Treatment With Adenosine Diphosphate (ADP) Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS)
This study is ongoing, but not recruiting participants.
Sponsor:
Eli Lilly and Company
Collaborator:
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01088503
First received: March 15, 2010
Last updated: April 5, 2013
Last verified: April 2013
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Purpose
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) patients treated with percutaneous coronary intervention (PCI) during the index hospitalization. Patient management and treatment decisions are at the discretion of the care team per routine clinical practice. Approximately 17,000 patients will be enrolled at approximately 350 sites in the United States. Follow-up will be conducted through 15 months in approximately 15,650 patients.
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 patients 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 patient treatment and outcomes not currently available for novel ADP receptor inhibitors.
| Condition | Intervention |
|---|---|
|
Acute Coronary Syndrome |
Drug: ADP receptor inhibitors |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Major adverse cardiovascular events (MACE) [ Time Frame: 12 months ] [ Designated as safety issue: No ]MACE is defined as a composite of all-cause death, myocardial infarction (MI), stroke, or unplanned coronary revascularization
- Factors associated with initial ADP receptor inhibitor selection at enrollment and longitudinal patterns of use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Bleeding outcomes [ Time Frame: Index hospitalization, 1, 6, 12, 15 months ] [ Designated as safety issue: Yes ]
- MACE and bleeding outcomes in patients who have no prior history of transient ischemic attack (TIA)/stroke, weigh ≥60 kg, and are age <75 years old [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- MACE [ Time Frame: Index hospitalization, 1, 6, 15 months ] [ Designated as safety issue: No ]
- Stent thrombosis [ Time Frame: 15 months ] [ Designated as safety issue: No ]
- Resource use patterns, cumulative total medical costs, and cost effectiveness [ Time Frame: 15 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 17350 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
ADP receptor inhibitor treatment
Patients 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients admitted or already in hospital with acute myocardial infarction (MI) who are treated with percutaneous coronary intervention (PCI) and an ADP receptor inhibitor.
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088503
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| Cumberland, Maryland, United States, 21502 | |
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| Hagerstown, Maryland, United States, 21740 | |
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| Salisbury, Maryland, United States, 21804 | |
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| Takoma Park, Maryland, United States, 20912 | |
| United States, Massachusetts | |
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| Worcester, Massachusetts, United States, 01606 | |
| United States, Michigan | |
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| Ann Arbor, Michigan, United States, 48109 | |
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| Bay City, Michigan, United States, 48708 | |
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| Dearborn, Michigan, United States, 48124 | |
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| Detroit, Michigan, United States, 48202 | |
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| Flint, Michigan, United States, 48532 | |
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| Grand Blanc, Michigan, United States, 48439 | |
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| Marquette, Michigan, United States, 49855 | |
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| Mount Clemens, Michigan, United States, 48043 | |
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| Saginaw, Michigan, United States, 48602 | |
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| Southfield, Michigan, United States, 48075 | |
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| St. Joseph, Michigan, United States, 49085 | |
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| Troy, Michigan, United States, 48085 | |
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| Warren, Michigan, United States, 48093 | |
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| Wyoming, Michigan, United States, 49519 | |
| United States, Minnesota | |
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| Coon Rapids, Minnesota, United States, 55433 | |
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| Duluth, Minnesota, United States, 55805 | |
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| Edina, Minnesota, United States, 55435 | |
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| Minneapolis, Minnesota, United States, 55455 | |
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| St Cloud, Minnesota, United States, 56303 | |
| United States, Missouri | |
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| Columbia, Missouri, United States, 65212 | |
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| Joplin, Missouri, United States, 64804 | |
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| Kansas City, Missouri, United States, 64114 | |
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| North Kansas City, Missouri, United States, 64116 | |
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| Springfield, Missouri, United States, 65804 | |
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| St Louis, Missouri, United States, 63141 | |
| United States, Montana | |
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| Bozeman, Montana, United States, 59715 | |
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| Kalispell, Montana, United States, 59901 | |
| United States, Nebraska | |
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| Omaha, Nebraska, United States, 68198 | |
| United States, Nevada | |
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| Las Vegas, Nevada, United States, 89102 | |
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| Reno, Nevada, United States, 89503 | |
| United States, New Hampshire | |
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| Nashua, New Hampshire, United States, 03060 | |
| United States, New Jersey | |
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| Bridgewater, New Jersey, United States, 08807 | |
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| Cherry Hill, New Jersey, United States, 08034 | |
