TAXUS Libertē Post Approval Study: A U.S. Post-Approval Study of the TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,199
- 试验地点
- 82
- 主要终点
- Cardiac Death or Myocardial Infarction
研究概览
简要总结
The TAXUS Libertē Post-Approval Study is an FDA-mandated prospective, multi-center study designed to collect real-world safety and clinical outcomes in approximately 4,200 patients receiving one or more TAXUS Liberté Paclitaxel-Eluting Stents and prasugrel as part of a dual antiplatelet therapy (DAPT) drug regimen.
This study will also contribute patient data to an FDA-requested and industry-sponsored research study that will evaluate the optimal duration of dual antiplatelet therapy (DAPT Study).
详细描述
The TAXUS Libertē Post-Approval Study is an FDA-mandated prospective, multi-center study designed to collect real-world safety and clinical outcomes in approximately 4,200 patients receiving one or more TAXUS Liberté Paclitaxel-Eluting Stents and prasugrel as part of a dual antiplatelet therapy (DAPT) drug regimen. This is a consecutively-enrolled study with patient follow-up through 3 years post index procedure. This study also will contribute patient data to an FDA-requested and industry-sponsored research study that will evaluate the optimal duration of dual antiplatelet therapy (DAPT Study). To facilitate this patient data contribution, patients will be assigned to patient groups based upon their co-morbidities and stented lesions identified post index procedure.
All enrolled patients who have been treated with the TAXUS Liberté Stent will be assigned to 12 months of open-label prasugrel treatment and aspirin. Upon completion of the open-label period, patients who are clear of events at 12 months post index procedure will be randomized 1:1 to either a placebo or prasugrel for an additional 18 months of treatment. All patients will receive aspirin therapy throughout the course of the study.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Cardiac Death or Myocardial Infarction
时间窗: 12 months
Cardiac death or myocardial infarction in the TAXUS Liberte Post-Approval Study enrolled population. For pooled data from the TAXUS Liberté and TAXUS Express patient populations, please see the citations.
次要结局
- Incremental Rate of Stent Thrombosis (Protocol Definition)(1-2 years)
- Rate of Major Adverse Cardiac Events (MACE)(12 months)
- Rate of Stent Thrombosis (ARC Definite + Probable)(12 months)
- Target Vessel Failure (TVF) for the Medically-Treated Diabetic Population(12 months)
- Rate of Major Adverse Cardiac & Cerebrovascular Events (MACCE): Study Stent Related(6 months)
- Rate of Cardiac Death(12 months)
- Rate of Myocardial Infarction (MI)(12 months)
- Rate of Myocardial Infarction (MI): Study Stent Related(12 months)
- Rate of Target Vessel Reintervention (TVR): Study Stent Related(12 months)
- Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE): Study Stent Related(12 months)
- Rate of Major Adverse Cardiac Events (MACE): Study Stent Related(12 months)
- Rate of Target Vessel Failure (TVF)(12 months)
- Rate of Target Vessel Reintervention (TVR)(12 months)
- Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)(12 months)
- Rate of All Cause Death(12 months)
- Rate of Stroke(12 months)
- Rate of Major Bleeding(12 months)
- Rate of Cardiac Death or Myocardial Infarction (MI)(12 months)
- Rate of Cardiac Death: Study Stent Related(12 months)
- Rate of Stent Thrombosis (Protocol Definition)(12 months)