NCT01011504已完成不适用
A Registry Study to Determine Utilisation Patterns in Patients Receiving Angiox®, and Collect Descriptive Safety and Outcome Data to Inform the Risk Management Strategy for Europe.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,019
- 试验地点
- 2
- 主要终点
- Posology and usage patterns of Angiox®: Dose(s) and time of bolus and infusion administered
研究概览
简要总结
The objective of this study is to determine utilisation patterns in patients receiving Angiox® in participating European centres. Additionally, through the collection of descriptive safety and outcomes data, this study will contribute to the Risk Management strategy for Europe
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for, and receive treatment with Angiox®.
- •Willing and able to provide written informed consent to the use of their data in accordance with relevant local Data Protection laws, policies and regulations
排除标准
- •Participation in other interventional clinical research studies involving the evaluation of investigational drugs, including Angiox®, or devices at the time of enrolment.
- •Patients not eligible for treatment for Angiox®.
结局指标
主要结局
Posology and usage patterns of Angiox®: Dose(s) and time of bolus and infusion administered
时间窗: from hospital admission until hospital discharge, or 7 days after administration (which ever is earlier).
次要结局
- Death Myocardial infarction Unplanned revascularisation Stroke Major* and minor bleeding Thrombocytopenia Stent thrombosis Adverse events and serious adverse events(measured in-hospital (prior to discharge), and at post-hospital discharge in outpatient as per local practice (30 days))
研究者
研究点 (2)
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