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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01088503
Collaborator
Daiichi Sankyo, Inc. (Industry)
12,227
Enrollment
186
Locations
46.1
Duration (Months)
65.7
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) study is a prospective, observational longitudinal study to evaluate the real world effectiveness and use of prasugrel and other ADP receptor inhibitor therapies among myocardial infarction (MI) participants treated with percutaneous coronary intervention (PCI) during the index hospitalization. Participant management and treatment decisions are at the discretion of the care team per routine clinical practice. Approximately 17,000 participants will be enrolled at approximately 350 sites in the United States. Follow-up will be conducted through 15 months in approximately 15,650 participants.

TRANSLATE-ACS will complement the results of both randomized controlled clinical trials and current registries in addressing the real world treatment patterns and clinical outcomes for MI participants managed with PCI and initiated on ADP receptor inhibitor therapy. In addition to determining the effectiveness of prasugrel in comparison to other ADP receptor inhibitors, the study will also determine factors associated with initial ADP receptor inhibitor selection and longitudinal patterns of use, evaluate the safety, and describe and compare resource use and medical costs associated with ADP receptor inhibitors. Additionally, this study will generate a continuum of information from the inpatient to outpatient settings to provide a comprehensive picture of participant treatment and outcomes not currently available for novel ADP receptor inhibitors.

Condition or Disease Intervention/Treatment Phase
  • Drug: ADP receptor inhibitors

Study Design

Study Type:
Observational
Actual Enrollment :
12227 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The TRANSLATE-ACS Study: Treatment With ADP Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

Arm Intervention/Treatment
ADP receptor inhibitor treatment

Participants admitted for non ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) and treated with an ADP receptor inhibitor during the index hospitalization.

Drug: ADP receptor inhibitors
Dosage regimen as determined by the treating physician.

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants With Major Adverse Cardiovascular Events (MACE) [Baseline through 12 months]

    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.

  2. Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment [Day 0 (study enrollment)]

    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.

  3. Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Pre-Procedure Hemoglobin [Day 0 (study enrollment)]

  4. Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Duke Coronary Artery Disease (CAD) Index [Day 0 (study enrollment)]

    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.

Secondary Outcome Measures

  1. Percentage of Participants With Cumulative Severe or Moderate Bleeding Events [Baseline, 1, 6, 12 and 15 months]

    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.

  2. 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 [Baseline through 12 months]

    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.

  3. Percentage of Participants With MACE Over 1, 6 and 15 Months [Baseline through 1, 6 and 15 months]

    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.

  4. Percentage of Participants With Definite or Probable Stent Thrombosis (ST) Events [Baseline through 15 months]

    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.

  5. Resource Use Patterns, Cumulative Total Medical Costs, and Cost Effectiveness [15 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • greater than or equal to 18 years of age

  • diagnosed with NSTEMI or STEMI treated with a PCI during the index hospitalization

  • initiated (or continued) on ADP receptor inhibitor therapy before discharge

  • fully informed and are able to provide written consent for longitudinal follow-up and data collection

Exclusion Criteria:
  • simultaneously participating in a research study that directs choice of either an investigational or approved ADP receptor inhibitor within the first 12 months after MI

