Phase 3 Study Comparing the Efficacy and Safety of Prasugrel and Clopidogrel in Acute Coronary Syndrome Patients With CYP2C19 Polymorphism Who Undergo Percutaneous Coronary Intervention.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- HPR 1 day
研究概览
简要总结
The investigators hypothesize that reduced loading dose of prasugrel followed by reduced maintenance dose of prasugrel in acute coronary syndrome patients with CYP2C19 polymorphism undergoing percutaneous coronary intervention might exhibit lower platelet reactivity 24 hours and 30 days later which is associated with major adverse cardiovascular events.
详细描述
Antiplatelet treatment is recommended worldwide for the secondary prevention and clopidogrel is an essential drug. But clopidogrel has limited value because of its pharmacodynamic interpatient variability and delayed onset time.
It is well known that patients who carry a common reduced-function CYP2C19 allele have a lower level of active metabolite of clopidogrel, diminished platelet inhibition, and furthermore, higher rate of major adverse cardiovascular events than noncarriers.
To achieve maximum plateau more rapidly and reduce the rate of high on-treatment platelet reactivity, higher loading dose of clopidogrel, up to 600 mg, is recommended. Although, however, the higher loading dose of clopidogrel, many patients still remain as non-responder.
Incidence of patients with clopidogrel resistance, especially CYP2C19*2 and *3, which encounter loss function, is higher in Eastern Asian peoples than Western peoples. Some studies report incidence rate of clopidogrel resistance in Eastern Asian peoples up to 99%.
However, the metabolism is not influenced by the presence of CYP2C19 genetic variation and prasugrel shows potent platelet inhibition. Although prasugrel exhibit potent platelet inhibition, recent reports describe the possible over inhibition of platelet especially in the East Asian people.
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
- Single (Participant)
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)
- •History of stroke or transient ischemic attack
- •History of upper gastrointestinal bleeding in recent 6 months
- •Renal dysfunction defined by serum creatinine > 2.5 mg/dl
- •Severe hepatic dysfunction defined by Child-Pugh criteria B or C
- •Bleeding tendency
- •Anticoagulation treatment including warfarin
- •Thrombocytopenia defined by platelet < 100,000/ml
- •Anemia defined by hemoglobin < 10 g/dl
- •Contraindication for antiplatelet treatment or anticoagulation treatment
- •History of administer glycoprotein IIb/IIIa inhibitor in recent 24hrs or planned to
研究组 & 干预措施
Prasugrel
Loading and maintenance dose of prasugrel
干预措施: Prasugrel (Drug)
Clopidogrel
Loading and maintenance dose of clopidogrel
干预措施: Clopidogrel (Drug)
结局指标
主要结局
HPR 1 day
时间窗: 24 hours after PCI
High platelet reactivity unit defined as platelet reactivity of 242u or more using VerifyNow method at 24 hours after PCI
次要结局
- Bleeding(30 days)
- HPR by VASP at 30 days(30 days from PCI)
- MACE(30 days)
- HPRs(4 hours after PCI, 30 days after PCI)
- HPR by VASP at 24 hours(24 hours from PCI)
研究者
Moo Hyun Kim
MD. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A University Hospital
Dong-A University
