Platelet Aggregation and Adenosine Levels Among Patients With Stable Chronic Coronary Artery Disease Taking Ticagrelor or Prasugrel
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- To compare platelet inhibition between the two groups (ticagrelor and prasugrel)
研究概览
简要总结
Prospective, single-center, double blind, double dummy, randomized trial. Platelet function tests and adenosine levels were assessed at baseline and 15 days after taking Ticagrelor with Prasugrel placebo or Prasugrel with Ticagrelor placebo in stable patients with coronary artery disease
详细描述
This was a prospective, double blinded, randomized trial that compared platelet inhibition and adenosine levels with ticagrelor (180mg loading dose, followed by 90 mg BID) versus prasugrel (60mg loading dose, followed by 10 mg QD) .
Patients were eligible if they were between 18 and 75 years old, were on aspirin without P2Y12 inhibitor at baseline and > 1 year after documented ACS. Platelet aggregation was compared with the Multiplate ADP® assay, performed at baseline and after 15 days on study medication. Adenosine plasma levels were measured with high performance liquid chromatography at the same time points
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
- Triple (Participant, Care Provider, Investigator)
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
- 是
入选标准
- •between 18 and 75 years old
- •were on aspirin
- •without P2Y12 inhibitor at baseline
- •> 1 year after documented acute coronary syndrome
排除标准
- •use of oral anticoagulation or P2Y12 at baseline
- •Weight < 60kg
- •History of tia or stroke
- •Any coagulation disorders
- •Refuse to sign the written consent
研究组 & 干预措施
Prasugrel group
Prasugrel (60mg loading dose, followed by 10 mg QD for 15 days)
- Ticagrelor placebo (Placebo loading dose followed by two pills a day)
干预措施: Prasugrel (Drug)
Prasugrel group
Prasugrel (60mg loading dose, followed by 10 mg QD for 15 days)
- Ticagrelor placebo (Placebo loading dose followed by two pills a day)
干预措施: Ticagrelor (Drug)
Ticagrelor group
Ticagrelor (180mg loading dose, followed by 90 mg BID)
- Prasugrel placebo (Placebo loading dose followed by one pill a day)
干预措施: Prasugrel (Drug)
Ticagrelor group
Ticagrelor (180mg loading dose, followed by 90 mg BID)
- Prasugrel placebo (Placebo loading dose followed by one pill a day)
干预措施: Ticagrelor (Drug)
结局指标
主要结局
To compare platelet inhibition between the two groups (ticagrelor and prasugrel)
时间窗: 15 days
Platelet aggregation was compared with the Multiplate ADP® assay at baseline and after 15 days on study medication
To compare adenosine levels between the two groups (ticagrelor and prasugrel)
时间窗: 15 days
Adenosine plasma levels were measured at baseline and after 15 days with high performance liquid chromatography at the same time points
次要结局
未报告次要终点
研究者
Jose Carlos Nicolau
Director Coronary Care Unit
University of Sao Paulo