Contacts and Locations

Locations

Site City State Country Postal Code
1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Birmingham Alabama United States 35233
2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Mobile Alabama United States 36617
3 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Anchorage Alaska United States 99508
4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fayetteville Alaska United States 72703
5 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gilbert Arizona United States 85297
6 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Scottsdale Arizona United States 85258
7 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tucson Arizona United States 85723
8 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fort Smith Arkansas United States 72901
9 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Little Rock Arkansas United States 72205
10 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rogers Arkansas United States 72758
11 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Berkeley California United States 94705
12 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Loma Linda California United States 92354
13 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Newport Beach California United States 92663
14 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Northridge California United States 91325
15 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Roseville California United States 95661
16 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sacramento California United States 95819
17 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Salinas California United States 93901
18 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Santa Barbara California United States 93105
19 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Stockton California United States 95204
20 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Thousand Oaks California United States 91360
21 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Torrance California United States 90505
22 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Aurora Colorado United States 80045
23 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Parker Colorado United States 80138
24 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bridgeport Connecticut United States 06610
25 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Danbury Connecticut United States 06810
26 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Farmington Connecticut United States 06030
27 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hartford Connecticut United States 06102
28 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Newark Delaware United States 19718
29 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Washington District of Columbia United States 20010
30 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Atlantis Florida United States 33462
31 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brandon Florida United States 33511
32 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ft Lauderdale Florida United States 33308
33 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gainesville Florida United States 32608
34 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hudson Florida United States 34667
35 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Jacksonville Florida United States 32209
36 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lakeland Florida United States 33805
37 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Melbourne Florida United States 32901
38 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Miami Beach Florida United States 33140
39 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ocala Florida United States 34471
40 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Orlando Florida United States 32806
41 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Stuart Florida United States 34996
42 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tampa Florida United States 33613
43 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vero Beach Florida United States 32960
44 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wellington Florida United States 33449
45 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Winter Haven Florida United States 33881
46 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Columbus Georgia United States 31904
47 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Marietta Georgia United States 30060
48 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Riverdale Georgia United States 30274
49 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Honolulu Hawaii United States 96813
50 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Carbondale Illinois United States 62901
51 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chicago Illinois United States 60625
52 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Geneva Illinois United States 60134
53 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hoffman Estates Illinois United States 60169
54 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Joliet Illinois United States 60435
55 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Oak Lawn Illinois United States 60453
56 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Peoria Illinois United States 61614
57 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rock Island Illinois United States 61201
58 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rockford Illinois United States 61107
59 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Urbana Illinois United States 61801
60 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Elkhart Indiana United States 46514
61 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ft Wayne Indiana United States 46805
62 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hammond Indiana United States 46320
63 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Indianapolis Indiana United States 46250
64 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lafayette Indiana United States 47905
65 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Muncie Indiana United States 47303
66 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Davenport Iowa United States 52803
67 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kansas City Kansas United States 66160
68 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Overland Park Kansas United States 66209
69 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Topeka Kansas United States 66604
70 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wichita Kansas United States 67220
71 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Crestview Hills Kentucky United States 41017
72 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lexington Kentucky United States 40504
73 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Owensboro Kentucky United States 42303
74 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Alexandria Louisiana United States 71301
75 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lewiston Maine United States 04240
76 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Annapolis Maryland United States 21401
77 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Baltimore Maryland United States 21215
78 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cumberland Maryland United States 21502
79 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hagerstown Maryland United States 21740
80 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Salisbury Maryland United States 21804
81 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Takoma Park Maryland United States 20912
82 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Worcester Massachusetts United States 01606
83 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ann Arbor Michigan United States 48109
84 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bay City Michigan United States 48708
85 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dearborn Michigan United States 48124
86 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Detroit Michigan United States 48202
87 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Flint Michigan United States 48532
88 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Grand Blanc Michigan United States 48439
89 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Marquette Michigan United States 49855
90 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Mount Clemens Michigan United States 48043
91 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saginaw Michigan United States 48602
92 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Southfield Michigan United States 48075
93 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. St. Joseph Michigan United States 49085
94 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Troy Michigan United States 48085
95 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Warren Michigan United States 48093
96 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wyoming Michigan United States 49519
97 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Coon Rapids Minnesota United States 55433
98 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Duluth Minnesota United States 55805
99 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Edina Minnesota United States 55435
100 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Minneapolis Minnesota United States 55455
101 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. St Cloud Minnesota United States 56303
102 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Columbia Missouri United States 65212
103 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Joplin Missouri United States 64804
104 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kansas City Missouri United States 64114
105 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. North Kansas City Missouri United States 64116
106 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Springfield Missouri United States 65804
107 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. St Louis Missouri United States 63141
108 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bozeman Montana United States 59715
109 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kalispell Montana United States 59901
110 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Omaha Nebraska United States 68198
111 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Las Vegas Nevada United States 89102
112 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Reno Nevada United States 89503
113 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nashua New Hampshire United States 03060
114 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bridgewater New Jersey United States 08807
115 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cherry Hill New Jersey United States 08034
116 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. New Brunswick New Jersey United States 08901
117 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Newark New Jersey United States 07055
118 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ridgewood New Jersey United States 07450
119 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Summit New Jersey United States 07902
120 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Albuquerque New Mexico United States 87131
121 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brooklyn New York United States 11215
122 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Elmira New York United States 14905
123 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Johnson City New York United States 13790
124 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. New York New York United States 10075
125 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Stony Brook New York United States 11794
126 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Utica New York United States 13501
127 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Valhalla New York United States 10595
128 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chapel Hill North Carolina United States 27599
129 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lumberton North Carolina United States 28358
130 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Raleigh North Carolina United States 27609
131 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wilmington North Carolina United States 28402
132 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Winston-Salem North Carolina United States 27157
133 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Canton Ohio United States 44710
134 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cincinnati Ohio United States 45267
135 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kettering Ohio United States 45429
136 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Middleburg Heights Ohio United States 44130
137 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Toledo Ohio United States 43615
138 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Youngstown Ohio United States 44501
139 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Oklahoma City Oklahoma United States 73112
140 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bend Oregon United States 97701
141 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Portland Oregon United States 97225
142 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tualatin Oregon United States 97062
143 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Abington Pennsylvania United States 19001
144 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Allentown Pennsylvania United States 18104
145 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bryn Mawr Pennsylvania United States 19010
146 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Camp Hill Pennsylvania United States 17011
147 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Danville Pennsylvania United States 17822
148 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Darby Pennsylvania United States 19023
149 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Greensburg Pennsylvania United States 15601
150 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Harrisburg Pennsylvania United States 17111
151 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hershey Pennsylvania United States 17033
152 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Johnstown Pennsylvania United States 15905
153 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lancaster Pennsylvania United States 17602
154 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Langhorne Pennsylvania United States 19047
155 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Philadelphia Pennsylvania United States 19140
156 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pittsburgh Pennsylvania United States 15240
157 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sayre Pennsylvania United States 18840
158 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Uniontown Pennsylvania United States 15401
159 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Anderson South Carolina United States 29621
160 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Charleston South Carolina United States 29485
161 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Columbia South Carolina United States 29203
162 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Memphis Tennessee United States 38120
163 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nashville Tennessee United States 37205
164 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dallas Texas United States 75216
165 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Decatur Texas United States 76234
166 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Grapevine Texas United States 76051
167 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Houston Texas United States 77030
168 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Round Rock Texas United States 78665
169 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Temple Texas United States 76508
170 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Charlottesville Virginia United States 22908
171 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chesapeake Virginia United States 23320
172 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Danville Virginia United States 24541
173 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Newport News Virginia United States 23601
174 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Norfolk Virginia United States 23507
175 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Richmond Virginia United States 23320
176 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Roanoke Virginia United States 24018
177 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Virginia Beach Virginia United States 23454
178 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Winchester Virginia United States 22601
179 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bellevue Washington United States 98004
180 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Everett Washington United States 98201
181 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Huntington West Virginia United States 25701
182 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Green Bay Wisconsin United States 54308
183 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Milwaukee Wisconsin United States 53215
184 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Racine Wisconsin United States 53405
185 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Waukesha Wisconsin United States 53188
186 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rio Piedras Puerto Rico 00924

