Platelet Reactivity After an Eastern Asian Loading Dose of Prasugrel in Taiwanese Patients With Acute Myocardial Infarction: PREP-TAMI Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- platelet reactivity (PRU) after loading of prasugrel at 12 hours
研究概览
简要总结
Prasugrel has a faster onset of action and greater platelet inhibition with less inter-individual response variability than clopidogrel. Japan and Taiwan are the only two nations where adjusted/Asian dose of prasugrel (loading dose (LD)/maintenance (MD): 20/3.75 mg) was approved for clinical use. However, there is no data regarding the effectiveness of adjusted dose of prasugrel on platelet reactivity in Taiwanese patients with acute coronary syndrome (ACS). This study aim to evaluate the pharmacodynamic of the Asian dose prasugrel on the platelet reactivity after percutaneous coronary intervention (PCI) for patients with ACS.
详细描述
Rationale and Background Prasugrel provides more potent and rapid platelet inhibition compared to Clopidogrel.
Rapid and effective inhibition of the platelet P2Y12 receptor is of pivotal importance in patients with AMI who undergo PCI.
Prasugrel (60 mg loading and 10 mg/day maintenance dose) is a new generation P2Y12 inhibitor that achieves greater and faster platelet inhibition comparing with clopidogrel in patients undergoing PCI.
As revealed by 2 head-to-head studies, reducing Prasugrel dosages to 20/3.75 LD/MD (mg) was still efficacious but led to less bleeding events than the original 60/10 LD/MD (mg).
In TRITON-TIMI 38 trial, prasugrel was associated with not only significantly less ischemic events but also more non-CABG TIMI major bleeding, as compared to Clopidogrel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mentally competent to provide an informed consent.
- •A person being diagnosed with acute coronary syndrome and arranged for a percutaneous coronary intervention.
排除标准
- •A history of hemorrhagic stroke at any time in the past.
- •Active internal bleeding or has a history of a bleeding disorder (i.e. hemophilia).
- •Severe liver disease; for example, cirrhosis.
结局指标
主要结局
platelet reactivity (PRU) after loading of prasugrel at 12 hours
时间窗: 12 hours
PRU 12 hours after a loading dose
次要结局
- platelet reactivity (PRU) after loading of prasugrel at 1 hour(one hour)
- platelet reactivity (PRU) after loading of prasugrel at 48 hours(48 hours)
- platelet reactivity (PRU) after loading of prasugrel at 3 hours(3 hours)
- ISTH Major bleeding(day 7 after a loading dose of prasugrel)
研究者
Chen-Rong, Tsao M.D.
Chief of Cardiology
Feng Yuan Hospital, Ministry of Health and Welfare