NCT01611272已完成不适用
A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Brilinta
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 3,402
- 试验地点
- 1
- 主要终点
- Number of other AEs
研究概览
简要总结
To identify the following items through the post marketing surveillance under routine clinical practice after marketing authorization of Brilinta Tablet: the occurrence of unrevealed Serious Adverse Events (SAEs), current status of occurrence of Adverse Events (AEs), the factors that may influence safety and efficacy of the drug.
详细描述
A Post Marketing Surveillance to evaluate the safety and efficacy of Brilinta
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
- 19 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Acute Coronary Syndromes
- •Patients who are taking ticagrelor and ASA daily(75-150mg), or Patients who are taking ticagrelor only(In the case that the patients have contraindication with ASA. Contraindication should be recorded in accordance with local PI on CRFs)
- •Patients who have signed the Data release consent form prior to enrollment in this surveillance
排除标准
- •Patients with hypersensitivity to ingredients of this drug or with moderate or severe hepatic impairment or with medical history of intracranial hemorrhage
- •Patients with pathological hemorrhage at the time of administration
- •Patients being administrated strong CYP3A4 inhibitors
结局指标
主要结局
Number of other AEs
时间窗: up to 54 months
Number of Hemorrhage events
时间窗: up to 54 months
次要结局
- Number of Stroke events(up to 54 months)
- Number of Myocardial Infarction events(up to 54 months)
- Number of Cardiovascular (CV) related deaths events(up to 54 months)
研究者
研究点 (1)
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