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  • Eli Lilly and Company
  • Daiichi Sankyo, Inc.

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01088503
Other Study ID Numbers:
  • 12549
  • H7T-US-B007
First Posted:
Mar 17, 2010
Last Update Posted:
Jan 29, 2016
Last Verified:
Dec 1, 2015
Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail 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
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

Baseline Characteristics

Arm/Group Title Prasugrel Clopidogrel Ticlopidine/Ticagrelor Total
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 Participants 3123 8846 258 12227
Age, Customized (participants) [Number]
≥75 years
88
2.8%
1341
15.2%
33
12.8%
1462
12%
<75 years
3035
97.2%
7505
84.8%
225
87.2%
10765
88%
Sex: Female, Male (Count of 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) (Count of Participants)
Hispanic or Latino
129
4.1%
271
3.1%
13
5%
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) (Count of Participants)
American Indian or Alaska Native
35
1.1%
39
0.4%
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%
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%
Unknown or Not Reported
34
1.1%
102
1.2%
2
0.8%
138
1.1%
Region of Enrollment (participants) [Number]
United States
3123
100%
8846
100%
258
100%
12227
100%

Outcome Measures

1. Primary Outcome
Title Percentage of Participants With Major Adverse Cardiovascular Events (MACE)
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

Outcome Measure Data

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
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.
Measure Participants 3123 8838
Number (95% Confidence Interval) [percentage of participants]
13.14
0.4%
17.12
0.2%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
Comments
Type of Statistical Test Superiority or Other
Comments
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
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.88 to 1.22
Parameter Dispersion Type:
Value:
Estimation Comments
2. Primary Outcome
Title Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment
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)

