Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-01 @ 1:43 PM
Study NCT ID:
NCT01088503
Status:
COMPLETED
Last Update Posted:
2016-01-29
First Post:
2010-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment With Adenosine Diphosphate (ADP) Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
The TRANSLATE-ACS Study: Treatment With ADP Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRANSLATE-ACS
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| H7T-US-B007 | OTHER | Eli Lilly and Company | View |