A Randomised, Double-blind, Double-dummy, Parallel Group, International (Asian), Multicenter, Phase 3 Study to Assess Safety and Efficacy of AZD6140 on Top of Low Dose Acetyl Salicylic Acid (ASA) Versus Clopidogrel on Top of Low Dose ASA in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes(ACS) for Whom PCI is Planned
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 801
- 试验地点
- 1
- 主要终点
- Major Bleeding
研究概览
简要总结
The purpose of the study is to assess the efficacy (prevention of vascular events) and safety (especially bleedings) of Ticagrelor (AZD6140) compared with Clopidogrel, both given on top of low dose aspirin, in Asian/Japanese patients with acute coronary syndrome and a planned percutaneous coronary intervention (PCI).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 signed informed consent
- •Index event of non-ST or ST segment elevation ACS
排除标准
- •Index event is an acute complication of percutaneous coronary intervention
- •Patient has undergone Percutaneous Coronary Intervention (PCI) after the index event before the first dose of study treatment
- •Oral anticoagulation therapy that cannot be stopped
- •The conditions associated with increased risk of bradycardiac events
研究组 & 干预措施
2
Clopidogrel
干预措施: Acetylsalicylic acid ASA (Drug)
1
Ticagrelor (AZD6140)
干预措施: Ticagrelor (Drug)
1
Ticagrelor (AZD6140)
干预措施: Acetylsalicylic acid ASA (Drug)
2
Clopidogrel
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Major Bleeding
时间窗: Ongoing up to12 months
Time to first occurrence of any major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.
Major Adverse Cardiac Events (MACE)
时间窗: Ongoing up to 12 months
Time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.
次要结局
- Major and Minor Bleeding(Ongoing up to12 months)
- Composite of All-cause Mortality, MI or Stroke(Ongoing up to 12 months)