Outcome Measure Data

Analysis Population Description
All enrolled participants
Arm/Group Title Prasugrel Other
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
Measure Participants 3123 9104
Received DES
2365
75.7%
6282
71%
Received only BMS
672
21.5%
2491
28.2%
STEMI
1831
58.6%
4508
51%
Other Race (Non-Caucasian)
365
11.7%
1049
11.9%
Cardiogenic Shock on Presentation
79
2.5%
176
2%
Male Participants
2451
78.5%
6342
71.7%
EQ-5D US index = 1 vs. <1
1516
48.5%
3873
43.8%
Married Participants
2044
65.4%
5601
63.3%
Participant has Diabetes
767
24.6%
2472
27.9%
No BMS or DES
86
2.8%
331
3.7%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.464
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments Odds Ratio for selection of Prasugrel for participants with DES vs BMS.
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.230
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments Odds Ratio for selection of Prasugrel for participants with STEMI vs not STEMI
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 1.657
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments Odds Ratio for selection of Prasugrel for participants who were Other Race vs Caucasian.
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 1.684
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments Odds Ratio for selection of Prasugrel for participants who had cardiogenic shock within 24 hours vs no cardiogenic shock within 24 hours.
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.195
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments Odds Ratio for selection of Prasugrel for participants who were male vs not male.
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.120
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments Odds Ratio for selection of Prasugrel for participants with EQ-5D US index = 1 vs. <1.
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.116
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments Odds Ratio for selection of Prasugrel for participants who were married vs not married.
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.125
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments Odds Ratio for selection of Prasugrel for participants who had diabetes vs no diabetes.
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.172
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments Odds Ratio for selection of Prasugrel for participants with no BMS or DES placement vs BMS.
3. Secondary Outcome
Title Percentage of Participants With Cumulative Severe or Moderate Bleeding Events
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

Outcome Measure Data

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
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.
Measure Participants 3123 8833
Baseline
0.54
0%
0.45
0%
1 month
1.22
0%
1.62
0%
6 months
1.93
0.1%
2.77
0%
12 months
2.72
0.1%
3.86
0%
15 months
3.10
0.1%
4.21
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
Comments
Type of Statistical Test Superiority or Other
Comments
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
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.30
Confidence Interval (2-Sided) 95%
0.88 to 1.93
Parameter Dispersion Type:
Value:
Estimation Comments Hazard ratio (HR) is for the analysis at 12 months.
4. 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
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

Outcome Measure Data

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
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.
Measure Participants 3123 8838
Number (95% Confidence Interval) [percentage of participants]
12.67
0.4%
15.89
0.2%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Clopidogrel
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.967
Confidence Interval (2-Sided) 95%
0.849 to 1.103
Parameter Dispersion Type:
Value:
Estimation Comments Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.
5. Secondary Outcome
Title Percentage of Participants With MACE Over 1, 6 and 15 Months
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

Outcome Measure Data

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
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.
Measure Participants 3123 8838
1 month
4.63
0.1%
5.40
0.1%
6 months
9.64
0.3%
12.04
0.1%
15 months
14.26
0.5%
19.13
0.2%
6. Secondary Outcome
Title Percentage of Participants With Definite or Probable Stent Thrombosis (ST) Events
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

Outcome Measure Data

Analysis Population Description
Participants who were treated with prasugrel or clopidogrel.
Arm/Group Title Prasugrel Clopidogrel
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.
Measure Participants 3123 8846
Number (95% Confidence Interval) [percentage of participants]
1.35
0%
1.79
0%
7. Secondary Outcome
Title Resource Use Patterns, Cumulative Total Medical Costs, and Cost Effectiveness
Description
Time Frame 15 months

Outcome Measure Data

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
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.
Measure Participants 0 0
8. Primary Outcome
Title Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Pre-Procedure Hemoglobin
Description
Time Frame Day 0 (study enrollment)

Outcome Measure Data

Analysis Population Description
All enrolled participants who had pre-procedure hemoglobin evaluation.
Arm/Group Title Prasugrel Other
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
Measure Participants 2806 8246
Mean (Standard Deviation) [grams/deciliter (g/dL)]
14.59
(1.702)
14
(1.909)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.050
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments Odds Ratio for selection of Prasugrel for participants who had pre-procedure hemoglobin evaluation vs no hemoglobin evaluation.
9. Primary Outcome
Title Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Duke Coronary Artery Disease (CAD) Index
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)

Outcome Measure Data

Analysis Population Description
All enrolled participants who had Duke CAD Index completed.
Arm/Group Title Prasugrel Other
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
Measure Participants 3101 8923
Mean (Standard Deviation) [units on a scale]
40.36
(14.43)
41.87
(16.01)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.005
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments Odds Ratio for selection of Prasugrel for participants with Duke CAD Index vs no Duke CAD Index.

