NCT03212287已完成不适用
Brilinta Tablets 60mg/90mg Clinical Experience Investigation
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
- 663
- 试验地点
- 1
- 主要终点
- Adverse event incidence
研究概览
简要总结
To confirm the following safety topics in patients to be treated with BRILINTA tablets 60 mg or 90 mg (hereinafter referred to as "BRILINTA") in clinical practice in the post-marketing phase.
- Profile and incidence of ADRs The CEI will be conducted to collect data of the events, especially focusing on bleeding, dyspnoea and bradyarrhythmia so as to investigate onset, outcome, treatment for the event, and risk factors for these events, etc.
- Profile and incidence of ADRs not expected from "Precautions for Use" of the ticagrelor JPI
- Efficacy: Profile and incidence of cardiovascular events (cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke)
- Factors which may affect safety or efficacy of ticagrelor
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 130 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated with BRILINTA for ACS or OMI, which is the indication of the drug.
排除标准
- 未提供
结局指标
主要结局
Adverse event incidence
时间窗: from baseline to 4 years
Incidence of ADRs not expected from "Precautions for Use" of the ticagrelor JPI
时间窗: from baseline to 4 years
Factors which may affect incidence of cardiovascular events, analysed by patient demographic characteristic and by treatment
时间窗: from baseline to 4 years
Incidence of cardiovascular events
时间窗: from baseline to 4 years
Factors which may affect incidence of bleeding, dyspnoea, bradyarrhythmia, analysed by patient demographic characteristic and by treatment
时间窗: from baseline to 4 years
次要结局
未报告次要终点
研究者
研究点 (1)
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