The TRANSLATE-ACS Study: Treatment With ADP Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12,227
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: ADP receptor inhibitors (Drug)
结局指标
主要结局
Percentage of Participants With Major Adverse Cardiovascular Events (MACE)
时间窗: 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.
Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment
时间窗: 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.
Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Pre-Procedure Hemoglobin
时间窗: Day 0 (study enrollment)
Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Duke Coronary Artery Disease (CAD) Index
时间窗: 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.
次要结局
- Percentage of Participants With MACE Over 1, 6 and 15 Months(Baseline through 1, 6 and 15 months)
- 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)
- Percentage of Participants With Definite or Probable Stent Thrombosis (ST) Events(Baseline through 15 months)
- Percentage of Participants With Cumulative Severe or Moderate Bleeding Events(Baseline, 1, 6, 12 and 15 months)
- Resource Use Patterns, Cumulative Total Medical Costs, and Cost Effectiveness(15 months)