Adverse Events

Time Frame
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
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 (%) # Events
Total / (NaN)
Serious Adverse Events
Prasugrel
Affected / at Risk (%) # Events
Total 865/3123 (27.7%)
Blood and lymphatic system disorders
Anaemia 4/3123 (0.1%) 4
Cardiac disorders
Acute coronary syndrome 1/3123 (0%) 1
Acute myocardial infarction 26/3123 (0.8%) 26
Angina pectoris 23/3123 (0.7%) 23
Angina unstable 24/3123 (0.8%) 25
Arrhythmia 7/3123 (0.2%) 7
Arteriosclerosis coronary artery 25/3123 (0.8%) 25
Atrial fibrillation 9/3123 (0.3%) 11
Atrial flutter 3/3123 (0.1%) 3
Atrioventricular block complete 1/3123 (0%) 1
Cardiac arrest 7/3123 (0.2%) 7
Cardiac disorder 3/3123 (0.1%) 3
Cardiac failure 3/3123 (0.1%) 3
Cardiac failure acute 7/3123 (0.2%) 7
Cardiac failure congestive 19/3123 (0.6%) 22
Cardiac flutter 1/3123 (0%) 1
Cardiomegaly 1/3123 (0%) 1
Cardiovascular disorder 2/3123 (0.1%) 2
Coronary artery disease 3/3123 (0.1%) 3
Coronary artery occlusion 6/3123 (0.2%) 6
Dressler's syndrome 3/3123 (0.1%) 3
Hypertensive heart disease 1/3123 (0%) 1
Mitral valve incompetence 1/3123 (0%) 1
Myocardial infarction 109/3123 (3.5%) 136
Myocardial ischaemia 1/3123 (0%) 1
Palpitations 7/3123 (0.2%) 8
Pericardial effusion 2/3123 (0.1%) 2
Pericarditis 2/3123 (0.1%) 2
Supraventricular tachycardia 1/3123 (0%) 1
Tachycardia 1/3123 (0%) 1
Ventricular fibrillation 1/3123 (0%) 1
Ventricular tachycardia 1/3123 (0%) 1
Ear and labyrinth disorders
Ear pain 1/3123 (0%) 1
Vertigo positional 1/3123 (0%) 1
Eye disorders
Amaurosis 1/3123 (0%) 1
Blindness 1/3123 (0%) 1
Vitreous floaters 1/3123 (0%) 1
Gastrointestinal disorders
Abdominal discomfort 4/3123 (0.1%) 4
Abdominal distension 1/3123 (0%) 1
Abdominal pain 7/3123 (0.2%) 7
Abdominal pain upper 7/3123 (0.2%) 7
Colitis 3/3123 (0.1%) 3
Constipation 1/3123 (0%) 1
Crohn's disease 1/3123 (0%) 1
Diarrhoea 2/3123 (0.1%) 2
Diverticulum 1/3123 (0%) 1
Dyspepsia 6/3123 (0.2%) 6
Epigastric discomfort 1/3123 (0%) 1
Faeces discoloured 2/3123 (0.1%) 2
Food poisoning 2/3123 (0.1%) 2
Gastric disorder 1/3123 (0%) 1
Gastric haemorrhage 3/3123 (0.1%) 3
Gastric ulcer 2/3123 (0.1%) 2
Gastric ulcer haemorrhage 1/3123 (0%) 1
Gastritis 3/3123 (0.1%) 4
Gastritis erosive 1/3123 (0%) 1
Gastroduodenitis 1/3123 (0%) 1
Gastrointestinal disorder 1/3123 (0%) 1
Gastrointestinal haemorrhage 8/3123 (0.3%) 9
Gastrointestinal inflammation 2/3123 (0.1%) 2
Gastrooesophageal reflux disease 3/3123 (0.1%) 4
Haematemesis 1/3123 (0%) 1
Haematochezia 3/3123 (0.1%) 4
Haemorrhoidal haemorrhage 1/3123 (0%) 1
Impaired gastric emptying 1/3123 (0%) 1
Intestinal obstruction 1/3123 (0%) 1
Intra-abdominal haemorrhage 1/3123 (0%) 1
Large intestinal haemorrhage 1/3123 (0%) 1
Large intestine polyp 1/3123 (0%) 1
Mallory-weiss syndrome 1/3123 (0%) 1
Melaena 1/3123 (0%) 1
Nausea 8/3123 (0.3%) 8
Oesophageal haemorrhage 2/3123 (0.1%) 2
Oesophageal rupture 2/3123 (0.1%) 2
Oesophageal spasm 1/3123 (0%) 1
Pancreatitis 2/3123 (0.1%) 2
Pancreatitis acute 1/3123 (0%) 1
Rectal haemorrhage 1/3123 (0%) 1
Small intestinal haemorrhage 1/3123 (0%) 1
Vomiting 10/3123 (0.3%) 10
