Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer and Gastrointestinal Bleeding
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Recurrent Peptic Ulcer
研究概览
简要总结
Proton Pump Inhibitors (PPI) can prevent the recurrence of peptic ulcer in clopidogrel users.
详细描述
The aim of the prospective, randomized study is to investigate the efficacy of PPI in prevention of ulcer recurrence for clopidogrel users. We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months. The ulcer recurrence rate between the treatment groups will be compared.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months.
排除标准
- •1.serious disease 2.refuse informed consent
研究组 & 干预措施
Esomeprazole plus clopidogrel group
esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
干预措施: esomeprazole (Drug)
结局指标
主要结局
Recurrent Peptic Ulcer
时间窗: 6 months
Number of participants with recurrent peptic ulcer within 6 months
次要结局
- Peptic Ulcer Bleeding(6 months)
研究者
Ping-I (William) Hsu, M.D.
Chief, Gastroenterology Division
Kaohsiung Veterans General Hospital.