NCT01864005已完成4 期
A Multicentre, Open-label, Randomized, 6-week, Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel With Aspirin as Background Therapy in Chinese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)
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
- AstraZeneca
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the Percentage Inhibition of the P2Y12 Receptor
研究概览
简要总结
The purpose of this study is to test the hypothesis that the onset of the antiplatelet effect of ticagrelor is more rapid and greater than clopidogrel in Chinese patients with ACS.
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
- •Provision of informed consent prior to any study specific procedures
- •Female or male aged at least 18 years
- •Females of child-bearing potential must have a negative urine pregnancy test at enrolment and be willing to use reliable contraception
- •Index event of non-ST or ST segment elevation ACS.
排除标准
- •1.Contraindication or other reason that clopidogrel or ticagrelor should not be administered (eg, hypersensitivity, active bleeding, moderate or severe liver disease, history of previous intracranial bleed, GI bleed within the past 6 months, major surgery within 30 days)
- •Oral anticoagulation therapy or GP IIb/IIIa receptor antagonists therapy within 30 days prior to randomisation or cannot be stopped
- •Ticagrelor or clopidogrel or other P2Y12 inhibitors within 14 days prior to randomisation
- •Requires dialysis
- •Nonselective non-steroidal anti-inflammatory drugs (NSAIDs) and prostacyclins (PGI2) therapy that cannot be stopped
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 Percentage Inhibition of the P2Y12 Receptor
时间窗: at 2 hours after first dose of study drug
Note: the primary endpoint was changed per the statistical analysis plan prior database lock.
次要结局
- the Percentage Inhibition of the P2Y12 Receptor(at 6 weeks after first dose of study drug)
研究者
研究点 (1)
Loading locations...
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