General disorders
Adverse drug reaction 6/3123 (0.2%) 6
Arterial restenosis 1/3123 (0%) 1
Asthenia 3/3123 (0.1%) 4
Chest discomfort 12/3123 (0.4%) 12
Chest pain 247/3123 (7.9%) 309
Coronary artery restenosis 3/3123 (0.1%) 3
Death 50/3123 (1.6%) 53
Device damage 1/3123 (0%) 1
Device dislocation 1/3123 (0%) 1
Device failure 1/3123 (0%) 1
Device issue 1/3123 (0%) 1
Device malfunction 2/3123 (0.1%) 2
Device occlusion 6/3123 (0.2%) 6
Effusion 2/3123 (0.1%) 2
Fatigue 5/3123 (0.2%) 5
Feeling abnormal 1/3123 (0%) 1
Gait disturbance 1/3123 (0%) 1
Hyperthermia 1/3123 (0%) 1
Inflammation 1/3123 (0%) 1
Malaise 3/3123 (0.1%) 4
Non-cardiac chest pain 7/3123 (0.2%) 8
Oedema 2/3123 (0.1%) 2
Pain 2/3123 (0.1%) 2
Peripheral swelling 3/3123 (0.1%) 5
Pyrexia 2/3123 (0.1%) 2
Stent malfunction 4/3123 (0.1%) 4
Swelling 1/3123 (0%) 1
Systemic inflammatory response syndrome 1/3123 (0%) 1
Thrombosis in device 9/3123 (0.3%) 9
Ulcer haemorrhage 7/3123 (0.2%) 7
Unevaluable event 3/3123 (0.1%) 3
Vessel puncture site haemorrhage 1/3123 (0%) 1
Hepatobiliary disorders
Cholelithiasis 1/3123 (0%) 1
Gallbladder disorder 1/3123 (0%) 1
Gallbladder pain 1/3123 (0%) 1
Immune system disorders
Drug hypersensitivity 8/3123 (0.3%) 8
Infections and infestations
Abscess 1/3123 (0%) 1
Abscess limb 1/3123 (0%) 1
Appendicitis perforated 1/3123 (0%) 1
Bacterial infection 1/3123 (0%) 1
Bronchitis 7/3123 (0.2%) 7
Cellulitis 3/3123 (0.1%) 3
Clostridium difficile colitis 1/3123 (0%) 2
Clostridium difficile infection 1/3123 (0%) 1
Cystitis 3/3123 (0.1%) 3
Device related infection 1/3123 (0%) 1
Diverticulitis 1/3123 (0%) 1
Ear infection 1/3123 (0%) 1
Escherichia infection 2/3123 (0.1%) 2
Gastroenteritis 1/3123 (0%) 1
Gastrointestinal infection 1/3123 (0%) 1
Groin infection 2/3123 (0.1%) 2
Herpes zoster 1/3123 (0%) 2
Infection 4/3123 (0.1%) 4
Infective exacerbation of chronic obstructive airways disease 1/3123 (0%) 1
Influenza 2/3123 (0.1%) 2
Kidney infection 4/3123 (0.1%) 4
Localised infection 2/3123 (0.1%) 2
Meningitis 1/3123 (0%) 1
Orchitis 2/3123 (0.1%) 2
Pneumonia 21/3123 (0.7%) 22
Sepsis 3/3123 (0.1%) 3
Septic shock 1/3123 (0%) 1
Sinusitis 1/3123 (0%) 1
Staphylococcal infection 1/3123 (0%) 1
Urinary tract infection 3/3123 (0.1%) 3
Viral infection 1/3123 (0%) 1
Injury, poisoning and procedural complications
Abdominal injury 1/3123 (0%) 1
Ankle fracture 1/3123 (0%) 1
Chest injury 1/3123 (0%) 1
Contrast media reaction 1/3123 (0%) 1
Fall 10/3123 (0.3%) 10
Femur fracture 1/3123 (0%) 1
Fractured coccyx 1/3123 (0%) 1
Gastrointestinal injury 1/3123 (0%) 1
Head injury 6/3123 (0.2%) 6
Humerus fracture 1/3123 (0%) 1
Incision site haemorrhage 1/3123 (0%) 1
Injury 1/3123 (0%) 1
Intentional overdose 1/3123 (0%) 1
Joint injury 1/3123 (0%) 1
Limb injury 1/3123 (0%) 1
Limb traumatic amputation 1/3123 (0%) 1
Muscle strain 4/3123 (0.1%) 4
Overdose 2/3123 (0.1%) 3
Post procedural complication 1/3123 (0%) 1
Post procedural haematoma 1/3123 (0%) 1
Procedural complication 1/3123 (0%) 1
Rib fracture 3/3123 (0.1%) 3
Road traffic accident 5/3123 (0.2%) 5
Spinal fracture 1/3123 (0%) 1
Subdural haematoma 1/3123 (0%) 1
Thermal burn 1/3123 (0%) 1
