Does Pantoprazole Reduce the Anti-platelet Effect of Clopidogrel?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Number of participants with more than 5 Ω of impedance after intervention by an aggregometer which measures platelet aggregation in whole blood samples
研究概览
简要总结
The investigators sought to evaluate the influence of pantoprazole, indicated as less effective than other proton pump inhibitors, on the antiplatelet effect of clopidogrel, with stratification of the population according to the presence of cytochrome (CYP) 2C19 polymorphism.
详细描述
Participants being treated with a maintenance dose of 75 mg clopidogrel and 100 mg aspirin daily after previous PCI with coronary stenting were included in the study. Participants were randomly assigned to either the pantoprazole 40 mg once-daily group or the ranitidine 150 mg twice-daily group using a computer-generated randomized table. An independent investigator generated the random allocation sequence. Blood samples were collected at 9:00 on day prior to treatment (day 0) and on day 9. Measuring impedance was performed by one independent investigator in a blinded manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients being treated with a maintenance dose of 75 mg clopidogrel and 100 mg aspirin daily after previous PCI with coronary stenting were included in the study. All patients received standardized therapy with a loading dose of 600 mg of clopidogrel hydrogen sulfate and 400 mg aspirin.
- •All participants had a normal platelet count (150,000-450,000/mL).
排除标准
- •Patients with severe liver disorders, current gastrointestinal disorders, a current infection, congestive heart failure, or a known bleeding disorder as well as patients on bivalirudin or glycoprotein IIb/III antagonists within the last 7 days were excluded from the study.
研究组 & 干预措施
Pantoprazole
Drug: Pantoprazole 40 mg once-daily
干预措施: Pantoprazole (Drug)
Ranitidine
Drug: Ranitidine 150 mg twice-daily
干预措施: Ranitidine (Drug)
结局指标
主要结局
Number of participants with more than 5 Ω of impedance after intervention by an aggregometer which measures platelet aggregation in whole blood samples
时间窗: 8 days
8 days after administration of pantoprazole (or ranitidine)
次要结局
- Number of participants with gastrointestinal bleeding(up to 2weeks)
- Number of participants with reccured coronary artery disease(up to 2weeks)
- Change of the impedance value (Ω) by an aggregometer which measures platelet aggregation in whole blood samples(baseline and 8days)
研究者
Nayoung Kim
PI (professor)
Seoul National University Bundang Hospital