Effect of Lower Loading Dose of Prasugrel Compared With Conventional Loading Dose of Clopidogrel and Prasugrel in Korean Coronary Artery Disease Patients Undergoing Coronary Angiography
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Platelet reactivity
研究概览
简要总结
Although prasugrel, recently available thienopyridine derivative, exhibits rapid and potent platelet inhibition, concerns of low on-treatment platelet reactivity have been suggested especially in East Asian ethnicities. The investigators compared the effect of lower loading dose of prasugrel with conventional loading dose of clopidogrel and prasugrel.
详细描述
Although clopidogrel together aspirin has been a backbone of anti-platelet therapy in coronary artery disease patients, clopidogrel has several limitations. It has delayed onset of peak concentration and pharmacodynamic inter-patient response variability resulting in high on-treatment platelet reactivity (HPR). Those demerits are known to be associated with adverse cardiovascular outcomes.
Prasugrel has a more effective metabolism pathway than clopidogrel and exhibits more rapid and potent platelet inhibition. Recent guidelines recommend prasugrel as a first line antiplatelet agent or put precedence over clopidogrel for the patients with acute coronary syndrome. However, there have been concerns of different pharmacodynamic and pharmacokinetic response to prasugrel in East Asian ethnicities.
In addition, lower loading dose of prasugrel exhibited more potent pharmacodynamic effect than clopidogrel 600 mg with comparable efficacy compared to conventional loading dose of prasugrel in healthy Korean subjects.
The investigators compare the antiplatelet effect of lower loading dose of prasugrel 30 mg with conventional loading dose of clopidogrel 600 mg and prasugrel 60 mg in Korean coronary artery disease patients undergoing elective coronary angiography.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 80 years
- •Stable or unstable angina
- •Planned to undergo elective coronary angiography
排除标准
- •Previous history of transient ischemic attack or stroke
- •Intracranial neoplasm
- •Uncontrolled malignant disease
- •History of antiplatelet or anticoagulation treatment within 1 month
- •Contraindication to the study drug
- •Bleeding diathesis
- •Hemoglobin < 10 g/dl
- •Platelet count < 100,000/mm3
- •Significant renal insufficiency (glomerular filtration rate <60 mL/min/1.73 m2)
- •Significant hepatic impairment (Serum liver enzyme or bilirubin > 3 times normal limit)
- •Body weight < 50 kg
研究组 & 干预措施
Clopidogrel 600 mg
Patients administer conventional loading dose of clopidogrel 600 mg as active comparators.
干预措施: Clopidogrel 600 mg (Drug)
Prasugrel 30 mg
Patients administer lower loading dose of prasugrel 30 mg.
干预措施: Prasugrel 30 mg (Drug)
Prasugrel 60 mg
Patients administer conventional loading dose of prasugrel 60 mg as active comparators.
干预措施: Prasugrel 60 mg (Drug)
结局指标
主要结局
Platelet reactivity
时间窗: at 6 hours after administration of study drug. (2 hours for prasugrel groups)
Platelet reactivity was measured using traditional light transmission aggregometry (LTA), VerifyNow (Accumetrics, San Diego, CA, USA), and multiple electrode aggregometry (MEA, Dynabyte Medical, Munich, Germany). The platelet reactivity was measured at 6 hours after study drug administration (after 2 hours for the prasugrel groups).
次要结局
- Percent inhibition(at 6 hours after administration of study drug. (2 hours for prasugrel groups))
- HPR(at 6 hours after administration of study drug. (2 hours for prasugrel groups))
- LPR(at 6 hours after administration of study drug. (2 hours for prasugrel groups))
- Bleeding event(30 days after study drug administration)
- Adverse reaction(30 days after study drug administration)
研究者
Moo Hyun Kim
MD. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A University Hospital
Dong-A University