The Optimal Strategy of Switching From Clopidogrel to Ticagrelor in Patients With Complexity of Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Platelet function assessments
研究概览
简要总结
The study is to further exploring the optimal switching strategy by evaluating the pharmacodynamic responses as well as adverse events in patients with complexity of coronary artery disease managed by percutaneous coronary intervention (PCI). All participants will be divided into three groups and recieving ticagrelor 90mg plus aspirin 100mg at 12 hours after the last dose of clopidogrel; recieving ticagrelor 90mg plus aspirin 100mg at 24 hours after the last dose of clopidogrel; recieving ticagrelor 180mg plus aspirin 100mg at 24 hours after the last dose of clopidogrel.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-75
- •Patients with complexity of CAD determined by coronary angiography and implanted stent successfully
- •Taking clopidogrel 75mg daily over 5 days or paients never took clopidogrel previously should receive 300-600mg drugs at least 12 hours before coronary angiography
- •Agreeing to participate in this trial and signed the written informed consent.
排除标准
- •They contraindicated with ticagrelor (including: allergying to ticagrelor or its active metabolite
- •Concomitanting therapy with a strong cytochrome P-450 3A inhibitor or inducer
- •Previous intracranial haemorrhage or ongoing bleeds
- •Moderate or severe hepatic impairment)
- •Having a previous medication with ticagrelor or long term anticoagulation
- •Having a history of asthma or chronic obstructive pulmonary disease (COPD) and recurrent attacked
- •Having an uncontrolled hypertension>180/110mmHg
- •Having a hemoglobin<100g/L 9.Having a platelet counts<100×10^9/L
- •Having severe renal impairment (clearance<30mL/min)
- •Having a history of hepaein-induced thrombocytopenia (HIT)
- •Having a pregnancy or were during lactation.
研究组 & 干预措施
Ticagrelor, 90mg, 12h
干预措施: Ticagrelor (Drug)
Ticagrelor, 90mg, 24h
干预措施: Ticagrelor (Drug)
Ticagrelor, 180mg, 24h
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Platelet function assessments
时间窗: 7 Days
The primary endpoint was the comparations between the three projects for the value changes of maximal platelet aggregation (MPA) measured by Light Transmittance Aggregometry (LTA) at 2 hours after switching strategies.
次要结局
未报告次要终点
研究者
Han Yaling, MD
General Hospital of Shenyang Military Region
General Hospital of Shenyang Military Region