Traumatic haematoma 1/3123 (0%) 1
Vascular pseudoaneurysm 4/3123 (0.1%) 5
Investigations
Angiogram 1/3123 (0%) 1
Aspiration pleural cavity 1/3123 (0%) 1
Barium enema 1/3123 (0%) 1
Biopsy lung 1/3123 (0%) 1
Blood glucose abnormal 2/3123 (0.1%) 3
Blood glucose decreased 2/3123 (0.1%) 2
Blood glucose fluctuation 1/3123 (0%) 1
Blood glucose increased 3/3123 (0.1%) 3
Blood potassium decreased 2/3123 (0.1%) 2
Blood potassium increased 1/3123 (0%) 1
Blood pressure decreased 4/3123 (0.1%) 4
Blood pressure increased 6/3123 (0.2%) 6
Blood triglycerides increased 1/3123 (0%) 1
Blood urine present 2/3123 (0.1%) 2
Cardiac stress test 2/3123 (0.1%) 2
Catheterisation cardiac 81/3123 (2.6%) 87
Colonoscopy 3/3123 (0.1%) 3
Computerised tomogram 1/3123 (0%) 1
Electrocardiogram 1/3123 (0%) 1
Electrocardiogram abnormal 3/3123 (0.1%) 3
Endoscopy 1/3123 (0%) 1
Enzyme level increased 1/3123 (0%) 1
Haemoglobin decreased 3/3123 (0.1%) 3
Haemoglobin increased 1/3123 (0%) 1
Heart rate abnormal 1/3123 (0%) 1
Heart rate decreased 2/3123 (0.1%) 2
Heart rate increased 4/3123 (0.1%) 4
Heart rate irregular 2/3123 (0.1%) 2
Imaging procedure 1/3123 (0%) 1
International normalised ratio increased 1/3123 (0%) 1
Oesophagogastroduodenoscopy 1/3123 (0%) 1
Metabolism and nutrition disorders
Dehydration 9/3123 (0.3%) 9
Diabetes mellitus 4/3123 (0.1%) 5
Diabetic complication 2/3123 (0.1%) 2
Diabetic ketoacidosis 1/3123 (0%) 2
Electrolyte imbalance 1/3123 (0%) 1
Fluid retention 3/3123 (0.1%) 3
Gout 1/3123 (0%) 1
Musculoskeletal and connective tissue disorders
Arthralgia 3/3123 (0.1%) 3
Arthropathy 1/3123 (0%) 1
Back disorder 1/3123 (0%) 1
Back pain 5/3123 (0.2%) 5
Bursitis 1/3123 (0%) 1
Gouty arthritis 1/3123 (0%) 1
Joint swelling 2/3123 (0.1%) 2
Limb discomfort 3/3123 (0.1%) 3
Muscle spasms 1/3123 (0%) 1
Musculoskeletal discomfort 1/3123 (0%) 1
Musculoskeletal disorder 2/3123 (0.1%) 2
Musculoskeletal pain 1/3123 (0%) 1
Neck pain 1/3123 (0%) 2
Osteochondrosis 2/3123 (0.1%) 2
Pain in extremity 9/3123 (0.3%) 10
Pain in jaw 4/3123 (0.1%) 4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer 2/3123 (0.1%) 2
Gallbladder cancer 1/3123 (0%) 1
Neoplasm malignant 2/3123 (0.1%) 2
Throat cancer 1/3123 (0%) 1
Tongue neoplasm malignant stage unspecified 1/3123 (0%) 1
Nervous system disorders
Brain injury 2/3123 (0.1%) 2
Cerebral haemorrhage 2/3123 (0.1%) 2
Cerebrovascular accident 17/3123 (0.5%) 22
Coma 1/3123 (0%) 1
Convulsion 3/3123 (0.1%) 3
Dementia 1/3123 (0%) 1
Diabetic coma 1/3123 (0%) 1
Dizziness 20/3123 (0.6%) 21
Dyskinesia 2/3123 (0.1%) 2
Embolic cerebral infarction 1/3123 (0%) 1
Epilepsy 1/3123 (0%) 1
Haemorrhagic stroke 1/3123 (0%) 1
Haemorrhagic transformation stroke 1/3123 (0%) 1
Headache 7/3123 (0.2%) 7
Hypoaesthesia 6/3123 (0.2%) 6
Intracranial aneurysm 1/3123 (0%) 1
Loss of consciousness 8/3123 (0.3%) 8
Migraine 1/3123 (0%) 1
Paraesthesia 2/3123 (0.1%) 2
Syncope 12/3123 (0.4%) 12
Thrombotic stroke 1/3123 (0%) 1
Transient ischaemic attack 5/3123 (0.2%) 5
Unresponsive to stimuli 1/3123 (0%) 1
Psychiatric disorders
Alcohol withdrawal syndrome 1/3123 (0%) 1
Anxiety 7/3123 (0.2%) 7
Confusional state 1/3123 (0%) 1
