A Multicenter, Single Arm, Open Label, Phase IV Study to Evaluate Safety and to Describe the Cumulative Incidence of Major Cardiovascular Events of Ticagrelor in Taiwanese Patients With Non ST-segment Elevation Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Number of Participants With Bleeding Events (Major Bleedings)
研究概览
简要总结
A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the cumulative incidence of major cardiovascular events of Ticagrelor in Taiwanese patients with non ST-segment (a segment in the eletrocardiogram which presents the period when ventricles are depolarized) elevation myocardial infarction
详细描述
This study will be conducted in approximately 8 investigational centres in Taiwan. It is expected that approximately 100 patients will be enrolled into study treatment. This study is to describe the safety and tolerability of ticagrelor, by assessment of the bleeding events and other serious adverse events (SAEs) during 1year follow up in Taiwanese non ST-elevation myocardial infarction (NSTEMI) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Female or male aged at least 20 years
- •Patient who is considered as ethnic Taiwanese
- •Index event of non-ST elevation myocardial infarction
排除标准
- •Contraindication or other reason that ticagrelor should not be administered
- •Index event is an acute complication of Percutaneous coronary intervention (PCI)
- •Patient has planned for an urgent coronary artery bypass graft (CABG) within 7 days from the enrolment
- •Oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped
- •Fibrinolytic therapy in the 24 hours prior to enrolment, or planned fibrinolytic treatment following enrolment
研究组 & 干预措施
single arm
Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
干预措施: Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd) (Drug)
结局指标
主要结局
Number of Participants With Bleeding Events (Major Bleedings)
时间窗: during 1year follow up with ticagrelor treatment
Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major bleedings
Number of Participants With Fatal/Life-threatening Bleedings
时间窗: during 1year follow up with ticagrelor treatment
Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined fatal/life-threatening bleedings
Number of Participants With Bleeding Events (Major and Minor Bleedings)
时间窗: during 1year follow up with ticagrelor treatment
Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major + minor bleedings
Number of Participants With Other Serious Adverse Event (SAEs)
时间窗: during 1year follow up with ticagrelor treatment
Evaluation of serious adverse events other than bleedings
Number of Participants With Major Cardiovascular Events
时间窗: during 1year follow up with ticagrelor treatment
Evaluation of major cardiovascular events including cardiovascular death, myocardial infarction or stroke
次要结局
未报告次要终点