Treatment With Adenosine Diphosphate (ADP) Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS)
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.
|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|
- 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 ]
- 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 ]
|Study Start Date:||March 2010|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088503
Show 186 Study Locations
|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|