N/A
N=12,227
Treatment With Adenosine Diphosphate (ADP) Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome
Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01088503 ↗Enrolled (actual)
12,227
Serious AEs
27.7%
Results posted
Jan 2016
Primary outcome: Primary: Percentage of Participants With Major Adverse Cardiovascular Events (MACE) — 13.14; 17.12 percentage of participants — p=0.7108
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- ADP receptor inhibitors (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Major Adverse Cardiovascular Events (MACE) |
13.14; 17.12 | 0.7108 |
| PRIMARY Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment |
2365; 6282; 672; 2491; 1831; 4508 | — |
| PRIMARY Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Pre-Procedure Hemoglobin |
14.59; 14 | — |
| PRIMARY Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Duke Coronary Artery Disease (CAD) Index |
40.36; 41.87 | — |
| SECONDARY Percentage of Participants With Cumulative Severe or Moderate Bleeding Events |
0.54; 0.45; 1.22; 1.62; 1.93; 2.77 | 0.1882 |
| SECONDARY 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 |
12.67; 15.89 | — |
| SECONDARY Percentage of Participants With MACE Over 1, 6 and 15 Months |
4.63; 5.40; 9.64; 12.04; 14.26; 19.13 | — |
| SECONDARY Percentage of Participants With Definite or Probable Stent Thrombosis (ST) Events |
1.35; 1.79 | — |
| SECONDARY Resource Use Patterns, Cumulative Total Medical Costs, and Cost Effectiveness |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01088503). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.