Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- P2Y12 reaction units
研究概览
简要总结
The investigators examine the influence of esomeprazole versus famotidine on antiplatelet action of clopidogrel associated with aspirin. At least 100 consecutive patients suffering from acute coronary syndrome or undergoing coronary artery stent implantation , who received aspirin (80 - 160 mg/day) and clopidogrel (300 mg loading dose, followed by 75 mg/day or 75mg/day for at least 7 consecutive days), are randomised to receive either esomeprazole 20 mg daily vs famotidine 40 mg daily in a double blinded manner. Clopidogrel effect was tested by measuring residual platelet reactivity (RPR) to ADP by VerifyNow P2Y12 assay (Accumetrics Inc, San Diego, Calif). At baseline, whole blood will be obtained for RPR at least 12 h after clopidogrel loading dose or at least 7 days of maintaince dose. Immediately obtaining the baseline blood, patients will be randomized to receive either esomeprazole (20 mg/day) or famotidine 40 mg/day for 28 days. Double blinding will be performed by encapsulation of study drugs. RPR will be measured again at the 28th day.
The investigators will compare the % inhibition and the P2Y12 reaction Units (PRU) at the 28-day treatment period in the 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients suffering from acute coronary syndrome or undergoing coronary artery stent implantation (PCI) , who received aspirin (80 - 160 mg/day) and clopidogrel (300 mg loading dose, followed by 75 mg/day), are recruited.
排除标准
- •known active peptic ulcer disease or gastrointestinal within 8 wk
- •known iron deficiency anemia with Hb < 10 gm/dl
- •mechanical ventilation
- •active cancer, liver cirrhosis, end-stage renal failure
- •life expectancy < 1 yr
- •known allergic to aspirin, clopidogrel, famotidine or esomeprazole
- •pregnancy, lactation, child-bearing potential in the absence of contraception,
- •co-prescription of NSAID, corticosteroid, or warfarin
- •non-oral feeding or impaired GI absorption e.g. vomiting
- •patient on proton pump inhibitor within 4 weeks
研究组 & 干预措施
1
oral esomeprazole 20 mg daily
干预措施: esomeprazole 20 mg daily (Drug)
2
oral famotidine 40mg daily
干预措施: famotidine 40 mg daily (Drug)
结局指标
主要结局
P2Y12 reaction units
时间窗: 28 days
次要结局
- percent inhibition(28 days)