Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The platelet inhibition ratio
研究概览
简要总结
Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor reduces thrombotic events in patients with coronary artery disease, but these benefits come at the expense of increased risk of bleeding when compared with aspirin monotherapy. Increased evidence showed that P2Y12 inhibitor monotherapy still maintain antiischemic efficacy while reducing the bleeding risk compared with DAPT. Therefore, the investigators performed this study to observe the efficacy of ticagrelor in comparison to clopidogrel in Chinese patients with stable CAD.
详细描述
Ticagrelor is a novel, direct-acting, reversibly binding P2Y12 receptor antagonist. When related with clopidogrel, ticagrelor exhibits a more potent and more predictable antiplatelet effect with a faster onset and offset of action. Current guidelines give a recommendation on the use of dual antiplatelet therapy support ticagrelor 90 mg twice daily over clopidogrel 75 mg daily in addition to aspirin in CAD patients. However, increasing evidence showed ticagrelor increased the risk of bleeding. Recent studies showed that P2Y12 inhibitor monotherapy still maintain antiischemic efficacy while reducing the bleeding risk compared with DAPT. So the investigators performed this randomized, single-blind, crossover clinical trial to observe the effects of standard-dose ticagrelor and standard-dose clopidogrel on platelet reactivity in Chinese patients with stable CAD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Aged ≥18 years
- •Subjects had documented with stable CAD
- •Women were required to be postmenopausal or surgically sterile
- •Patients were required to discontinue clopidogrel or ticagrelor at least 14 days before randomization
- •Patients were required to discontinue aspirin at least 14 days before randomization.
排除标准
- •Acute coronary syndrome
- •Planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP) receptor antagonists other than the study medication, or anticoagulant therapy during the study period
- •Platelet count <10×10^4/μL
- •Hstory of bleeding tendency
- •Diagnosed as respiratory or circulatory instability
- •Allergy to ticagrelor or clopidogrel
研究组 & 干预措施
Ticagrelor
To observe the safety and efficacy of standard-dose ticagrelor in Chinese patients with Stable Coronary Artery Disease
干预措施: Ticagrelor 90mg (Drug)
Ticagrelor
To observe the safety and efficacy of standard-dose ticagrelor in Chinese patients with Stable Coronary Artery Disease
干预措施: Clopidogrel 75mg (Drug)
Clopidogrel
To observe the safety and efficacy of standard-dose clopidogrel in Chinese patients with Stable Coronary Artery Disease
干预措施: Ticagrelor 90mg (Drug)
Clopidogrel
To observe the safety and efficacy of standard-dose clopidogrel in Chinese patients with Stable Coronary Artery Disease
干预措施: Clopidogrel 75mg (Drug)
结局指标
主要结局
The platelet inhibition ratio
时间窗: up to 3 months
Thromboelastogram was used to measure platelet inhibition ratio.
次要结局
- The platelet aggregation ratio.(up to 3 months)
研究者
Yue LI
Professor
First Affiliated Hospital of Harbin Medical University