NCT02094963已完成4 期
A Randomized, Open-label, Parallel Group, Multicenter Phase IV Study to Assess Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients With Acute Coronary Syndromes Intended for Invasive Management:TICAKOREA Trial
Seung-Jung Park10 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2014年7月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 10
- 主要终点
- The time to first occurrence of any bleeding event
研究概览
简要总结
The purpose of this study is to assess safety and efficacy of Ticagrelor versus Clopidogrel in Asian/KOREAn patients with acute coronary syndromes intended for invasive management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age 18 and more
- •Index event of non-ST or ST segment elevation ACS
- •Provision of signed informed consent
排除标准
- •Hypersensitivity to aspirin or ticagrelor
- •Oral anticoagulation therapy that cannot be stopped
- •Treated with thrombolysis within 24hrs
- •Any other reason the investigator deems the subject to be unsuitable for the study e.g., Active malignant tumor
- •Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers
- •Any life-threatening condition with life expectancy less than 6months
- •Mental condition (dementia, alcohol or drug abuse) which may be affect study compliance or prevent understanding of the aims, investigational procedures or possible consequences of the study
- •High risk due to malignant hypertension
- •The conditions associated with increased risk of bradycardiac events
- •Subjects with severe liver disease
- •Subjects requiring dialysis
- •Increased bleeding risk
- •History of cerebral hemorrhage, gastrointestinal bleeding within 6months, major surgical procedure within 30days
- •Thrombocytopenia or leukopenia
- •Positive pregnancy test or is known to be pregnant
研究组 & 干预措施
Ticagrelor
Experimental
干预措施: Ticagrelor (Drug)
Clopidogrel
Active Comparator
干预措施: Clopidogrel (Drug)
结局指标
主要结局
The time to first occurrence of any bleeding event
时间窗: 1year
Safety of Ticagrelor compared to Clopidogrel by measuring the time to first occurrence of any bleeding event(including major, minor bleedings)
The time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke
时间窗: 1year
Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke
次要结局
- Adverse events following discontinuation of study medication(1year)
- Serious adverse events(1year)
- The time to occurrence of composite events(1year)
- The time to occurrence of death from any cause(1year)
- Number of patients with net clinical benefit of any total bleeding and any event from the composite of death from vascular causes, Myocardial Infarction and stroke.(1year)
- The time to first occurrence of major bleeding event(1year)
- The time to first occurrence of minor bleeding event(1year)
- The time to first occurrence of death from vascular causes(1year)
- The time to first occurrence of major bleeding event or minor bleeding event(1year)
- The time of first occurrence of discontinuation of study medication from any bleeding event(1year)
- The time to first occurrence of stroke(1year)
- The time to first occurrence of Bleeding Academic Research Consortium (BARC) bleeding event from type 1 to type 5(1year)
- Non serious adverse events(1year)
- The time to first occurrence of myocardial infarction(1year)
研究者
Seung-Jung Park
MD, PhD
Asan Medical Center
研究点 (10)
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