  3/3123 (0.10%)  3
Fear  1  1/3123 (0.03%)  1
Insomnia  1  1/3123 (0.03%)  1
Major depression  1  2/3123 (0.06%)  2
Mental disorder  1  1/3123 (0.03%)  1
Neurosis  1  1/3123 (0.03%)  1
Panic attack  1  1/3123 (0.03%)  1
Suicidal ideation  1  1/3123 (0.03%)  1
Suicide attempt  1  2/3123 (0.06%)  2
Renal and urinary disorders   
Calculus urinary  1  1/3123 (0.03%)  1
Haematuria  1  1/3123 (0.03%)  1
Nephrolithiasis  1  7/3123 (0.22%)  7
Renal failure  1  3/3123 (0.10%)  3
Renal failure acute  1  1/3123 (0.03%)  1
Renal failure chronic  1  1/3123 (0.03%)  1
Reproductive system and breast disorders   
Menorrhagia  1  1/672 (0.15%)  1
Ovarian cyst ruptured  1  1/672 (0.15%)  1
Prostatic haemorrhage  1  1/2451 (0.04%)  1
Testicular swelling  1  1/2451 (0.04%)  1
Vaginal haemorrhage  1  2/672 (0.30%)  2
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  2/3123 (0.06%)  2
Asthma  1  4/3123 (0.13%)  4
Bronchiectasis  1  1/3123 (0.03%)  1
Chronic obstructive pulmonary disease  1  3/3123 (0.10%)  3
Cough  1  2/3123 (0.06%)  2
Dyspnoea  1  38/3123 (1.22%)  59
Epistaxis  1  5/3123 (0.16%)  6
Haemoptysis  1  2/3123 (0.06%)  2
Hypoxia  1  1/3123 (0.03%)  1
Pleural effusion  1  7/3123 (0.22%)  7
Pleurisy  1  1/3123 (0.03%)  1
Pneumothorax  1  3/3123 (0.10%)  3
Pulmonary congestion  1  1/3123 (0.03%)  1
Pulmonary embolism  1  2/3123 (0.06%)  2
Pulmonary oedema  1  5/3123 (0.16%)  5
Wheezing  1  1/3123 (0.03%)  1
Skin and subcutaneous tissue disorders   
Erythema  1  1/3123 (0.03%)  1
Hyperhidrosis  1  5/3123 (0.16%)  5
Pruritus  1  1/3123 (0.03%)  1
Rash  1  2/3123 (0.06%)  2
Urticaria  1  2/3123 (0.06%)  2
Surgical and medical procedures   
Angioplasty  1  5/3123 (0.16%)  5
Antibiotic therapy  1  1/3123 (0.03%)  1
Appendicectomy  1  1/3123 (0.03%)  1
Bladder irrigation  1  1/3123 (0.03%)  2
Cardiac ablation  1  2/3123 (0.06%)  2
Cardiac operation  1  1/3123 (0.03%)  1
Cardiac pacemaker insertion  1  3/3123 (0.10%)  3
Cholecystostomy  1  1/3123 (0.03%)  1
Coronary arterial stent insertion  1  32/3123 (1.02%)  32
Coronary artery bypass  1  9/3123 (0.29%)  9
Coronary revascularisation  1  2/3123 (0.06%)  2
Dialysis  1  2/3123 (0.06%)  2
Emergency care  1  1/3123 (0.03%)  1
Exploratory operation  1  1/3123 (0.03%)  1
Hernia repair  1  1/3123 (0.03%)  1
Hospitalisation  1  9/3123 (0.29%)  9
Implantable defibrillator insertion  1  4/3123 (0.13%)  4
Medical device removal  1  1/3123 (0.03%)  1
Percutaneous coronary intervention  1  1/3123 (0.03%)  1
Stent placement  1  24/3123 (0.77%)  24
Surgery  1  2/3123 (0.06%)  3
Therapy change  1  1/3123 (0.03%)  2
Transfusion  1  1/3123 (0.03%)  1
Vascular cauterisation  1  1/3123 (0.03%)  1
Vascular disorders   
Arterial haemorrhage  1  1/3123 (0.03%)  1
Arterial occlusive disease  1  1/3123 (0.03%)  1
Arteriosclerosis  1  1/3123 (0.03%)  1
Haematoma  1  1/3123 (0.03%)  1
Haemorrhage  1  39/3123 (1.25%)  39
Hypertension  1  10/3123 (0.32%)  11
Hypotension  1  6/3123 (0.19%)  6
Neurogenic shock  1  1/3123 (0.03%)  1
Orthostatic hypotension  1  1/3123 (0.03%)  1
Peripheral artery aneurysm  1  2/3123 (0.06%)  2
Shock  1  1/3123 (0.03%)  1
Thrombosis  1  7/3123 (0.22%)  7
Vasculitis  1  1/3123 (0.03%)  1
Venous occlusion  1  1/3123 (0.03%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Prasugrel
Affected / at Risk (%) # Events
Total   0/3123 (0.00%)    
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01088503    
Other Study ID Numbers: 12549
H7T-US-B007 ( Other Identifier: Eli Lilly and Company )
First Submitted: March 15, 2010
First Posted: March 17, 2010
Results First Submitted: January 29, 2015
Results First Posted: January 29, 2016
Last Update Posted: January 29, 2016