Comparison of Prasugrel and Clopidogrel Reloading on High Platelet Reactivity in Clopidogrel-loaded Patients Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- HPR at 24 hours
研究概览
简要总结
High platelet reactivity unit (PRU) after loading dose clopidogrel in patients undergoing percutaneous coronary intervention (PCI) is related to high risk of short and long term recurrent ischemic events including stent thrombosis.
The investigators hypothesize that additional loading of prasugrel in patients with high PRU after clopidogrel loading would be superior to additional loading of clopidogrel in reducing platelet reactivity and thereby result in lower risk of short term recurrent ischemic events.
详细描述
Dual antiplatelet therapy with acetylsalicyclic acid (ASA) and additional clopidogrel is now standard regimen for the prevention of recurrent ischemic events in patients who undergo PCI.
But decreased effect of clopidogrel in a group of patients was reported and they are known to be associated with high risk of recurrent ischemic event. Decreased effect of clopidogrel is mainly resulted from decreased function to metabolite prodrug, clopidogrel to active form of drug.
Prasugrel, newer thienopyridine has been recently developed and showed advantages to clopidogrel. Prasugrel is known to have shorter onset time to achieve steady state level than clopidogrel and constant pharmacologic effect regardless of patient diversity.
High PRU after loading dose clopidogrel in patients undergoing PCI is known to be related to increased risk of short and long term recurrent ischemic events including stent thrombosis. Prasugrel has been reported to be effective in reducing platelet reactivity in patients showing resistance to clopidogrel and high PRU.
The investigators hypothesize that additional loading of prasugrel in patients with high PRU after clopidogrel loading would be superior to additional loading of clopidogrel in reducing platelet reactivity and thereby result in reduced risk of short term recurrent ischemic events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute coronary syndrome
- •Patients planned to undergo percutaneous transluminal coronary angioplasty
- •Patients who agreed to the experimental plan which was permitted by IRB
排除标准
- •Low body weight (<50kg)
- •Urgent PCI for ACS
- •Use of glycoprotein IIb/IIIa inhibitor in recent 24hrs or planned to
- •History of transient ischemic attack
- •History of upper gastrointestinal bleeding in recent 6 months
- •Renal dysfunction defined as serum creatinine > 2.5 mg/dl
- •Severe hepatic dysfunction defined as serum transaminase > 3 times normal limit
- •Bleeding tendency
- •Anticoagulation treatment including warfarin
- •Thrombocytopenia defined by platelet < 100,000/ml
- •Anemia defined by hemoglobin < 10 g/dl
- •Contraindication for study drugs
研究组 & 干预措施
Prasugrel
Reloading with prasugrel 20mg & followed by administration of 5mg/day for 30 days
干预措施: Prasugrel (Drug)
Clopidogrel
Reloading with clopidogrel 300mg and followed by administration of clopidogrel 75 mg/day for 30 days
干预措施: Clopidogrel (Drug)
结局指标
主要结局
HPR at 24 hours
时间窗: 24 hours
Persistently high platelet reactivity after PCI. PRU is measured by methods of VerifyNow device and HPRU is defined as PRU of 240 or more.
次要结局
- Bleeding(30 days (1 month))
- MACE(30 days (1 month))
- HPRs(4 hours after PCI, 30 days after PCI)
- Periprocedural myocardial infarction(48 hours after PCI)
- Periprocedural myocardial injury(48 hours after PCI)
研究者
Moo Hyun Kim
MD. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A University Hospital
Dong-A University