A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Hispanic Patients With Stable Coronary Artery Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose
研究概览
简要总结
The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic patients with stable coronary artery disease.
详细描述
A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor versus Clopidogrel in Hispanic Patients with Stable Coronary Artery Disease
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
- 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 signed and dated informed consent before initiation of any study-related procedures
- •Male or female patients aged 18 years or older Documented stable CAD fulfilling and taking 75-100mg ASA daily treatment
- •Females must be post menopausal or surgically sterile Self-identified as Hispanic
排除标准
- •Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve) or dual antiplatelet treatment (e.g., clopidogrel, prasugrel, ASA dose other than 75 to 100 mg daily) during study period
- •Patients who had ACS or stent placed within 12 months of screening Patients with a history of moderate or severe hepatic impairment
- •Current smokers, including the use of tobacco containing products in the past 1 month of randomization
- •Patients requiring dialysis
研究组 & 干预措施
Ticagrelor
干预措施: Ticagrelor (Drug)
Clopidogrel
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose
时间窗: At 2 hours after the loading dose
Participants with low (\<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value
次要结局
- Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses(Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose)
- AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses(Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose)
- Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8(At 2 hours and 8 hours on Day 7 after multiple doses, and at the end of dosing interval on Day 8)
- Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose(At 0.5 and 8 hours after the loading dose)