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| New Brunswick, New Jersey, United States, 08901 | |
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| Newark, New Jersey, United States, 07055 | |
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| Ridgewood, New Jersey, United States, 07450 | |
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| Summit, New Jersey, United States, 07902 | |
| United States, New Mexico | |
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| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
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| Brooklyn, New York, United States, 11215 | |
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| Elmira, New York, United States, 14905 | |
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| Johnson City, New York, United States, 13790 | |
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| New York, New York, United States, 10075 | |
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| Stony Brook, New York, United States, 11794 | |
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| Utica, New York, United States, 13501 | |
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| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
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| Chapel Hill, North Carolina, United States, 27599 | |
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| Lumberton, North Carolina, United States, 28358 | |
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| Raleigh, North Carolina, United States, 27609 | |
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| Wilmington, North Carolina, United States, 28402 | |
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| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
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| Canton, Ohio, United States, 44710 | |
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| Cincinnati, Ohio, United States, 45267 | |
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| Kettering, Ohio, United States, 45429 | |
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| Middleburg Heights, Ohio, United States, 44130 | |
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| Toledo, Ohio, United States, 43615 | |
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| Youngstown, Ohio, United States, 44501 | |
| United States, Oklahoma | |
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| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Oregon | |
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| Bend, Oregon, United States, 97701 | |
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| Portland, Oregon, United States, 97225 | |
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| Tualatin, Oregon, United States, 97062 | |
| United States, Pennsylvania | |
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| Abington, Pennsylvania, United States, 19001 | |
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| Allentown, Pennsylvania, United States, 18104 | |
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| Bryn Mawr, Pennsylvania, United States, 19010 | |
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| Camp Hill, Pennsylvania, United States, 17011 | |
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| Danville, Pennsylvania, United States, 17822 | |
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| Darby, Pennsylvania, United States, 19023 | |
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| Greensburg, Pennsylvania, United States, 15601 | |
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| Harrisburg, Pennsylvania, United States, 17111 | |
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| Hershey, Pennsylvania, United States, 17033 | |
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| Johnstown, Pennsylvania, United States, 15905 | |
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| Lancaster, Pennsylvania, United States, 17602 | |
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| Langhorne, Pennsylvania, United States, 19047 | |
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| Philadelphia, Pennsylvania, United States, 19140 | |
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| Pittsburgh, Pennsylvania, United States, 15240 | |
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| Sayre, Pennsylvania, United States, 18840 | |
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| Uniontown, Pennsylvania, United States, 15401 | |
| United States, South Carolina | |
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| Anderson, South Carolina, United States, 29621 | |
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| Charleston, South Carolina, United States, 29485 | |
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| Columbia, South Carolina, United States, 29203 | |
| United States, Tennessee | |
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| Memphis, Tennessee, United States, 38120 | |
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| Nashville, Tennessee, United States, 37205 | |
| United States, Texas | |
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| Dallas, Texas, United States, 75216 | |
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| Decatur, Texas, United States, 76234 | |
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| Grapevine, Texas, United States, 76051 | |
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| Houston, Texas, United States, 77030 | |
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| Round Rock, Texas, United States, 78665 | |
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| Temple, Texas, United States, 76508 | |
| United States, Virginia | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| United States, Washington | |
| 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 | |
| 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 | |
| United States, West Virginia | |
| 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 | |
| United States, Wisconsin | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| Puerto Rico | |
| 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 | |
Sponsors and Collaborators
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 |
More Information
No publications provided by Eli Lilly and Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01088503 History of Changes |
| Other Study ID Numbers: | 12549, H7T-US-B007 |
| Study First Received: | March 15, 2010 |
| Last Updated: | April 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris |
Vascular Diseases Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013