Depression 3/3123 (0.1%) 3
Fear 1/3123 (0%) 1
Insomnia 1/3123 (0%) 1
Major depression 2/3123 (0.1%) 2
Mental disorder 1/3123 (0%) 1
Neurosis 1/3123 (0%) 1
Panic attack 1/3123 (0%) 1
Suicidal ideation 1/3123 (0%) 1
Suicide attempt 2/3123 (0.1%) 2
Renal and urinary disorders
Calculus urinary 1/3123 (0%) 1
Haematuria 1/3123 (0%) 1
Nephrolithiasis 7/3123 (0.2%) 7
Renal failure 3/3123 (0.1%) 3
Renal failure acute 1/3123 (0%) 1
Renal failure chronic 1/3123 (0%) 1
Reproductive system and breast disorders
Menorrhagia 1/672 (0.1%) 1
Ovarian cyst ruptured 1/672 (0.1%) 1
Prostatic haemorrhage 1/2451 (0%) 1
Testicular swelling 1/2451 (0%) 1
Vaginal haemorrhage 2/672 (0.3%) 2
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure 2/3123 (0.1%) 2
Asthma 4/3123 (0.1%) 4
Bronchiectasis 1/3123 (0%) 1
Chronic obstructive pulmonary disease 3/3123 (0.1%) 3
Cough 2/3123 (0.1%) 2
Dyspnoea 38/3123 (1.2%) 59
Epistaxis 5/3123 (0.2%) 6
Haemoptysis 2/3123 (0.1%) 2
Hypoxia 1/3123 (0%) 1
Pleural effusion 7/3123 (0.2%) 7
Pleurisy 1/3123 (0%) 1
Pneumothorax 3/3123 (0.1%) 3
Pulmonary congestion 1/3123 (0%) 1
Pulmonary embolism 2/3123 (0.1%) 2
Pulmonary oedema 5/3123 (0.2%) 5
Wheezing 1/3123 (0%) 1
Skin and subcutaneous tissue disorders
Erythema 1/3123 (0%) 1
Hyperhidrosis 5/3123 (0.2%) 5
Pruritus 1/3123 (0%) 1
Rash 2/3123 (0.1%) 2
Urticaria 2/3123 (0.1%) 2
Surgical and medical procedures
Angioplasty 5/3123 (0.2%) 5
Antibiotic therapy 1/3123 (0%) 1
Appendicectomy 1/3123 (0%) 1
Bladder irrigation 1/3123 (0%) 2
Cardiac ablation 2/3123 (0.1%) 2
Cardiac operation 1/3123 (0%) 1
Cardiac pacemaker insertion 3/3123 (0.1%) 3
Cholecystostomy 1/3123 (0%) 1
Coronary arterial stent insertion 32/3123 (1%) 32
Coronary artery bypass 9/3123 (0.3%) 9
Coronary revascularisation 2/3123 (0.1%) 2
Dialysis 2/3123 (0.1%) 2
Emergency care 1/3123 (0%) 1
Exploratory operation 1/3123 (0%) 1
Hernia repair 1/3123 (0%) 1
Hospitalisation 9/3123 (0.3%) 9
Implantable defibrillator insertion 4/3123 (0.1%) 4
Medical device removal 1/3123 (0%) 1
Percutaneous coronary intervention 1/3123 (0%) 1
Stent placement 24/3123 (0.8%) 24
Surgery 2/3123 (0.1%) 3
Therapy change 1/3123 (0%) 2
Transfusion 1/3123 (0%) 1
Vascular cauterisation 1/3123 (0%) 1
Vascular disorders
Arterial haemorrhage 1/3123 (0%) 1
Arterial occlusive disease 1/3123 (0%) 1
Arteriosclerosis 1/3123 (0%) 1
Haematoma 1/3123 (0%) 1
Haemorrhage 39/3123 (1.2%) 39
Hypertension 10/3123 (0.3%) 11
Hypotension 6/3123 (0.2%) 6
Neurogenic shock 1/3123 (0%) 1
Orthostatic hypotension 1/3123 (0%) 1
Peripheral artery aneurysm 2/3123 (0.1%) 2
Shock 1/3123 (0%) 1
Thrombosis 7/3123 (0.2%) 7
Vasculitis 1/3123 (0%) 1
Venous occlusion 1/3123 (0%) 1
Other (Not Including Serious) Adverse Events
Prasugrel
Affected / at Risk (%) # Events
Total 0/3123 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title Chief Medical Officer
Organization Eli Lilly and Company
Phone 800-545-5979
Email
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01088503
Other Study ID Numbers:
  • 12549
  • H7T-US-B007
First Posted:
Mar 17, 2010
Last Update Posted:
Jan 29, 2016
Last Verified:
Dec 1, 2015